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Designing an implementation intervention with the Behaviour Change Wheel for health provider smoking cessation care for Australian Indigenous pregnant women

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Background Indigenous smoking rates are up to 80% among pregnant women: prevalence among pregnant Australian Indigenous women was 45% in 2014, contributing significantly to the health gap for Indigenous Australians. We aimed to develop an implementation intervention to improve smoking cessation care (SCC) for pregnant Indigenous smokers, an outcome to be achieved by training health providers at Aboriginal Medical Services (AMS) in a culturally competent approach, developed collaboratively with AMS. Method The Behaviour Change Wheel (BCW), incorporating the COM-B model (capability, opportunity and motivation for behavioural interventions), provided a framework for the development of the Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy implementation intervention at provider and patient levels. We identified evidence-practice gaps through (i) systematic literature reviews, (ii) a national survey of clinicians and (iii) a qualitative study of smoking and quitting with Aboriginal mothers. We followed the three stages recommended in Michie et al.’s “Behaviour Change Wheel” guide. Results Targets identified for health provider behaviour change included the following: capability (psychological capability, knowledge and skills) by training clinicians in pharmacotherapy to assist women to quit; motivation (optimism) by presenting evidence of effectiveness, and positive testimonials from patients and clinicians; and opportunity (environmental context and resources) by promoting a whole-of-service approach and structuring consultations using a flipchart and prompts. Education and training were selected as the main intervention functions. For health providers, the delivery mode was webinar, to accommodate time and location constraints, bringing the training to the services; for patients, face-to-face consultations were supported by a booklet embedded with videos to improve patients’ capability, opportunity and motivation. Conclusions The ICAN QUIT in Pregnancy was an intervention to train health providers at Aboriginal Medical Services in how to implement culturally competent evidence-based practice including counselling and nicotine replacement therapy for pregnant patients who smoke. The BCW aided in scientifically and systematically informing this targeted implementation intervention based on the identified gaps in SCC by health providers. Multiple factors impact at systemic, provider, community and individual levels. This process was therefore important for defining the design and intervention components, prior to a conducting a pilot feasibility trial, then leading on to a full clinical trial.
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R E S E A R C H Open Access
Designing an implementation intervention
with the Behaviour Change Wheel for
health provider smoking cessation care for
Australian Indigenous pregnant women
Gillian S. Gould
1*
, Yael Bar-Zeev
1
, Michelle Bovill
1
, Lou Atkins
2
, Maree Gruppetta
1
, Marilyn J Clarke
3
and Billie Bonevski
1
Abstract
Background: Indigenous smoking rates are up to 80% among pregnant women: prevalence among pregnant
Australian Indigenous women was 45% in 2014, contributing significantly to the health gap for Indigenous Australians.
We aimed to develop an implementation intervention to improve smoking cessation care (SCC) for pregnant Indigenous
smokers, an outcome to be achieved by training health providers at Aboriginal Medical Services (AMS) in a culturally
competent approach, developed collaboratively with AMS.
Method: The Behaviour Change Wheel (BCW), incorporating the COM-B model (capability, opportunity and motivation
for behavioural interventions), provided a framework for the development of the Indigenous Counselling and Nicotine
(ICAN) QUIT in Pregnancy implementation intervention at provider and patient levels. We identified evidence-practice
gaps through (i) systematic literature reviews, (ii) a national survey of clinicians and (iii) a qualitative study of smoking and
quitting with Aboriginal mothers. We followed the three stages recommended in Michie et al.sBehaviour Change
Wheelguide.
Results: Targets identified for health provider behaviour change included the following: capability (psychological
capability, knowledge and skills) by training clinicians in pharmacotherapy to assist women to quit; motivation
(optimism) by presenting evidence of effectiveness, and positive testimonials from patients and clinicians; and
opportunity (environmental context and resources) by promoting a whole-of-service approach and structuring
consultations using a flipchart and prompts. Education and training were selected as the main intervention
functions. For health providers, the delivery mode was webinar, to accommodate time and location constraints,
bringing the training to the services; for patients, face-to-face consultations were supported by a booklet embedded
with videos to improve patientscapability, opportunity and motivation.
Conclusions: The ICAN QUIT in Pregnancy was an intervention to train health providers at Aboriginal Medical Services
in how to implement culturally competent evidence-based practice including counselling and nicotine replacement
therapy for pregnant patients who smoke. The BCW aided in scientifically and systematically informing this targeted
implementation intervention based on the identified gaps in SCC by health providers. Multiple factors impact at
systemic, provider, community and individual levels. This process was therefore important for defining the design and
intervention components, prior to a conducting a pilot feasibility trial, then leading on to a full clinical trial.
Keywords: Behaviour Change Wheel, Smoking cessation, Pregnancy, Health provider training, Indigenous populations
* Correspondence: Gillian.Gould@newcastle.edu.au
1
School of Medicine and Public Health, University of Newcastle, University
Drive, Callaghan, NSW 2308, Australia
Full list of author information is available at the end of the article
© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Gould et al. Implementation Science (2017) 12:114
DOI 10.1186/s13012-017-0645-1
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
Background
Implementation science is the study of the methods to
promote the systematic uptake of evidence-based prac-
tice into routine care to improve the quality and effect-
iveness of health services [1]. In this case, the challenge
was to implement what is known to be effective for
smoking cessation care (SCC) during pregnancy, into
the context of health providers working with Indigenous
women served by Aboriginal Community Controlled
Health Services (ACCHS).
Indigenous smoking rates are high during pregnancy:
in some communities, up to 80% of pregnant women
smoke or use tobacco in another form [2]. In Australia,
pregnant Indigenous women smoke at almost four times
the rate of their non-Indigenous counterparts (45% com-
pared to 12% in 2014) [3]. Smoking prevalence of preg-
nant Australian Indigenous women has been slow to
decline, and cessation rates in pregnancy are half those
of non-Indigenous counterparts [3].
Impediments to smoking cessation are complex in this
setting and reveal individual-, community- and system-
level factors [4]. A very high baseline prevalence of
smoking among Indigenous families and communities is
one factor that may jeopardise the capacity of individual
people to quit [5]. Other important factors perpetuating
Indigenous tobacco smoking in Australia include the
detrimental impact of European colonisation causing
dispossession, degradation and loss, and during which
tobacco was introduced to many Indigenous communi-
ties for the first time; how Indigenous workers were
often only paid in tobacco; government policies such as
children being forcibly removed from parents (termed
the stolen generation); and racism [2]. Tobacco smok-
ing has become a norm and a social lubricant in many
and diverse Australian Indigenous communities [2]. Des-
pite these factors, more Indigenous smokers want to quit
smoking than their general population counterparts but
are less likely to succeed [6, 7]. Another important factor
is the necessity to develop a strategy to address the
needs of health professionals, who have been reported to
seldom perform all the recommended steps for smoking
cessation care for pregnant women [8, 9].
Theory-based interventions are recommended when
designing complex approaches to behaviour change and
aid in the specification of potentially active ingredients
[10]. In defining the components of such an interven-
tion, an analysis of the target behaviour is a key [11].
Smoking cessation in pregnancy, in particular for Indigen-
ous populations, is an example where multiple factors
have been identified that could be critical when designing
targeted approaches to smoking cessation [4, 12]. A lack
of evidence for successful smoking cessation interventions
for pregnant Indigenous populations highlights the im-
portance of understanding context when designing
intervention components, and using a systematic ap-
proach to avoid implementation challenges [5].
Evidence-based smoking cessation care
There is robust evidence that a combination of two ap-
proaches, the use of counselling and appropriate forms of
pharmacotherapy, produces better outcomes than each
alone in the general population of smokers [13]. Nicotine
replacement therapy (NRT) is the most appropriate type
of smoking cessation pharmacotherapy in pregnancy [14].
Emerging evidence from Cochrane Reviews indicates that
counselling and NRT are effective in pregnancy [5], al-
though these approaches have not yet been shown to be
efficacious in Indigenous pregnancies. However, only two
randomised controlled trials have been conducted globally
in Indigenous pregnant women [1517].
The Indigenous Counselling and Nicotine QUIT in
Pregnancy intervention
The Indigenous Counselling and Nicotine (ICAN) QUIT
in Pregnancy is an evidence-based smoking cessation
implementation intervention, developed primarily as a
training intervention for health providers through webi-
nar. It aims to support health providers to provide cul-
turally targeted smoking cessation care to pregnant
Indigenous smokers, attending Aboriginal Medical Ser-
vices. Resources were developed to aid the implementa-
tion of the provider-patient consultation process (to aid
counselling and provision of NRT) and included three 1-
h interactive webinar sessions with PowerPoint presenta-
tions and short embedded videos, a training manual, a
flipchart and a desktop guide (as a mouse pad). As part
of the implementation, pregnant patients were to be pro-
vided a combined educational and motivational booklet
with augmented reality videos within print media, and
an educational and motivational video that could be
watched in the clinic waiting room. Patient instructions
for NRT were included in the patient information book-
let by video and text. In addition, the implementation
intervention provided free samples of NRT, and free
courses of oral forms of NRT for the women to be pre-
scribed at the services, and audit and feedback for the
services about prescribing rates of NRT.
These resources developed through the process out-
lined below, went on to be reviewed by an expert panel
and tested in several focus groups with health providers
and Aboriginal women in three Australian states [18].
The resources then underwent a series of refinements
[18]. Throughout this iterative process, extensive con-
sultation and negotiation processes occurred, working
closely with Aboriginal Medical Services and a Stake-
holder and Consumer Aboriginal Advisory Panel [19].
In order to design the ICAN QUIT in Pregnancy im-
plementation intervention and to address previous
Gould et al. Implementation Science (2017) 12:114 Page 2 of 14
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implementation challenges (revealed by similar trials for
Indigenous women during pregnancy [1517]), the Be-
haviour Change Wheel (BCW) [20] and the Theoretical
Domains Framework (TDF) were used [21]. These
models were used to design a service-level approach,
which would address the evidence gaps and provide a
targeted approach for smoking cessation care at the
health provider (HP) and patient levels.
