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Trial registered on ANZCTR


Registration number
ACTRN12618000972224
Ethics application status
Approved
Date submitted
20/03/2018
Date registered
8/06/2018
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
SISTAQUIT (Supporting Indigenous Smokers to Assist Quitting)

The SISTAQUIT trial compares usual care to health provider training in culturally-appropriate smoking cessation care for pregnant Aboriginal and/or Torres Strait Islander women.
Scientific title
SISTAQUIT (Supporting Indigenous Smokers to Assist Quitting)
A Cluster Randomised Controlled Trial to Improve Strategies for the Management of Smoking Cessation in Pregnant Aboriginal and/or Torres Strait Islander Women
Secondary ID [1] 294308 0
None
Universal Trial Number (UTN)
U1111-1210-3753
Trial acronym
SISTAQUIT
Linked study record
ACTRN 12616001603404 (ICAN QUIT in Pregnancy pilot study)

Health condition
Health condition(s) or problem(s) studied:
Management of smoking during pregnancy for Aboriginal and Torres Strait Islander women 307018 0
Tobacco smoking during pregnancy 307019 0
Respiratory health of babies from birth to 6 months of age 307020 0
Condition category
Condition code
Public Health 306119 306119 0 0
Health promotion/education
Reproductive Health and Childbirth 306120 306120 0 0
Antenatal care
Mental Health 306121 306121 0 0
Addiction
Public Health 306122 306122 0 0
Health service research
Respiratory 306125 306125 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SISTAQUIT is a cluster randomised controlled trial (RCT) at 30 Aboriginal Community Controlled Health Services (ACCHSs), Aboriginal Medical Services (AMS) and General Practitioner (GP) practices across Australia.

Each health service/GP practice will be randomly assigned to continue usual care (15 Control sites) or receive the SISTAQUIT health provider training in culturally appropriate smoking cessation care + resources at the start of the study (15 Intervention sites).

The 15 Control sites will receive the SISTAQUIT training + resources at the end of the study (Intervention-later group)..

The SISTAQUIT Intervention comprises::
- culturally appropriate training in smoking cessation care for health providers (2 hours)
Health providers include GPs, midwives, nurses, Tobacco & Aboriginal Health Workers
Ideally, all health providers at each service/GP practice (especially those who provide
care for pregnant women) will undertake the training
- targeted educational resources: participant booklet & flip chart, health provider manual
- oral nicotine replacement therapy (oral NRT)
- participant smoking cessation information video loop

All sites (Intervention + Control) receive:
- trial implementation training & support throughout the study
- reimbursement for trial activities

The Intervention training comprises two approximately 1-hour sessions presented onsite by an Aboriginal member of the SISTAQUIT team. The sessions centre on two pre-recorded training videos of culturally-appropriate smoking cessation care, presented by both a GP specialiasing in smoking cessation care and an Aboriginal Health Educator.

Participants at study sites will be followed for the smoking cessation care they receive via surveys at trial follow up time points. Health providers may optionally participate in pre-study, post-training and end of study surveys to assess their skills and confidence in providing smoking cessation care for pregnant Indigenous women.
Intervention code [1] 300616 0
Behaviour
Intervention code [2] 300617 0
Prevention
Comparator / control treatment
Control centres (15) will continue usual care for their pregnant participants, but will receive the SISTAQUIT Intervention + resources at the end of the study.

The control group is therefore a 'delayed' Intervention group.

Control sites have the option of undertaking the training + resources after their last participant (e.g. the 15th woman who agrees to participate at that particular Control site) gives birth.

Control sites will receive training in trial methods at the start of the study and implementation support throughout the study, as well as reimbursement for trial activities.
Control group
Active

Outcomes
Primary outcome [1] 305146 0
Smoking cessation status self report
(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [1] 305146 0
4 weeks after recruitment to the trial
Primary outcome [2] 305325 0
Carbon monoxide (CO) validated smoking cessation status
Timepoint [2] 305325 0
4 weeks after recruitment to the trial
Secondary outcome [1] 344309 0
Smoking cessation status self report
(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [1] 344309 0
- 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)
Secondary outcome [2] 344310 0
Carbon monoxide (CO) validated smoking cessation status
(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [2] 344310 0
- 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)
Secondary outcome [3] 344311 0
Reduction of episodes of respiratory illness among babies followed for 6 months
(babies of participants at Intervention centres vs babies at Control centres)