Underpinning models and frameworks
Behaviour Change Wheel
The BCW is a parsimonious model synthesising many
behaviour change theories (see Fig. 1) [20]. At its hub is
the COM-B model, which expands to capability (C), op-
portunity (O) and motivation (M)these are all needed
to produce or change a behaviour (B) [20]. The COM-B
model recognises that behaviour is part of an interacting
system involving an individuals or groups capability
(physical and psychological), opportunity (social and
physical) and motivation (reflective and automatic). A
mid ring on the BCW comprises nine intervention func-
tions, and on the outer ring, there are seven policy-level
strategies. The BCW is used to link influences on behav-
iour, identified by the COM-B, to potential intervention
functions and policy categories.
Theoretical Domains Framework
The TDF is an implementation science model compris-
ing 14 domains that can categorise influences on behav-
iour [21]. These include the following: Knowledge,
Skills,Social/Professional Role and Identity,Beliefs
about Capabilities,Optimism,Beliefs about Conse-
quences,Reinforcement,Intentions,Goals,Memory, At-
tention and Decision Processes,Environmental Context
and Resources,Social Influences,Emotionsand Behav-
ioural Regulation. According to Michie et al., links be-
tween the BCW and TDF can be utilised in the analysis
and design of targeted interventions [11].
The BCW and TDF have been used previously to ana-
lyse health provider and patient or consumer behaviour;
for example, Alexander et al. used the TDF and the COM-
B to analyse barriers to the use of the Healthy Kids Check,
introduced by the Australian Government in 2008 to
guide the health screening of pre-school children by GPs
and nurses [22]. Gould used the BCW to analyse barriers,
enablers and strategies to improve smoking cessation care
for pregnant Indigenous women [4].
The BCW is emerging as an important tool to rigor-
ously develop interventions prior to clinical trials. The
TDF and BCW have been used to systematically develop
complex interventions in other populations and for
other behaviours: several targeted health provider behav-
iour [2328]. Sinnott et al. used the BCW to develop an
intervention to improve medication management in
multimorbidity by GPs, by uniquely developing a collab-
orative shared decision-making approach between peers
[26]. McSharry et al. developed a multilevel intervention
to increase delivery of sexual health counselling by car-
diac rehabilitation staff [25]. Murphy et al. used the TDF
and BCW to develop a capacity-building program to en-
hance pharmacistsroles in mental health care [27]. The
latter focused on health provider training, using a train-
the-trainer approach. Similar to our approach, Murphy
et al. highlight the iterative and fluid nature of the devel-
opmental process, which is challenging to capture. Rele-
vant to our study, researchers applied the BCW and
COM-B model at both the provider and patient levels to
develop interventions to encourage long-term hearing
Fig. 1 The Behaviour Change Wheel (reproduced with permission from authors) [11]
Gould et al. Implementation Science (2017) 12:114 Page 3 of 14
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aid use [24] and to encourage nurse-led physical activity
in patients [21, 28]. More specifically for smoking cessa-
tion, for example, the BCW was used to develop a mo-
bile phone App to encourage patients to use UK Stop
Smoking Services, prior to a full trial of the intervention
[29], and an App to support smoking cessation among
pregnant women [30].
Indigenous-specific factors
In addition to the BCW and TDF, two factors appear to
be relevant for developing Indigenous-specific ap-
proaches related to tobacco control and smoking cessa-
tion. A factor analysis of 47 organisations developing
tobacco control messages for Indigenous Australians re-
vealed two important, yet separate factors of cultural
understandingand rigour. Aboriginal Medical Services
demonstrated strength in their cultural understanding
while universities and government organisations demon-
strated strength in rigour. A combination of cultural un-
derstanding and rigour was applied by few participating
organisations. However, these two important factors
emerging from the analysis can be seen as an opportun-
ity to bring the best of two worlds togetherIndigenous
and Western viewpoints [31].
Methods
Aim, design and setting
The aim of this study was to describe (1) how imple-
mentation and intervention components for the ICAN
QUIT in Pregnancy were developed for health provider
and patient behaviour change based on the TDF and
BCW and (2) comment on the translation of current evi-
dence from smoking cessation care during pregnancy in
conjunction with Indigenous researchers and an Abori-
ginal community advisory panel, and relevant to an Indi-
genous context.
This study was based on a growing body of evidence in-
cluding systematic reviews by Okoli et al. about the
provision of smoking cessation care by health providers
[9] and by Baxter et al. about the uptake of smoking cessa-
tion care by pregnant women [26, 32], which demon-
strated gaps in delivery of elements of SCC from the
provider and patient viewpoints, and a systematic review
by Gould et al. about Aboriginal womens views of smok-
ing during pregnancy [33]. Several narrative explorations
of the influences on smoking among Indigenous women
including two analyses using the BCW [2, 4, 34, 35], and
empirical studies from both health providersand Indigen-
ous womens views about knowledge, attitudes and prac-
tices, were considered [3640].
Materials and processes
We conducted further research to refine our under-
standing about practices from the health provider view
and the patientsviewpoints. Thus, we based our initial
intervention design on several studies. These included
the following:
1. A systematic review of knowledge, attitudes and
practices of health providers globally in providing
smoking cessation care for pregnant women. The
review, (currently being conducted) includes self-
report from the health providers, observational
studies and womens reports of the care they
received. Seventy-nine papers were included: 53
quantitative, 24 qualitative and 2 mixed methods.
A meta-analysis was performed of pooled estimates of
how often health providers perform each of the 5As
(Ask,Advise,Assess,Assist,Arrange), and pre-
scribing rates of NRT. Qualitative data was extracted
forananalysisofissuesregardingsmokingcessation
care and the use of NRT, according to the BCW and
COM-B, from the 24 qualitative and two mixed
methods paper.
2. A systematic review of 23 included papers about
interventions to improve health providerssmoking
cessation care for pregnant women, globally (in
process)
3. A survey of 378 general practitioners (GPs) and
obstetriciansknowledge, attitudes and practices
related to smoking cessation care for pregnant
women. This included an analysis using the TDF and
revealed several components of SCC that were less
than ideal or missing, for example assisting pregnant
women to quit and prescribing suitable forms of
pharmacotherapy [8]. (Results are summarised
below in the section on step 2 of the process.)
4. A qualitative study of 20 Aboriginal women who
were pregnant or had recently given birth and were
smoking or ex-smokers. The study focused on the
womens narratives of smoking before, during and
after pregnancy and their attitudes and experiences
of accepting smoking cessation care and pharmaco-
therapy [29,41,42].
Thus, we took into consideration multiple studies
on Indigenous pregnancy from researchers in this
field [12, 33, 36, 38, 39, 4346], identifying the fol-
lowing major factors:
Smoking by Indigenous women during pregnancy is
a complex challenge and has multiple contributing
factors.
Clinicians ask and advise about smoking but less
frequently assess, assist and arrange follow-up.
Clinicians report a lack of confidence and optimism
for helping their pregnant patients stop smoking.
NRT prescription rates are also low.
Gould et al. Implementation Science (2017) 12:114 Page 4 of 14
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Aboriginal pregnant women report deficiencies in
being provided important elements of smoking
cessation care, such as being prescribed NRT, and
being given consistent messages.
In the developmental phase of the implementation
intervention, we considered approaches to modify both
health provider behaviour, so that they more consistently
provide evidence-based smoking cessation care to Indi-
genous women, and Indigenous womens behaviour re-
garding their tobacco smoking practices during
pregnancy. The health providers of interest were those
working within the ACCHS in Australia. These included
GPs, midwives, nurses, Aboriginal Health Workers and
other relevant allied health professionals.
The research team was multidisciplinary and included
Aboriginal and non-Aboriginal researchers from med-
ical, social science, art, public health, behavioural science
and education backgrounds. The team developed the re-
sources collaboratively over several months and in con-
sultation with a Stakeholder and Consumer Aboriginal
Advisory Panel through a community-based participa-
tory action research process [19]. The process of the
intervention development, while guided by the stated
theoretical frameworks, was iterative and fluid and
evolved over several months of working within the core
research team and the broader group of stakeholders.
Use of the BCW and TDF by the research team
Using the BCW to translate the evidence into a cultur-
ally competent approach and guide the implementation
intervention design, we followed the three stages recom-
mended in Michie et al.sBehaviour Change Wheel
guide and associated worksheets [11]. Two of the team
(GG and YBZ) attended a BCW training course run by
the books author and our co-author (LA).
Figure 2 shows the schema of the three stages and the
composite steps in each, according to the BCW guide
[11].
Results
The results from this analysis are structured according to
the recommended stages and steps for intervention design,
as described by Michie et al., and designated in Fig. 2 [11].
Designing approach to health provider behaviour
change
Stage 1: understand the behaviour
Step 1: define problem in behavioural terms
A conceptual model (Fig. 3) depicts the multiple factors
that influence smoking behaviours and smoking cessa-
tion among Indigenous women [2, 4, 12, 3336, 3840,
42, 44, 4649]. These factors have an impact at the sys-
temic level, provider level and community and individual
levels. Although work is going on to attempt to remedi-
ate some of these factors (such as the policy-level lobby-
ing to improve access and affordability of oral forms of
NRT), this intervention is focused on translating the
evidence-based practice for SCC in pregnancy to the In-
digenous context.
Health provider behaviours
We identified the behavioural problem as a lack of es-
sential elements in the health providersprovision of
evidence-based SCC for pregnant Indigenous women
who smoke, such as prescribing NRT, providing cessa-
tion support, involving family members and following
up. Health providers are required to provide SCC to
pregnant women who smoke. The Australian RACGP
guidelines recommend initially using supportive counsel-
ling, but if the woman cannot quit, she can be also of-
fered NRT to assist cessation [50].
A systematic review by Okoli et al. [9] and our own
systematic review (Gould 2017, unpublished data) re-
vealed that while health providers often Askand Advise
about smoking cessation to pregnant women, they less
commonly Assistwomen to quit smoking. A lack of
support from health providers for smoking cessation
during pregnancy was cited as a barrier in previous re-
search, with Aboriginal women and other vulnerable
groups [41, 51].
The variety of health providers needing to improve ac-
cess to SCC within the ACCHS is manifold. Depending
on the stage of pregnancy, and the services themselves,
women will see several different health professionals.