Pregnant participants can optionally consent for their babies to be followed from birth to 6 months

Babies' respiratory illness outcomes will be collected via a custom survey designed for the trial
Timepoint [3] 344311 0
- monthly from birth through 6 months of age
- at 6 months
Secondary outcome [4] 344313 0
Perinatal outcomes of babies
(babies of participants at Intervention centres vs babies at Control centres)

Pregnant participants can optionally consent for their babies to be followed from birth to 6 months

Data to be collected via birth discharge summary (deidentified & relabelled with study ID) and related health records
Timepoint [4] 344313 0
- at birth
- at 6 months
Secondary outcome [5] 344314 0
Health outcomes of participating mothers during pregnancy and at birth
(such as use of medical services, pre-eclampsia and associated symptoms (e.g. hypertension, proteinuria, cerebral edema)

Data to be collected via birth discharge summary, and possibly via other health record extracts

(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [5] 344314 0
Throughout pregnancy and at birth
Secondary outcome [6] 344316 0
The economic evaluation will utilise the primary outcome measure and the outcome measure of respiratory illness among babies for the effectiveness component of the CEA.

Resource utilisation (the costs) for the economic evaluation will include the marginal cost of the intervention compared to usual care. Health care utilisation for both mother and baby for both trial groups will be assessed from trial participation through to 6 months following birth of the child. The health care resource utilisation of mothers will be derived from AMS/GP data, hospital records and the health diary. The health care utilisation of participating babies born to participating mothers in both groups will also be assessed, where available, using: the audit of babies’ records from AMS/GP practices, hospital records, birth records/ discharge summary, the babies’ personal health record and the mother’s health diary.
Timepoint [6] 344316 0
Some of the information used in the economic analysis will be provided by surveys undertaken by trial participants at baseline (recruitment), 4 & 12 weeks on-study, 36 weeks gestation and 4 weeks post-partum. The remainder will be collected throughout the study by participating sites from the sources described above.
Secondary outcome [7] 344320 0
Measurement of quit attempts as recorded on the participant follow up surveys (designed specifically for this study)
(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [7] 344320 0
- 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)
Secondary outcome [8] 344321 0
The baseline and follow up characteristics of the participants (e.g. demographic, smoking characteristics, attitudes, and depression scores, and self-reported empowerment & wellbeing via the GEM (Growth and Empowerment) survey) among mothers in the intervention vs the control group will be compared to determine the predictors of smoking behaviour changes
Timepoint [8] 344321 0
- at recruitment to the study (baseline) - 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth - 6 months post partum (after giving birth)
Secondary outcome [9] 344322 0
Proportion of Health Providers (HPs) offering NRT (Nicotine Replacement Therapy) to trial participants as part of their smoking cessation care, as recorded on the trial oral NRT record and oral NRT vouchers (provided to each participating centre), as well as prescriptions for (patch) NRT.

(HPs at Intervention centres vs HPs at usual care (Control) centres)

NB: Oral NRT is currently not available on the PBS. If oral NRT becomes listed on the PBS, then scripts (for both oral NRT and NRT patches) may be the sole measure.
Timepoint [9] 344322 0
- at recruitment to the study (baseline) - 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth - 6 months post partum (after giving birth)
Secondary outcome [10] 344323 0
Proportion of HPs offering smoking cessation care to trial participants, as recorded on a checklist which is part of the participant baseline and follow up visit surveys.