We considered all health providers within a service
would need to have the same over-arching approach for
SCC, so the women would not receive conflicting advice.
Thus, a whole-of-service approach was considered.
Step 2: select the target behaviour
Several evidence-based practices are recommended for
SCC, including the 5As(Ask,Advise,Assess,Assistand
Arrange) [50], the ABC (Ask,Brief advice,Cessation)
[11] [52] and the AAR (Ask,Advise,Refer) [53]. Gould
et al. proposed that health providers should take a holis-
tic approach to SCC for pregnant Aboriginal women
and recommended using an ABCD approachA (Ask/
assess), B (Brief advice), C (Cessation), D (Discuss psy-
chosocial context) [43].
A survey of 378 GPs and obstetriciansknowledge, at-
titudes and practices related to SCC for pregnant women
revealed that clinicians seldom perform the 5As of
smoking cessation (19.6% always/often) [8]. While more
perform the AAR (49.2% always/often), there are few re-
ferral options for specialised services for pregnant
women, and many are not being referred or followed up.
Clinicians fairly reliably (over 75%) asked and advised
Gould et al. Implementation Science (2017) 12:114 Page 5 of 14
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about smoking cessation, but only a third actually assisted
pregnant women to achieve smoking cessation. Cessation
support was provided always by 33.6%; NRT was recom-
mended/prescribed always by 11.1% and never by 25.1%.
The TDF analysis revealed that lack of optimism, lack of
time and lack of resources were the most frequently cited
barriers [8].
Similarly, a survey specifically with health providers
working with Aboriginal pregnant mothers revealed that
only 4.7% recommended NRT to most or all pregnant
clients who smoked [40].
Furthermore, Aboriginal women in our qualitative
study revealed that they were seldom offered NRT, and
when an offer did occur, it was as a one-offoffering,
and the approach and messages were inconsistent [41].
Women reported they were often told to cut downtheir
smoking, but rarely supported to quit [41].
A review of this combined evidence led to a decision
to primarily target the behaviour of health providers in
offering NRT to assist smoking cessation. In other
settings, assisting smokers to quit by providing a pre-
scription of NRT was more effective than providing ad-
vice (RR 1.68, 95% CI 1.481.89 vs. RR 1.24, 95% CI
1.161.33) [41, 51]. A parallel target was to support the
provision of a holistic culturally competent approach,
taking into account the social determinants of health
and psychosocial factors related to continued smoking
during pregnancy, that is exemplified in the ABCD ap-
proach [43], and thus provide resources to target the pa-
tientsneeds also.
Step 3: specify the target behaviour
In specifying the target behaviour, the BCW guidebook
recommends consideration of Who, What, When,
Where, How often and with Whom. The target behav-
iour therefore would be for clinicians (Who) in the
ACCHS (Where) to proactively offer assistance to every
pregnant Indigenous smoker (Whom) to quit smoking
(What), initially by counselling, but importantly by offer-
ing NRT, if the woman was not able to achieve
Fig. 2 Stages and steps required to develop and implement an intervention according to the Behaviour Change Wheel. Adapted from Figure on
page 31, Behaviour Change Wheela guide to designing interventions (with permission from the authors) [11]
Fig. 3 Approaches to improve smoking cessation among pregnant Indigenous women
Gould et al. Implementation Science (2017) 12:114 Page 6 of 14
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abstinence in the first 23 days of a quit attempt
(When). This would ideally be on every occasion that a
smoker is seen (How often) until abstinence achieved.
Although some guidelines suggest women should try a
quit attempt unaided by pharmacotherapy for 2 weeks
prior to be offering NRT, we considered this inappropri-
ate in this context. It is notable that in Eades et al.s
RCT, women were asked to do this, and between the
second and third visits, there was a dramatic drop-off in
attendance from 70 to 30% of the cohort [15]. So as not
to lose momentum in the quit attempt, and in the con-
text of wanting women to quit as soon as possible in
pregnancy, an expedited use of NRT was favoured [54].
Step 4: identifying what needs to change
Table 1 summarises the key items that required remedi-
ating for health providers, by considering the BCW, the
COM-B model and the TDF. Key areas for performance
improvement included capability (psychological skills),
motivation (optimism) and opportunity (resources/time).
According to the BCW, for this to be successful, clini-
cians would be required to increase their psychological
capability, i.e. knowledge and skills, and reflective motiv-
ation, i.e. confidence and optimism, in how to prescribe
NRT for a pregnant Indigenous woman who smokes.
Lower levels of confidence for NRT prescribing, com-
pared to counselling, were revealed in our national study
[8]. Clinicians also reported low optimism that their
treatment would be effective [53]. Thus, providers need
to build both self-efficacy and response efficacy. Further-
more, as the preferred oral forms of NRT to use in preg-
nancy are not subsidised in Australia, health providers
require improvements in their physical opportunity to
provide care, i.e. access to oral NRT supplies, in order to
effectively prescribe [47]. Clinicians understanding that
these practices are routine in other countries (such as in
Australian guidelines and programs and in other coun-
tries) may help them improve their social opportunity.
Stage 2: identify intervention options
Step 1: intervention functions
Table 1 also outlines the intervention components devel-
oped for health providers according to the analysis. Inter-
vention functions which best met the APEASE
(Affordability, Practicability, Effectiveness and Cost-
effectiveness, Acceptability, Side effects/safety, Equity) cri-
teria were considered for inclusion [11]. APEASE is a cri-
terion for making context-based decisions on intervention
content. Clinicians in our survey indicated several options
to improve their smoking cessation care (Gould 2017, un-
published). Training was an option that most of these cli-
nicians agreed on. This is supported by a Cochrane
Review that found training of HPs in smoking cessation
care increased abstinence in their patients [55]. Therefore,
education and training were chosen as the predominant
intervention function. However, to address the low opti-
mism, we include persuasion, modelling and enablement
in the intervention. Resources were also developed for the
women to support health providers in their consultations,
and to provide resources for health education, and prac-
tical assistance for their patients (described below).
Step 2: policy categories
On the policy layer of the wheel, service provision and
guidelines were our main policy targets. We wanted to
aim our approach to the whole of the ACCHS, in recogni-
tion that many health providers and allied health profes-
sions have a role in consulting with Indigenous women
during their pregnancy. We wanted smoking cessation to
be everyonesbusiness. Furthermore, we developed a
comprehensive treatment manual that gave very practical
guidance for the approach, based on the published prag-
matic guide and the RACGP guidelines [43, 50, 56].
Stage 3: identifying content and implementation options
Step 1: behaviour change techniques
Table 1 also specifies the behaviour change techniques
(BCTs) related to the above analysis and to address each
intervention function. A taxonomy of BCTs was devel-
oped by Michie et al. (BCTTv1) as a comprehensive re-
source for intervention development [57]. Each of the 93
consensually agreed, distinct BCTs in the taxonomy are
catalogued and described in detail. The BCTs identified
for the ICAN QUIT in Pregnancy implementation inter-
vention were those which authors considered as promis-
ing to elicit behaviour change in the health providers.
In summary, to implement this smoking cessation
intervention optimally, we aimed to improve capability
by training clinicians in NRT prescribing, structuring the
consultation using a flipchart and prompts and regulat-
ing behaviour through audit and feedback (allowing so-
cial opportunity). To improve optimism, in the training,
we present recent evidence about NRT and positive tes-
timonials from patients and clinicians. We recognised
that individual clinicians may not have experienced
intervention success but needed to be exposed to that
success vicariously through others testimonials, so they
see that success is possible and worthwhile persisting for
(response efficacy).
Step 2: mode of delivery
To accommodate challenges around time for health pro-
viders, the large geographical area of Australia and the lim-
ited resources of the research, we decided to trial training
via interactive webinar. Webinar was chosen as a mode of
delivery with the potential to increase the reach of health
provider training to urban, rural and remote locations in
Australiaandimprovethepotential scalability. Although
Gould et al. Implementation Science (2017) 12:114 Page 7 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
webinar is now a very common method of distance train-
ing, there is little research in the peer-reviewed literature
about the efficacy or effectiveness of this method. However,
we considered webinars to be affordable, cost-effective, safe,
likely to be acceptable and highly equitable. They give the
potential for face-to-face contact.
Training of short duration (40 to 120 min) has been
shown to increase smoking session outcomes in patient
Table 1 Intervention components targeting health provider behaviour
Barriers to smoking
cessation care
COM-B TDF Intervention
function
BCTs Translation of BCTs
within the ICAN QUIT in
Pregnancy intervention
Clinicians infrequently
provide cessation support
during pregnancy.
Clinicians lack knowledge,
skills and confidence to
counsel women who smoke
during pregnancy and to
prescribe NRT.
Lack of clinician training
relevant to smoking cessation during
pregnancy
Women report infrequently
receiving assistance from
clinicians
Psychological
capability
Cognitive and
interpersonal skills
Education
Training
Enablement
Information on health, social,
emotional and environmental
consequences
Information antecedents
Instruction on how to perform
behaviour
Webinar training on how
to consult Indigenous
pregnant smokers and
prescribe NRT
Training manual
Videos of providers and
patients
Memory, attention
and decision
Environmental
restructuring
Restructuring physical
environment
Prompts, cues
Flipchart and desktop
guide
Patient resources
Behaviour
regulation
Modelling
Incentivisation
Demonstration of behaviour
Feedback on behaviour
Rewarding completion
Audit and feedback
about
NRT prescribed
CPD points for training
Clinicians lack optimism
that their treatment will
be successful during
pregnancy
Reflective
motivation
Belief about
capability
Belief about
consequences
Optimism
Education
Training
Persuasion
Enablement
Information on health, social,
emotional and environmental
consequences
Credible source
Persuasion about capability
Framing/reframing
Salience of consequences
Social comparison
Adding objects to the
environment
Provide resources
Smoking reframed as an
addiction, not a choice
Inform re standard
practices and evidence-
based practices
Building self-efficacy
Build response
efficacyit is
worthwhileNNT only
1617 for quitting
Motivational videos,
testimonials and success
stories
Celebrating small wins
and turning near misses
into success
Automatic
motivation
Reinforcement
Emotion
Environmental
restructuring
Persuasion
Credible source
Exposure
Framing/reframing
Social comparison
Provide resources
Emotive videos of health
providers and patients
Clinicians lack time and
resources to provide
smoking cessation care.
Oral NRT is not subsidised in
Australia forming a barrier to
prescribing
Physical
opportunity
Environmental
context
Resources
Environmental
restructuring
Enablement
Adding objects to the
environment
Problem solving
Self-monitoring of behaviour
Free NRT samples and
oral NRT vouchers
Referral pads
Flipchart and desktop
guide
Patient booklets
Few clinicians perform
comprehensive smoking
cessation care so there are
few role models
Social
opportunity
Norms
Social influences
Modelling
Education
and training
Social comparison
Credible source
Instruction on how to perform
behaviour
Self-monitoring of behaviour
Whole of service training
Interactive webinar
Audit and feedback
Videos of positive
attitudes of other health
providers
Please note: physical capability not targeted; BCT behaviour change technique; COM-B capability, opportunity, motivation-behaviour; ICAN QUIT in Pregnancy Indi-
genous Counselling and Nicotine QUIT in Pregnancy
Gould et al. Implementation Science (2017) 12:114 Page 8 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
outcomes in a Cochrane Review [55]. Thus, three 1-h
webinar sessions were planned to bring the opportunity
of training to services and accommodate time and loca-
tion constraints, which may otherwise limit attendance
by the health providers. Webinar sessions were to be
interactive and include PowerPoint presentations, short
videos and group discussions. These went on to be
trialled in the pilot study in six services in three
states [58].
Design approach to patient resources
A parallel analysis was conducted to that described
above for the health providers, to address behaviour
change for pregnant patients. It was considered import-
ant to provide accompanying patient resources to sup-
port Indigenous women in their smoking cessation
journey that would also accommodate variable literacy
levels in this population. A lack of resources was also
identified by health providers. Similar to Table 1 for the
health providers, Table 2 outlines the intervention com-
ponents and behaviour change techniques we developed
for the pregnant patients who smoke, according to the
parallel analysis.
In developing the appropriate messages within the
womens resources, we deliberately included elements of
both surface and deep structure to ensure cultural sensi-
tivity. Resnicow et al. proposed that for health messages
to be effective and culturally sensitive [59], attention
should be paid to surface structure, i.e. the look of the
messages, colours, graphics and people to enable a good
fit, and so people from a group will be engaged and
know the message is for them. Additionally, deep struc-
ture is needed to incorporate the deeper values of a
group, such as cultural and family values, and important
shared concerns and meanings: this governs the salience
of the messages [59]. In a survey of Australian organisa-
tions developing tobacco control messages, deep struc-
ture was an important factor in cultural understanding,
the use of which was characterised by Aboriginal Med-
ical Services [31].
Having salient people to deliver the messages was vital,
so we invited an Aboriginal obstetrician (Dr. Marilyn
Clarke) and a Torres Strait Islander GP (Dr. Karen
Nicholls) to deliver the health messages. Dr. Clarke ex-
plains how smoking affects babies in utero, and Dr.
Nicholls instructs women on how to correctly use vari-
ous forms of NRT. In addition, we included videos from
peers about triggers for smoking and how to make a
smoke-free home.
Discussion
This study described the developmental and translational
research to identify key components for a culturally com-
petent smoking cessation implementation intervention
aimed at educating and training health providers and pro-
viding resources to support Indigenous women to quit
smoking and support making a smoke-free home. The
BCW has been used previously to analyse and recom-
mend targeted strategies [4, 35]. We provided a more de-
tailed analysis of the theoretical components for a
smoking cessation implementation intervention for preg-
nant Indigenous Australian women, than hitherto pub-
lished, aimed principally at changing health provider
behaviour. Patten developed a smoking cessation inter-
vention for pregnant Alaska Native women after analysing
community needs and preferences and based on the social
cognitive theoretical framework [17]. Gilligan conducted
an analysis of Indigenous smoking during pregnancy with
the PRECEED-PROCEED model [60], prior to Eades et al.
consulting with general practitioners, health care workers
and community representatives in the health services to
develop an intensive intervention for pregnant Aboriginal
and Torres Strait Islander smokers [15]. Neither study
published a detailed analysis about the theoretical frame-
work used to develop the intervention.
Several papers have outlined how to optimise smoking
cessation interventions aimed at vulnerable target
groups [2, 12, 43, 48, 49, 51, 6164]. For other condi-
tions, there has been discussion on theory informing the
development of Indigenous health programs. In an ana-
lysis of the development of anti-tobacco messages for In-
digenous Australians, 55% (n= 26) of organisations
reported using some type of theory, as one component
of a more rigorous approach [31]. However, we believe
this is the first time the BCW and TDF have been ap-
plied to the context of an Indigenous smoking cessation
implementation intervention.
The benefit of using the BCW is that it encourages
intervention designers, like us, to comprehensively and
broadly consider options to intervene and then systemat-
ically select those that are most promising for the con-
text. It aids in making the best use of the understanding
and resources available to arrive at a behaviour change
intervention [65].
Strengths and limitations
This study strengthens the theoretical foundations on
which to develop smoking cessation implementation in-
terventions for Indigenous peoples. It brings together
two important factors of cultural understanding and
rigour [31] and applies the TDF and the BCW to the
context of Indigenous smoking during pregnancy. A
limitation is the iterative nature of the process: it is hard
to capture the stepwise approach described by Michie et
al. as it can be bi-directional at times, and resulting con-
sultations within and without the core team meant that
earlier stages may be revisited, and these may not be
clearly documented. However, the Indigenous
Gould et al. Implementation Science (2017) 12:114 Page 9 of 14
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Table 2 Intervention components targeting patient behaviour
Barriers to smoking cessation care COM-B TDF Intervention
function
BCTs Translation of BCTs within the ICAN QUIT in
Pregnancy intervention
Indigenous pregnant women report symptoms of nicotine
dependence and withdrawal effects from attempts to quit.
Increased nicotine metabolism in pregnancy can increase
cigarette consumption and also requires higher doses of NRT
Physical
capability
Physical skills Education
Enablement
Provide feedback on current
behaviour and dependence levels
Assess withdrawal symptoms
Biofeedback with carbon monoxide
readings
Making a quit plan and/or setting
quit date
Advise on stop-smoking medication
Enable clients to obtain free
medication
Free NRT for physical addiction
Videos on how to use different types of NRT
Aboriginal women lack detailed knowledge about the harms
of smoking.
Stressful life circumstances may also impact on a womens
psychological capability to quit.
Historical antecedents of smoking in Indigenous communities,
racism, health disparities and low socio-economic status can
impair capability to quit
Psychological
capability
Knowledge Education Provide information on
consequences of smoking and
smoking cessation
Instruction on how to quit smoking
Offer appropriate written materials
Health booklet, supportive counselling and
videos showing effects of smoking on
mother and child
Discuss psychosocial contexts of smoking
Cognitive and
interpersonal
skills
Persuasion Facilitate goal setting
Facilitate barrier identification
and problem solving
Facilitate relapse prevention
and coping
Facilitate action planning and
develop quit plan
Advise on conserving mental
resources
Discussion of psychosocial context of
smoking
Build self-efficacy for quitting
Culturally appropriate colouring-in pages
for diversion and relaxation
Memory,
attention and
decision
Environmental
restructuring
Enablement
Advise on avoiding social cues
for smoking
Elicit client views
Provide reassurance
Text and video on how to make a smoke-free
home
Personalised quit plan and goal setting
Patient resources
Behaviour
regulation
Enablement
Modelling
Messages from salient otherspeers and
experts
NRT to reduce withdrawal effects
Carbon monoxide readings
Videos of role models
Counselling on stressors and triggers
Few positive role models, as Indigenous smoking
prevalence is high
Targeted messages preferred
Existing media messages may lack salience.
Not wanting to be told what to do.
Didactic counselling styles are unwelcome
Reflective
motivation
Social role/
identity
Belief about
capability
Belief about
consequences
Intentions
Goals
Optimism
Persuasion
Education
Enablement
Incentivisation
Modelling
Credible sources for messages
Explain the importance of abrupt
cessation
Boost motivation and self-efficacy
Rewards contingent on effort or
progress
Emphasise choice
Targeted salient messages
Build self-efficacy
Building response efficacystopping
smoking is worthwhile
Smoking as an addiction
Link nicotine withdrawal and symptoms
of stress
Emphasising choice to quit
Resources and support
Success stories and role models via videos
Goal setting, quit plan and quit date
Gould et al. Implementation Science (2017) 12:114 Page 10 of 14
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Table 2 Intervention components targeting patient behaviour (Continued)
Dealing with challenges
Change of role on becoming pregnancy
positively reinforces need to quit.
Protective attitudes to baby
Cravings can impair motivation
Automatic
motivation
Reinforcement Self-rewards in quit plan
Celebrating small wins
Free NRT ameliorates withdrawal symptoms
Lack of optimism for quitting Emotion Environmental
restructuring
Persuasion
Enablement
Addressing challenges in quit plan
Emotive videos
Free NRT ameliorates withdrawal/stress
symptoms
Lack of access to services or presenting late
to antenatal care
Lack of targeted resources
Lack of subsidised NRT
Health providers not frequently offering assistance
to quit
Physical
opportunity
Environmental
context
Resources
Environmental
restructuring
Enablement
Education
Advise on environmental
restructuring
Advise on changing routine
Trained providers to support their quit
attempts
Referrals to other services
Flipchart
Patient booklets
Few role models who have quit during pregnancy Social
opportunity
Social
influences
Modelling Provide normative information
about othersbehaviour and
experiences
Advise on/facilitate use of social
support
Involving family members
Making a smoke-free home
Increasing social support
Positive peer role models through
video stories
BCT behaviour change technique; COM-B capability, opportunity, motivation-behaviour; ICAN QUIT in Pregnancy Indigenous Counselling and Nicotine QUIT in Pregnancy
Gould et al. Implementation Science (2017) 12:114 Page 11 of 14
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
consultation and community-based participatory research
process have been described in detail elsewhere [19]. The
implementation intervention of the ICAN QUIT in Preg-
nancy will be tested in the pilot study and be adjusted as
required [58].