(HPs at Intervention centres vs HPs at usual care (Control) centres)
Timepoint [10] 344323 0
- at recruitment to the study (baseline)
- 4 weeks on study (4 weeks after recruitment)
- 12 weeks on study (12 weeks after recruitment)
- 36 weeks gestation
- 4 weeks post partum (after giving birth)
Secondary outcome [11] 344324 0
Proportion of HPs offering smoking cessation care to all pregnant women attending participating centres up to 12 months prior to the start of the study at that centre, as extracted from the electronic records of participating sites.
Timepoint [11] 344324 0
- Up to 12 months prior to activation of the trial at each participating centre
Secondary outcome [12] 344325 0
Proportion of HPs offering smoking cessation care to trial participants, as recorded on extracts from participants' health records (de-identified & relabelled with participant ID)

(HPs at Intervention centres vs HPs at usual care (Control) centres)
Timepoint [12] 344325 0
- from recruitment through the 4-week post-partum visit for each participant
Secondary outcome [13] 344326 0
HP self- reported knowledge, attitudes and skills in managing smoking cessation for Aboriginal and Torres Strait Islander pregnant women.

(HPs at Intervention centres vs HPs at usual care (Control) centres)
Timepoint [13] 344326 0

at the start of the study at each participating centre, - 2 months after the start of the study at each centre - 12 months after the start of the study at each centre
Secondary outcome [14] 344327 0
Comparison of the Behaviour Change Techniques (BCT) and decision-making processes regarding smoking cessation care at Intervention vs Control centres, as transcribed from audio-recordings of HP and participant consultations (with consent from both the HP and participant)
Timepoint [14] 344327 0
- at any time from recruitment through the 6 month post-partum visit for each participant
Secondary outcome [15] 344841 0
Participant self-reported use and adherence to NRT, as recorded on participant surveys
(participants at Intervention centres vs participants at usual care (Control) centres)
Timepoint [15] 344841 0
- at recruitment to the study (baseline) - 4 weeks on study (4 weeks after recruitment) - 12 weeks on study (12 weeks after recruitment) - 36 weeks gestation - 4 weeks post partum (after giving birth) - 6 months post partum (after giving birth)

Eligibility
Key inclusion criteria
Participants:
• Pregnant
• Up to and including 32 weeks gestation
• Aboriginal and/or Torres Strait Islander (or expectant mothers of an Aboriginal and/or Torres Strait Islander baby)
• Smoke tobacco (any amount)
• Able to provide informed consent
• Attending antenatal care at one of the 30 AMS/GP practices participating in SISTAQUIT

Centres (Aboriginal Community Controlled Health Services (ACCHS)/Aboriginal Medical Services (AMS), GP practices):
1. A health service confirming pregnancy or providing antenatal or routine care for pregnant
mothers of Aboriginal or Torres Strait Islander babies.
2. Employ at least one GP who can participate in the training.
Participation of centres without a GP onsite will be reviewed on a case by case basis, e.g.
to determine if another health professional is available to undertake a prescribing role (for
NRT), or if a memorandum of understanding can be made with a local GP to undertake
this role. These alternative responsible parties will need to undertake the full webinar
training and study briefing in trial methods to ensure compatibility with the SISTAQUIT
Intervention and trial procedures.
3. Have contact with at least 20 pregnant mothers of Aboriginal babies who smoke/year
(ideally at one location (i.e. ‘clinic’) within each Service, and at most two clinics within any
ACCHS/AMS/GP practice)
4. Are able to recruit and follow patients as required
5. At least 30 km radius from other sites recruited to the study
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants:
• Women who are not able to give informed consent.
Please note that women may still participate in the study even if they do not wish their
baby’s outcomes to be followed. (This is not an exclusion criteria.)
• Non-smoker