Implications for future research
These chosen intervention functions, mode of delivery
and resources are in the process of being trialled for
feasibility in a pilot study in six ACCHS, prior to it be-
ing implemented in a full trial [58, 66]. After this pilot
study, end-users will be surveyed and interviewed to
determine whether the intervention and study design
need any modifications before preparing for a larger
cluster randomised trial (renamed SISTAQUITSup-
porting Indigenous Smokers To Assist Quitting). The
systematic approach for the intervention development
we have described will help streamline this process.
Conclusion
Smoking during pregnancy contributes significantly to the
health gap for Indigenous Australians. Multiple contribut-
ing factors impact at systemic, provider, community and
individual levels. The ICAN QUIT in Pregnancy pilot im-
plementation intervention used webinar to train health
providers in Aboriginal Medical Services in a culturally
competent approach that includes counselling and the use
of nicotine replacement therapy for their pregnant pa-
tients who smoke. It includes culturally targeted resources
appealing to Indigenous women that can engage and also
account for low literacy by including embedded videos in
print media. Using the BCW and TDF aided in scientific-
ally and systematically informing a targeted intervention
based on the identified gaps in SCC by health providers.
This process was important for defining the design and
intervention components, prior to conducting a pilot
feasibility trial and then leading on to a full clinical trial.
Abbreviations
BCT: Behaviour change technique; BCW: Behaviour Change Wheel; COM-
B: Capability, opportunity, motivation, behaviour; GP: General practitioner;
ICAN QUIT in Pregnancy: Indigenous Counselling and Nicotine QUIT in
Pregnancy; NRT: Nicotine replacement therapy; RACGP: Royal Australian
College of General Practitioners; RCT: Randomised controlled trial;
SCC: Smoking cessation care; TDF: Theoretical Domains Framework
Acknowledgements
The authors thank the Stakeholder and Consumer Aboriginal Advisory Panel
for the ICAN QUIT in Pregnancy for advising on the intervention
components of this implementation intervention.
Funding
This work was funded by the Australian National Health and Medical
Research Council and Cancer Institute New South Wales Fellowships
awarded to GG. The funders had no role in the design of the study or
collection, analysis and interpretation of data or in the writing of the
manuscript.
Availability of data and materials
Not applicable.
Authorscontributions
GG designed the study, conducted the analysis, led the design of the
intervention components, and wrote the manuscript. YBZ contributed to the
analysis, the design of the intervention components, and the structure of the
paper. LA advised on the analysis of the intervention components and the
structure of the paper and provided training for GG and YBZ on the BCW.
MB contributed to designing intervention components and, together with
MG and MC, contributed Aboriginal cultural advice about the intervention
components. BB critically reviewed the paper and contributed to the design
of intervention components. All authors read and approved the final
manuscript.
Ethics approval and consent to participate
Not applicable for the design aspects of this study.
Consent for publication
Not applicable.
Competing interests
YBZ has received fees for lectures in the past (years 20122015) from
Novartis NCH (distributes NRT in Israel). She has not received any fees from
pharmaceutical companies in Australia. No other authors have competing
interests to declare.
PublishersNote
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.
Author details
1
School of Medicine and Public Health, University of Newcastle, University
Drive, Callaghan, NSW 2308, Australia.
2
University College London, 1-19
Torrington Place, London WC1E 7HB, UK.
3
Clarence Specialist Clinic, 86
Through Street, South Grafton, NSW 2460, Australia.
Received: 13 July 2017 Accepted: 7 September 2017
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... The identified TMFs and their application in health intervention implementation are summarised in Table 2. Nine of the TMFs were novel and had an equity focus [57][58][59][60][61][62][63][64][65], three were equity-focused adaptations of established TMFs [11,66,67], and three were established TMFs applied in an equity context [68][69][70][71][72][73][74]. Five of the novel TMFs were developed in the USA [57,60,63,64,66]: one each in Australia [62], Aotearoa New Zealand [61], Latin America [58], Canada and Tanzania [59]. ...
... The COM-B model describes the behavioural aspects of implementation across three domains: Capability, Opportunity and Motivation [72]. COM-B is not equityfocused but has been used to adapt a gestational diabetes programme for Latina women [72] and to design a smoking cessation service for Aboriginal and Torres Straight Islander people in Australia [73]. COM-B is primarily focused on individual-level behaviours. ...
... Determinant framework (n = 4) Consolidated Framework for Implementation Research (CFIR) [68][69][70][71] Health Equity Implementation Framework (HEIF) [66] He Pikinga Waiora Implementation Framework (HPW) [61] Integrated PRISM and SEM framework [65] Implementation theory (n = 1) Capability, Opportunity, Motivation and Behaviour (COM-B) model [72,73] Process model (n = 6) Equity-based Framework for Implementation Research (EquIR) [58] Intervention and Research Readiness Engagement and Assessment of Community Health Care (I-RREACH) [59] Transcreation Framework [60] Collaborative Intervention Planning Framework [64,84] ConNECT Framework [57] Indigenous Health Promotion Tool Implementation Model [62] Evaluation framework (n = 3) Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) [74] Extension of RE-AIM for sustainability [67] Adaptation of Proctor et al. [11] Hybrid (n = 1) EQ-DI [63] practical guidance about how to plan and carry out implementation activities [42]. The remaining two TMFs provide a description of equity-focused implementation but with less distinct steps or phases [57,62]. ...
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Background Inequities in implementation contribute to the unequal benefit of health interventions between groups of people with differing levels of advantage in society. Implementation science theories, models and frameworks (TMFs) provide a theoretical basis for understanding the multi-level factors that influence implementation outcomes and are used to guide implementation processes. This study aimed to identify and analyse TMFs that have an equity focus or have been used to implement interventions in populations who experience ethnicity or ‘race’-related health inequities. Methods A scoping review was conducted to identify the relevant literature published from January 2011 to April 2022 by searching electronic databases (MEDLINE and CINAHL), the Dissemination and Implementation model database, hand-searching key journals and searching the reference lists and citations of studies that met the inclusion criteria. Titles, abstracts and full-text articles were screened independently by at least two researchers. Data were extracted from studies meeting the inclusion criteria, including the study characteristics, TMF description and operationalisation. TMFs were categorised as determinant frameworks, classic theories, implementation theories, process models and evaluation frameworks according to their overarching aim and described with respect to how equity and system-level factors influencing implementation were incorporated. Results Database searches yielded 610 results, 70 of which were eligible for full-text review, and 18 met the inclusion criteria. A further eight publications were identified from additional sources. In total, 26 papers describing 15 TMFs and their operationalisation were included. Categorisation resulted in four determinant frameworks, one implementation theory, six process models and three evaluation frameworks. One framework included elements of determinant, process and evaluation TMFs and was therefore classified as a ‘hybrid’ framework. TMFs varied in their equity and systems focus. Twelve TMFs had an equity focus and three were established TMFs applied in an equity context. All TMFs at least partially considered systems-level factors, with five fully considering macro-, meso- and micro-level influences on equity and implementation. Conclusions This scoping review identifies and summarises the implementation science TMFs available to support equity-focused implementation. This review may be used as a resource to guide TMF selection and illustrate how TMFs have been utilised in equity-focused implementation activities.
... [25][26][27] Both are validated and integrative models of behavior change and have been applied across a wide scope of clinical situations. 28 The survey was reviewed by five experienced public health researchers who specialize in survey development. Subsequently, it was pretested with eight dietitians who work with different populations and have various clinical proficiencies. ...
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Background The health and environmental benefits of legume consumption are reflected in dietary guidelines worldwide. However, legume intake fails to meet recommendations. Dietitians’ legume counseling practices can impact consumption patterns. This cross-sectional study assessed Israeli dietitians’ knowledge, attitudes, perceptions and practices regarding legume counseling and identified pertinent barriers and facilitators. Methods An electronic survey among Israeli dietitians (n = 309) was performed. Multivariable logistic regression assessed associations between recommending legumes with participants’ socio-demographic and professional characteristics, knowledge, perceptions, attitudes toward legume counseling and personal legume intake. Results Almost half (47.4%) of the participants recommended that 76% or more of their patients increase legume intake. Factors that were associated with recommending legumes were perceptions of fewer barriers to consumption [adjusted OR (aOR) 1.92 (95% CI 1.24–2.96)] and positive attitudes toward legume counseling pertaining to its importance [aOR 1.95 (95% CI 1.12–3.4)]. Negatively associated factors were a low level of personal legume consumption [aOR 0.38 (95% CI 0.15–0.94)] and working in hospitals [aOR 0.43 (95% CI 0.19–0.98)]. Conclusions Israeli dietitians’ recommendations for legume consumption were well below current guidelines. These findings indicate the need for a tailored intervention for nutrition professionals to increase the frequency of legume counseling and overall consumption.
... A number of participants utilized models such as COM-B, a behaviour system which proposes that behaviour is generated by three components: capability, motivation, and opportunity; with a range of potential influences between components in the system (Michie et al., 2011). HBC approaches have been extensively utilized in the development and human health sectors (Carney et al., 2016;Gould et al., 2017;Michie et al., 2011) and participants described their flexibility to be applied and adapted to different contexts. ''I would say, and this is more from the development and humanitarian sectors, is that increasingly what is being seen as replicable is not the product but the process. ...
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Plain Language Summary Sustainability in NGO Programming The sustainability of NGO initiatives has become an aspect on which the success of programming is judged. This study explores the conditions needed to achieve sustainable change by focusing on a sector that has recently experienced a shift towards more sustainable, interdisciplinary programming: that of working equine (animal welfare) NGOs. Semi-structured, in-depth interviews with 32 NGO staff working for 8 different animal welfare NGOs across 13 countries were conducted. These interviews covered potential barriers and avenues to success in producing sustainable working animal welfare improvements. Thematic analysis revealed consistent themes across contexts and organizations. Approaches perceived as creating sustainable outcomes were ones that tailored initiatives to local contexts, focused on changing human behaviour, worked with key community contacts, built capacity in local infrastructure, combined approaches and had comprehensive exit strategies. Barriers to sustainability included lack of continuity, short funding cycles and unpredictable external factors. Consideration of these conditions for designing effective future initiatives is recommended across the wider not-for-profit sector.
... Personalization of medication reminders is critical to meeting individual patient needs (Friedman et al., 2015). Systems that allow patients to adjust reminders according to their schedules and preferences increase the likelihood of adherence (Gould et al., 2018). Flexibility in these systems is crucial to accommodate the complexities of prescribed drug regimens. ...
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This study investigated the effectiveness of an innovative application for the management of prescription medications, focusing on patients adherence to treatment. Using a methodological approach based on the SCRUM framework, we developed an app that allowed patients to record their prescriptions and receive personalized reminders for medication administration. The results demonstrated an average treatment adherence of 91%, indicating the effectiveness of the app in improving patient compliance. We looked at different age groups and types of medication, highlighting the importance of personalization in promoting adherence. This study contributes not only to the understanding of treatment adherence, but also offers practical insights for healthcare professionals and app developers interested in improving medication management.
... In this study, our desired behavior change for the clinical team is to deliver the SPI using the Hope app on patients' own devices. The BCW and TDF have been used in a wide range of disciplines such as health promotion [84][85][86][87] and health informatics [88][89][90] to characterize barriers to and facilitators of implementation. For example, in the field of health informatics, the BCW and TDF have been used to inform implementation strategies to facilitate the completion of electronic discharge summaries [90]. ...
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Background Suicide prevention is currently a national health priority in Canada. Emergency departments (EDs) are critical settings for suicide prevention, and in our local psychiatric ED at the Centre for Addiction and Mental Health, we plan to embed an app-based tool called the Hope app to support suicide safety planning intervention. The app is free and available on app stores, and usability tests have been completed. As a next step to embed this new tool into the routine clinical workflow, research is needed to assess determinants of and design strategies for implementation with the end goal of routinization. Objective The purpose of this 2-phased research is to implement the app in the routine clinical workflow in our local psychiatric ED. The specific objectives are as follows: (1) understanding ED clinicians’ perceptions and experience of implementing the app in routine practice and identifying barriers to and facilitators of implementation (phase 1) and (2) using findings and outputs from phase 1 and collaborating with service users, families, and ED clinicians to co-design implementation strategies for the app (phase 2). Methods We will use an integrated knowledge translation approach throughout this project. In phase 1, we will conduct interviews with ED clinicians to identify implementation determinants using a behavior change framework. In phase 2, a co-design team comprising clinicians, ED service users, and families will design implementation strategies that align with the determinants identified in phase 1. Results This protocol presents detailed information about the entire structure of the 2-phased research project. Ethics approval for conducting the qualitative descriptive study (phase 1) has been obtained, and the recruitment and data collection processes will be completed no later than December 2023. Ethics approval for phase 2 is underway. Conclusions Involving multiple knowledge user groups early in the research and decision-making process is crucial for successful implementation. Although co-designing is commonly practiced during innovation development, there is often a misconception that the responsibility for implementing what has been designed falls on others. This research aims to fill this methodological gap in the health informatics literature. By the end of this project, we will have developed theory-informed implementation strategies to support Centre for Addiction and Mental Health ED clinicians in adopting the Hope app to complete safety planning intervention. These strategies, guided by a behavior change framework, will target clinicians’ behavior change and seamlessly integrate the app into the routine clinical workflow. In addition, this research project will provide recommendations on how to involve multiple knowledge user groups and offer insights into how the methodology used can be adapted to other areas within the health informatics literature. International Registered Report Identifier (IRRID) PRR1-10.2196/50643
... The BCW is an increasingly applied framework for designing and developing behavior change interventions in various health-related problems and contexts [39][40][41][42] (some interventions were delivered through apps [43][44][45][46]). However, to the best of our knowledge, the BCW has never been used in the context of supporting pain self-management for patients with cancer. ...
Article
Full-text available
Background To inform the development of an intervention, it is essential to have a well-developed theoretical understanding of how an intervention causes change, as stated in the UK Medical Research Council guidelines for developing complex interventions. Theoretical foundations are often ignored in the development of mobile health apps intended to support pain self-management for patients with cancer. Objective This study aims to systematically set a theory- and evidence-driven design for a pain self-management app and specify the app’s active features. Methods The Behavior Change Wheel (BCW) framework, a step-by-step theoretical approach to the development of interventions, was adopted to achieve the aim of this study. This started by understanding and identifying sources of behavior that could be targeted to support better pain management. Ultimately, the application of the BCW framework guided the identification of the active contents of the app, which were characterized using the Behavior Change Technique Taxonomy version 1. Results The theoretical analysis revealed that patients may have deficits in their capability, opportunity, and motivation that prevent them from performing pain self-management. The app needs to use education, persuasion, training, and enablement intervention functions because, based on the analysis, they were found the most likely to address the specified factors. Eighteen behavior change techniques were selected to describe precisely how the intervention functions can be presented to induce the desired change regarding the intervention context. In other words, they were selected to form the active contents of the app, potentially reducing barriers and serving to support patients in the self-management of pain while using the app. Conclusions This study fully reports the design and development of a pain self-management app underpinned by theory and evidence and intended for patients with cancer. It provides a model example of the BCW framework application for health app development. The work presented in this study is the first systematic theory- and evidence-driven design for a pain app for patients with cancer. This systematic approach can support clarity in evaluating the intervention’s underlying mechanisms and support future replication.
... The BCW is an increasingly applied framework for designing and developing behavior change interventions in various health-related problems and contexts [39][40][41][42] (some interventions were delivered through apps [43][44][45][46]). However, to the best of our knowledge, the BCW has never been used in the context of supporting pain self-management for patients with cancer. ...
Preprint
Full-text available
BACKGROUND To inform the development of an intervention, it is essential to have a well-developed theoretical understanding of how an intervention causes change, as stated in the UK Medical Research Council guidelines for developing complex interventions. Theoretical foundations are often ignored in the development of mobile health apps intended to support pain self-management for patients with cancer. OBJECTIVE This study aims to systematically set a theory- and evidence-driven design for a pain self-management app and specify the app’s active features. METHODS The Behavior Change Wheel (BCW) framework, a step-by-step theoretical approach to the development of interventions, was adopted to achieve the aim of this study. This started by understanding and identifying sources of behavior that could be targeted to support better pain management. Ultimately, the application of the BCW framework guided the identification of the active contents of the app, which were characterized using the Behavior Change Technique Taxonomy version 1. RESULTS The theoretical analysis revealed that patients may have deficits in their capability, opportunity, and motivation that prevent them from performing pain self-management. The app needs to use education, persuasion, training, and enablement intervention functions because, based on the analysis, they were found the most likely to address the specified factors. Eighteen behavior change techniques were selected to describe precisely how the intervention functions can be presented to induce the desired change regarding the intervention context. In other words, they were selected to form the active contents of the app, potentially reducing barriers and serving to support patients in the self-management of pain while using the app. CONCLUSIONS This study fully reports the design and development of a pain self-management app underpinned by theory and evidence and intended for patients with cancer. It provides a model example of the BCW framework application for health app development. The work presented in this study is the first systematic theory- and evidence-driven design for a pain app for patients with cancer. This systematic approach can support clarity in evaluating the intervention’s underlying mechanisms and support future replication. CLINICALTRIAL
Article
Few interventions to support smoking cessation include content specifically about diabetes. This is problematic, as people with diabetes face unique challenges when they stop smoking. The purpose of this study was to understand patients' needs and challenges in relation to smoking with Type 2 diabetes and assess the acceptability of a text message intervention to support smoking cessation. People who smoke and have Type 2 diabetes in the United States and the United Kingdom were recruited to participate in semistructured interviews ( n = 20), guided by the Capability, Opportunity, Motivation, and Behavior model. A combination of inductive and deductive approaches with framework analysis was used to analyze the data. Results indicated that the participants' experiences related to the constructs of the Capability, Opportunity, Motivation, and Behavior model and the categories of mental health and diabetes distress were also notable parts of their experiences. Results can be used to guide intervention development in this unique group.
Preprint
Full-text available
Background The 5A’s model for brief smoking cessation care (SCC) is recommended for dentists to reduce the negative impacts of smoking on oral health. This study investigates Israeli dentists' adherence to the 5A’s guidelines and explores factors influencing their knowledge, attitudes, and practices. Methods An online cross-sectional survey was conducted among Israeli dentists during June-August 2020. The questionnaire included sociodemographic, smoking, and professional characteristics; knowledge (10 true/false statements); attitudes regarding SCC (based on the Theoretical Domains Framework (TDF)) using 13 statements (1–5 Likert scale), for a composite mean attitude score; and 5A’s performance (1–5 Likert scale, never to always). Two primary outcomes were analysed: 1) performing all of the 5A’s ‘often or always’; and 2) performing ‘always’ the first two steps (“Ask” and “Advise”). Multivariable logistic regression explored the association between the various characteristics and the primary outcomes. Results Overall, n = 410 responded. Mean knowledge score was 2.58 (SD = 1.51). Mean attitude score was 2.65 (SD = 0.60). Performance of all 5A’s was low with 14.1% (n = 57) reporting completing all 5A’s ‘often or always’, while 34.1% (n = 139) reported ‘always’ performing ‘Ask’ and ‘Advise’. Specialists had better odds of ‘often or always’ performing the 5A’s (adjusted OR = 2.01, p = .022) and ‘always’ performing ‘Ask and Advise’ (adjusted OR = 1.71, p = .022). Conclusions This study highlights the insufficient performance of SCC among Israeli dentists, revealing gaps in knowledge and attitudes related to SCC. Various measures, such as training, automatic referral systems, and integrating SCC as quality measures, may improve SCC provision among Israeli dentists.