Centres (Aboriginal Community Controlled Health Services, AMS, GP practices):
Centres not meeting the above Centre Inclusion Criteria may still be eligible to participate if certain minimum requirements are met (e.g. as described above, the centre has access to a local GP who can undertake the training and prescribe NRT)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The AMS/GP practice manager/s, research facilitator/s, and health providers will not be blind to their allocation group. Women participating in the study will not be informed of the service allocation and providers will be asked not to disclose this information. However if this information is disclosed it does not jeopardise the trial as the health providers are not blind to the allocation. Statistical analysis will be done with a statistician blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sites will be randomised to receive either the webinar training or the control group using standard practice. Stratified by the Australian Standard Geographical Classification – Remoteness Area, block randomisation will be employed using independent statisticians and a computer generated random number sequence method. Services in intervention and control groups will be isolated from one another by at least 30kms to avoid cross-contamination between groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participating sites are the unit of randomisation (Cluster randomised controlled trial)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size & Power Calculation
Based on standard Randomised Controlled Trial (RCT) of provider training.
Primary outcome 4-weeks: Assuming an Intra Class Correlation (ICC) of 0.01 (median for primary care research), it is calculated that a sample size of approximately 30 Aboriginal Medical Services (AMS) and/or General Practioner (GP) practices (15 in each arm) with an average of 13 women per practice will give the study 80% power to detect an increase in the primary outcome from 3% in the control group to 11% in the intervention group at the primary endpoint of 12-weeks with a 5% type 1 error rate. Allowing for a 15% loss to follow-up, at 12- weeks, we would need to recruit 450 women at baseline (225 per arm). A non-significant assisted quit rate of 11% was achieved in previous study (control 5%). Because of study arm contamination, and in reference to the literature, a baseline rate of 3% is more likely, with an absolute difference of 7% being achievable in our trial at 4-weeks. Other time-points: A sample of this size will enable detectable increases of 8% at 12-weeks, and 75% power to detect sustained 8 % increase at 36-weeks gestation and 4-weeks post-partum. Feasibility of patient sample: With 30 AMSs/GP practices, each seeing at least 20 eligible pregnant Aboriginal smokers per year, there will be a pool of 600 eligible participants available. Assuming approximately 70% of these will consent, we will have access to 450 participants in the first year.

DATA ANALYSIS
Primary Outcome
The primary analysis will compare smoking cessation rates of pregnant smokers at 4-weeks (also 12-weeks, 36-weeks gestation and 4-weeks post-partum) between treatment groups and will follow the intent-to-treat principle with multiple imputation the primary method of dealing with missing data (assuming missing at random). Missing data will be filled-in using logic where possible (e.g. if smoking at previous time-point then not possible to have continued abstinence at the current time point) and otherwise the method of chained equations will be used, where the imputation model will include a range of covariates believed to be associated with either the missing outcome or the outcome itself (e.g. previous quit attempts, consultations about quitting and self-efficacy). Intervention efficacy will be assessed by fitting a mixed effects logistic regression model to each of the imputed datasets, where the outcome variable will be carbon monoxide (CO) validated continuous abstinence or not, and 7-day abstinence or not (for sensitivity analysis). Separate models will be fit at each time point. The models will include a fixed effect for treatment group (Intervention vs Control), and stratification variable (location) and a random treatment centre effect to account for clustering of participants within practices. Variables prognostic of the outcome variable (previous quit attempts, consultations about quitting, and self-efficacy) will be included in the model as covariates to improve power. Regression coefficients and standard errors from all imputed data sets will be pooled. Sensitivity analysis will be performed by fitting models that make different assumptions about the missing data mechanism (e.g. Missing Not at Random). A secondary longitudinal analysis will utilise data from each follow-up, including a random subject level intercept to model serial correlations.
Patient characteristics (e.g. dependence levels, smoking status, home smoking, depression scores from Patient Health Questionnaire 9 (PHQ9)) will be compared between time periods using chi-square tests for categorical variables and t-tests for continuous variables; factors found to be different between time periods will be included in the regression as covariates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2018
Actual
5/10/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
450
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 298956 0
Government body
Name [1] 298956 0
National Health and Medical Research Council (NHMRC)
Country [1] 298956 0
Australia
Funding source category [2] 299704 0
Charities/Societies/Foundations
Name [2] 299704 0
Global Alliance for Chronic Diseases (GACD)
Country [2] 299704 0
United Kingdom
Funding source category [3] 299705 0
Government body
Name [3] 299705 0
Cancer Institute New South Wales (CINSW)
Country [3] 299705 0
Australia
Funding source category [4] 299706 0
Government body
Name [4] 299706 0
Cancer Australia
Country [4] 299706 0
Australia
Funding source category [5] 299707 0
Charities/Societies/Foundations
Name [5] 299707 0
Cure Cancer Australia Foundation
Country [5] 299707 0
Australia
Funding source category [6] 299708 0
University
Name [6] 299708 0
University of Newcastle
Country [6] 299708 0
Australia
Funding source category [7] 299709 0
University
Name [7] 299709 0
Centre for Brain and Mental Health Research (CBMHR)
Country [7] 299709 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 298236 0
None
Name [1] 298236 0
Address [1] 298236 0
Country [1] 298236 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299891 0
The University of Newcastle Human Research Ethics Committee (UON HREC)
Ethics committee address [1] 299891 0
Ethics committee country [1] 299891 0
Australia
Date submitted for ethics approval [1] 299891 0
07/02/2018
Approval date [1] 299891 0
Ethics approval number [1] 299891 0
Ethics committee name [2] 299940 0
The Aboriginal Health and Medical Research Council Human Research Ethics Committee (AHMRC HREC)
Ethics committee address [2] 299940 0
Ethics committee country [2] 299940 0
Australia
Date submitted for ethics approval [2] 299940 0
06/02/2018
Approval date [2] 299940 0
07/03/2018
Ethics approval number [2] 299940 0
1140/15
Ethics committee name [3] 299941 0
Western Australian Aboriginal Health Ethics Committee (WAAHEC)
Ethics committee address [3] 299941 0
Ethics committee country [3] 299941 0
Australia
Date submitted for ethics approval [3] 299941 0
15/09/2017
Approval date [3] 299941 0
Ethics approval number [3] 299941 0
Ethics committee name [4] 299942 0
The Human Research Ethics Committee of the Northern Territory Dept of Health and Menzies School of Health Research (Menzies HREC)
Ethics committee address [4] 299942 0
Ethics committee country [4] 299942 0
Australia
Date submitted for ethics approval [4] 299942 0
07/11/2017
Approval date [4] 299942 0
Ethics approval number [4] 299942 0
Ethics committee name [5] 299943 0
Darling Downs Hospital and Health Service Human Research Ethics Committee (Darling Downs HREC)
Ethics committee address [5] 299943 0
Ethics committee country [5] 299943 0
Australia
Date submitted for ethics approval [5] 299943 0
22/01/2018
Approval date [5] 299943 0
Ethics approval number [5] 299943 0
Ethics committee name [6] 299944 0
Far North Queensland Human Research Ethics Committee (FNQ HREC)
Ethics committee address [6] 299944 0
Ethics committee country [6] 299944 0
Australia
Date submitted for ethics approval [6] 299944 0
06/03/2018
Approval date [6] 299944 0
Ethics approval number [6] 299944 0
Ethics committee name [7] 303534 0
ABORIGINAL HEALTH RESEARCH ETHICS COMMITTEE (AHREC)
Ethics committee address [7] 303534 0
Ethics committee country [7] 303534 0
Australia
Date submitted for ethics approval [7] 303534 0
22/11/2018
Approval date [7] 303534 0
03/12/2018
Ethics approval number [7] 303534 0
AHREC Protocol 04-16-652