Article
Full-text available
The nursing home population is characterized by multimorbidity and disabilities, which often result in extensive prescription of medication and subsequent polypharmacy. Deprescribing, a planned and supervised process of dose reduction or total cessation of medication, is a solution to combat this. This study aimed to identify barriers and enablers of deprescribing as experienced by nursing home physicians (NHPs) and collaborating pharmacists in the specific nursing home setting. This qualitative study utilized a semi-structured interview format with two focus groups consisting of a mix of NHPs and pharmacists. Directed content analysis was performed based on the Theoretical Domains Framework, a validated framework for understanding determinants of behavior change among health care professionals. Sixteen health care professionals participated in two focus groups, including 13 NHPs and three pharmacists. The participating NHPs and pharmacists believed that deprescribing is a valuable process with enablers, such as multidisciplinary collaboration, good communication with patients and family, and involvement of the nursing staff. NHPs and pharmacists view deprescribing as a core task and feel assured in their ability to carry it out successfully. However, they also noted barriers: deprescribing is time-consuming; communication with residents, their relatives or medical specialists is difficult; and electronic patient systems often do not adequately support it. This study provides insight into the various barriers and enablers faced by NHPs and pharmacists when deprescribing in nursing homes. Specific for this population, deprescribing barriers focus on communication (with residents and their relatives, and also with medical specialists) and resources, while knowledge and expertise are mentioned as enablers.
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Introduction Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals’ management of smoking in Indigenous pregnant women—the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance. The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers. Methods and analysis This protocol describes the design of a step-wedge cluster randomised pilot study. Six Aboriginal Medical Services (AMSs) are randomised into three clusters. Clusters receive the intervention staggered by 1 month. Health professionals report on their knowledge and skills pretraining and post-training and at the end of the study. Pregnant women are recruited and followed up for 3 months. The primary outcome is the recruitment rate of pregnant women. Secondary outcomes include feasibility of recruitment and follow-up of participating women, and webinar training of health professionals, measured using a designated log; and measures of effectiveness outcomes, including quit rates and NRT prescription rates. Ethics and dissemination In accordance with the Aboriginal Health and Medical Research Council guidelines, this study has been developed in collaboration with a Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP). The SCAAP provides cultural consultation, advice and direction to ensure that implementation is acceptable and respectful to the Aboriginal communities involved. Results will be disseminated to AMSs, Aboriginal communities and national Aboriginal bodies. Registration details This protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN12616001603404).
Article
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Aim To gather Aboriginal women’s stories of smoking and becoming pregnant to identify the barriers in accepting smoking cessation support during pregnancy. Methods Qualitative data were collected through use of yarning methodology between August 2015 and January 2016 by an Aboriginal Researcher with experience in social and community services. A short on-line survey was used to collect quantitative data. Interviews only recorded the therapeutic yarning process, which ranged from 9 to 45 min duration, averaging 30 min. Audio-recorded interviews were transcribed and independently coded. A general inductive analysis was used to determine emergent themes. Results Twenty Aboriginal women between 17–38 years of age, who were pregnant or recently given birth, living in the Hunter New England (HNE) area took part. Eleven women were still smoking; nine had quit. Most were highly aware of the implications of smoking for their babies. Major themes identified for accepting support were: ambivalence towards a need for support, health professional advice, reduction in smoking, and attitudes to Nicotine Replacement Therapy (NRT). Women reported being advised to cut down, rather than to quit; reducing consumption may be a barrier to accepting NRT. Women recommended enhanced clinical support and Aboriginal community engagement in cessation care. Discussion/conclusions Aboriginal women in the HNE area reported quitting or reducing their cigarette intake during pregnancy. Health Professionals working with Aboriginal women during pregnancy should give consistent messages to quit smoking completely, and offer increased, ongoing and extensive smoking cessation support to Aboriginal mothers. Clinical practices could partner with Aboriginal communities to support the delivery of smoking cessation services.
Article
Full-text available
Abstract Introduction: Similar to other high-income countries, smoking rates in pregnancy can be high in specific vulnerable groups in Australia. Several clinical guidelines exist, including the 5A’s (Ask, Advice, Assess, Assist, and Arrange), ABCD (Ask, Brief advice, Cessation, and Discuss), and AAR (Ask, Advice, and Refer). There is lack of data on provision of smoking cessation care (SCC) of Australian General Practitioners (GPs) and Obstetricians. Methods: A cross-sectional survey explored the provision of SCC, barriers and enablers using the Theoretical Domains Framework, and the associations between them. Two samples were invited: (1) GPs and Obstetricians from a college database (n = 5571); (2) GPs from a special interest group for Indigenous health (n = 500). Dimension reduction for the Theoretical Domains Framework was achieved with factor analysis. Logistic regression was carried out for performing all the 5A’s and the AAR. Results: Performing all of the 5A’s, ABCD, and AAR “often and always” was reported by 19.9%, 15.6%, and 49.2% respectively. “Internal influences” (such as confidence in counselling) were associated with higher performance of the 5A’s (Adjusted OR 2.69 (95% CI 1.5, 4.8), p < .001), whereas “External influences” (such as workplace routine) were associated with higher performance of AAR (Adjusted OR 1.7 (95% CI 1, 2.8), p = .035). Conclusions: Performance in providing SCC to pregnant women is low among Australian GPs and Obstetricians. Training clinicians should focus on improving internal influences such as confidence and optimism. The AAR may be easier to implement, and interventions at the service level should focus on ensuring easy, effective, and acceptable referral mechanisms are in place. Implications: Improving provision of the 5A’s approach should focus on the individual level, including better training for GPs and Obstetricians, designed to improve specific “internal” barriers such as confidence in counselling and optimism. The AAR may be easier to implement in view of the higher overall performance of this approach. Interventions on a more systemic level need to ensure easy, effective, and acceptable referral mechanisms are in place. More research is needed specifically on the acceptability of the Quitline for pregnant women, both Indigenous and non-Indigenous.
Article
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Tobacco smoking leads to one in five deaths of Aboriginal Australians and accounts for 17% of the reversible health gap. One in two Aboriginal women are reported to smoke during pregnancy, with no effective strategies currently available for health practitioners to utilise for supporting Aboriginal women. Aboriginal community participation in primary health research is crucial to implementing ethical research, with a clear benefit to the people and communities involved. However, currently there is little evidence on how Aboriginal programs and interventions are being developed in partnership with Aboriginal people and communities. ‘Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy’ aims to address the prevalence of smoking during pregnancy by enhancing health providers’ training in offering evidence-based smoking cessation care to Aboriginal mothers during pregnancy. This paper outlines the participatory research approach adopted for the developmental phase of the ‘ICAN QUIT in Pregnancy’ project developed in partnership with two Aboriginal Community-Controlled Health Services in NSW, and negotiation processes undertaken to implement a pilot intervention across NSW, SA and Qld.
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Background: Self-management interventions are considered effective in patients with chronic disease, but trials have shown inconsistent results, and it is unknown which patients benefit most. Adequate self-management requires behaviour change in both patients and health care providers. Therefore, the Activate intervention was developed with a focus on behaviour change in both patients and nurses. The intervention aims for change in a single self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease. The aim of this study is to evaluate the effectiveness of the Activate intervention. Methods/design: A two-arm cluster randomised controlled trial will be conducted to compare the Activate intervention with care as usual at 31 general practices in the Netherlands. Approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention is developed using the Behaviour Change Wheel and consists of 4 nurse-led consultations in a 3-month period, integrating 17 behaviour change techniques. The Behaviour Change Wheel was also applied to analyse what behaviour change is needed in nurses to deliver the intervention adequately. This resulted in 1-day training and coaching sessions (including 21 behaviour change techniques). The primary outcome is physical activity, measured as the number of minutes of moderate to vigorous physical activity using an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline number of minutes of physical activity. Data will be collected at baseline and at 3 months and 6 months of follow-up. A process evaluation will be conducted to evaluate the training of nurses, treatment fidelity, and to identify barriers to and facilitators of implementation as well as to assess participants' satisfaction. Discussion: To increase physical activity in patients and to support nurses in delivering the intervention, behaviour change techniques are applied to change behaviours of the patients and nurses. Evaluation of the effectiveness of the intervention, exploration of which patients benefit most, and evaluation of our theory-based training for primary care nurses will enhance understanding of what works and for whom, which is essential for further implementation of self-management in clinical practice. Trial registration: ClinicalTrials.gov identifier: NCT02725203 . Registered on 25 March 2016.
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Introduction: Tobacco use during pregnancy is substantially higher among Aboriginal women compared to non-Aboriginal women in Australia. However, no studies have investigated the amount or type of smoking cessation care that staff from Aboriginal antenatal and postnatal services provide to clients who smoke or staff confidence to do so. This study examined Aboriginal antenatal and postnatal staff confidence, perceived role and delivery of smoking cessation care to Aboriginal women and characteristics associated with provision of such care. Methods: Staff from 11 Aboriginal Maternal and Infant Health Services and eight Aboriginal Child and Family Health services in the Hunter New England Local Health District in Australia completed a cross-sectional self-reported survey (n = 67, response rate = 97.1%). Results: Most staff reported they assessed clients' smoking status most or all of the time (92.2%). However, only a minority reported they offered a quitline referral (42.2%), provided follow-up support (28.6%) or provided nicotine replacement therapy (4.7%) to most or all clients who smoked. Few staff felt confident in motivating clients to quit smoking (19.7%) and advising clients about using nicotine replacement therapy (15.6%). Staff confident with talking to clients about how smoking affected their health had significantly higher odds of offering a quitline referral [OR = 4.9 (1.7-14.5)] and quitting assistance [OR = 3.9 (1.3-11.6)] to clients who smoke. Conclusions: Antenatal and postnatal staff delivery of smoking cessation care to pregnant Aboriginal women or mothers with young Aboriginal children could be improved. Programs that support Aboriginal antenatal and postnatal providers to deliver smoking cessation care to clients are needed. Implications: Aboriginal antenatal and postnatal service staff have multiple opportunities to assist Aboriginal women to quit smoking during pregnancy and postpartum. However, staff confidence and practices of offering various forms of smoking cessation support to pregnant Aboriginal women is unexplored. This is the first study to examine the amount and type of smoking cessation support Aboriginal antenatal and postnatal service staff provide to Aboriginal women, staff confidence and their perceived role in delivering smoking cessation care. This information is valuable for developing strategies that assist antenatal and postnatal staff to improve their delivery of smoking cessation care to Aboriginal women.
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Objective One in two Indigenous Australian pregnant women smoke, yet little is known about their trajectory of smoking. This study aimed to explore Aboriginal women's narratives from starting smoking through to pregnancy. Methods A female Aboriginal Researcher conducted individual face-to-face interviews with 20 Aboriginal women from New South Wales, Australia. Recruitment, through Aboriginal services and community networks, continued until saturation was reached. Audio-recorded transcripts were independently open coded by two researchers, inductively analysed and reported using a three-dimensional structure of looking backwards, forwards, inwards, outwards and a sense of place, to elucidate the chronology of events, life stages, characters, environments, and turning points of the stories. Results A chronology emerged from smoking initiation in childhood, coming of age, becoming pregnant, through to attempts at quitting, and relapse post-partum. Several new themes emerged: the role mothers play in women's smoking and quitting; the contribution of nausea to spontaneous quitting; depression as a barrier to quitting; and the hopes of women for their own and their children's future. The epiphany of pregnancy was a key turning point for many – including the interplay of successive pregnancies; and the intensity of expressed regret. Conclusions Aboriginal women report multiple influences in the progression of early smoking to pregnancy and beyond. Potential opportunities to intervene include: a) childhood, coming of age, pregnancy, post-natal, in-between births; b) key influencers; c) environments, and d) targeting concurrent substance use. Morning sickness appears to be a natural deterrent to continued smoking. Depression, and its relationship to smoking and quitting in Australian Indigenous pregnant women, requires further research.
Article
Introduction: Pregnant women in socioeconomically disadvantaged circumstances, such as Indigenous women, have a high prevalence of smoking. Tobacco smoking is the most significant reversible risk factor for the health of Indigenous pregnant women and their babies. Methods: As researchers working in this specialized area, we conducted a narrative review of the literature on smoking among Indigenous pregnant women in the United States, Canada, New Zealand, and Australia. We summarize prevalence and factors influencing tobacco use, interventions, and evidence gaps for tobacco control and smoking cessation. Recommendations are made for future interventions, policy changes, and much-needed research. Results: Common themes emerging across the four countries reveal opportunities for cross-cultural collaborative studies and trials. These include the social-normative use of tobacco as barriers to quitting in pregnancy and the need for evaluations of interventions at the family and community level. Socioeconomic disparities underscore the importance of enhancing the implementation and reach of strategies to prevent and reduce prenatal tobacco smoking among Indigenous women. Elders and community health care providers as role models for nontobacco use could be explored. Qualitative work is needed to understand the barriers and opportunities, such as cultural strengths supporting quitting tobacco to develop more effective approaches. Conclusions: Although a high-priority group, there remains a dearth of research on Indigenous women's smoking in pregnancy. Studies have assessed knowledge and attitudes to smoking in pregnancy, and small feasibility studies and a few empirical trials have been conducted. Recommendations for promising culturally appropriate cessation interventions have been made. Larger trials are warranted. Implications: Strategies to support quitting among pregnant Indigenous women need to be multifactorial and take account of the social determinants of smoking including historical antecedents, community norms, cultural strengths, and recognition of individual and community needs. Cross-country research collaborations have the potential to leverage funding, share expertise, and strengthen approaches to tackle an important and poorly attended health disparity that has a profound impact on the entire life course for Indigenous peoples.
Article
Background: Tobacco smoking remains one of the few preventable factors associated with complications in pregnancy, and has serious long-term implications for women and babies. Smoking in pregnancy is decreasing in high-income countries, but is strongly associated with poverty and is increasing in low- to middle-income countries. Objectives: To assess the effects of smoking cessation interventions during pregnancy on smoking behaviour and perinatal health outcomes. Search methods: In this sixth update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register (13 November 2015), checked reference lists of retrieved studies and contacted trial authors. Selection criteria: Randomised controlled trials, cluster-randomised trials, and quasi-randomised controlled trials of psychosocial smoking cessation interventions during pregnancy. Data collection and analysis: Two review authors independently assessed trials for inclusion and trial quality, and extracted data. Direct comparisons were conducted in RevMan, with meta-regression conducted in STATA 14. Main results: The overall quality of evidence was moderate to high, with reductions in confidence due to imprecision and heterogeneity for some outcomes. One hundred and two trials with 120 intervention arms (studies) were included, with 88 trials (involving over 28,000 women) providing data on smoking abstinence in late pregnancy. Interventions were categorised as counselling, health education, feedback, incentives, social support, exercise and dissemination.In separate comparisons, there is high-quality evidence that counselling increased smoking cessation in late pregnancy compared with usual care (30 studies; average risk ratio (RR) 1.44, 95% confidence interval (CI) 1.19 to 1.73) and less intensive interventions (18 studies; average RR 1.25, 95% CI 1.07 to 1.47). There was uncertainty whether counselling increased the chance of smoking cessation when provided as one component of a broader maternal health intervention or comparing one type of counselling with another. In studies comparing counselling and usual care (largest comparison), it was unclear whether interventions prevented smoking relapse among women who had stopped smoking spontaneously in early pregnancy. However, a clear effect was seen in smoking abstinence at zero to five months postpartum (11 studies; average RR 1.59, 95% CI 1.26 to 2.01) and 12 to 17 months (two studies, average RR 2.20, 95% CI 1.23 to 3.96), with a borderline effect at six to 11 months (six studies; average RR 1.33, 95% CI 1.00 to 1.77). In other comparisons, the effect was unclear for most secondary outcomes, but sample sizes were small.Evidence suggests a borderline effect of health education compared with usual care (five studies; average RR 1.59, 95% CI 0.99 to 2.55), but the quality was downgraded to moderate as the effect was unclear when compared with less intensive interventions (four studies; average RR 1.20, 95% CI 0.85 to 1.70), alternative interventions (one study; RR 1.88, 95% CI 0.19 to 18.60), or when smoking cessation health education was provided as one component of a broader maternal health intervention.There was evidence feedback increased smoking cessation when compared with usual care and provided in conjunction with other strategies, such as counselling (average RR 4.39, 95% CI 1.89 to 10.21), but the confidence in the quality of evidence was downgraded to moderate as this was based on only two studies and the effect was uncertain when feedback was compared to less intensive interventions (three studies; average RR 1.29, 95% CI 0.75 to 2.20).High-quality evidence suggests incentive-based interventions are effective when compared with an alternative (non-contingent incentive) intervention (four studies; RR 2.36, 95% CI 1.36 to 4.09). However pooled effects were not calculable for comparisons with usual care or less intensive interventions (substantial heterogeneity, I(2) = 93%).High-quality evidence suggests the effect is unclear in social support interventions provided by peers (six studies; average RR 1.42, 95% CI 0.98 to 2.07), in a single trial of support provided by partners, or when social support for smoking cessation was provided as part of a broader intervention to improve maternal health.The effect was unclear in single interventions of exercise compared to usual care (RR 1.20, 95% CI 0.72 to 2.01) and dissemination of counselling (RR 1.63, 95% CI 0.62 to 4.32).Importantly, high-quality evidence from pooled results demonstrated that women who received psychosocial interventions had a 17% reduction in infants born with low birthweight, a significantly higher mean birthweight (mean difference (MD) 55.60 g, 95% CI 29.82 to 81.38 g higher) and a 22% reduction in neonatal intensive care admissions. However the difference in preterm births and stillbirths was unclear. There did not appear to be adverse psychological effects from the interventions.The intensity of support women received in both the intervention and comparison groups has increased over time, with higher-intensity interventions more likely to have higher-intensity comparisons, potentially explaining why no clear differences were seen with increasing intervention intensity in meta-regression analyses. Among meta-regression analyses: studies classified as having 'unclear' implementation and unequal baseline characteristics were less effective than other studies. There was no clear difference between trials implemented by researchers (efficacy studies), and those implemented by routine pregnancy staff (effectiveness studies), however there was uncertainty in the effectiveness of counselling in four dissemination trials where the focus on the intervention was at an organisational level. The pooled effects were similar in interventions provided for women classified as having predominantly low socio-economic status, compared to other women. The effect was significant in interventions among women from ethnic minority groups; however not among indigenous women. There were similar effect sizes in trials with biochemically validated smoking abstinence and those with self-reported abstinence. It was unclear whether incorporating use of self-help manuals or telephone support increased the effectiveness of interventions. Authors' conclusions: Psychosocial interventions to support women to stop smoking in pregnancy can increase the proportion of women who stop smoking in late pregnancy and the proportion of infants born low birthweight. Counselling, feedback and incentives appear to be effective, however the characteristics and context of the interventions should be carefully considered. The effect of health education and social support is less clear. New trials have been published during the preparation of this review and will be included in the next update.
Article
Background: Indigenous pregnant women have a high smoking prevalence (47%). Health providers (HPs) report lack of adequate resources. Messages need to be tailored to ensure saliency, cultural-sensitivity and account for Indigenous population diversity. The ICAN QUIT in Pregnancy intervention aims to improve HP’s management of smoking in Indigenous pregnant smokers. A resource package was developed collaboratively with two Aboriginal Community Controlled Health Services (ACCHS). Aims: To assess the scientific accuracy, cultural acceptability, perceived useability and readability of the resources. Methods: A multicentered community-based participatory process, with four ACCHS from NSW, SA and QLD. A four-step process included: (i) scientific review by a multidisciplinary expert panel (10 members); (ii) scoring for “Suitability of Materials” by two Aboriginal Health Workers. Mean overall score and inter-rater agreement will use Cohen’s kappa coefficient; (iii) focus groups – two groups (HPs and community members) in each ACCHS will explore views about the resources and opportunities for improvement; and (iv) readability scores: an average level of grade 5 for patient’s resources and grade 10 for HP’s resources. Results: Major themes from the scientific panel and suitability assessment of material (SAM) evaluation included “High attraction”, “Simplifying the resources” and “Additional information (depression/e-cig/stress).” Average readability score was grade 6 (patient resources, range 0.2–12.5) and grade 9.4 (HP’s resources, range 4.7–31.4). Results from focus groups discussions will be presented in reference to predefined themes. Resources will be adjusted accordingly. Conclusions: This process will ensure that materials used for ICAN QUIT in Pregnancy are culturally sensitive and evidence-based. This formative evaluation technique has never been done in Australia. If effective, it could be adapted for other Indigenous interventions and culturally diverse programs. Translational research aspect: This is a T2–T3 research using knowledge from previous research with Indigenous women and HPs, and evidence-based approaches to managing smoking in pregnancy, to develop and implement an intervention within ACCHS.