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81886 0
A/Prof Gillian Gould
Address 81886 0
Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 81886 0
Australia
Phone 81886 0
+61 (0)403615563
Fax 81886 0
61 (0)2 4033 5692
Email 81886 0
[email protected]
Contact person for public queries
Name 81887 0
Gillian Gould
Address 81887 0
Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 81887 0
Australia
Phone 81887 0
+61 (0)403615563
Fax 81887 0
61 (0)2 4033 5692
Email 81887 0
[email protected]
Contact person for scientific queries
Name 81888 0
Gillian Gould
Address 81888 0
Level 4, Hunter Medical Research Institute
School of Medicine and Public Health
The University of Newcastle
PO Box 833
Newcastle NSW 2300
Country 81888 0
Australia
Phone 81888 0
+61 (0)403615563
Fax 81888 0
61 (0)2 4033 5692
Email 81888 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
SISTAQUIT acknowledges the principles of and the right to Data Sovereignty, for Aboriginal and Torres Strait Islander peoples---
(From the Maiam nayri Wingara (www.maiamnayriwingara.org) Briefing paper, 2018):
"Indigenous Data Sovereignty is the right of Indigenous peoples to determine the means of collection, access, analysis, interpretation, management, dissemination and reuse of data pertaining to the Indigenous peoples from whom it has been derived, or to whom it relates. Indigenous data sovereignty centres on Indigenous collective rights to data about our peoples, territories, lifeways and natural resources (Kukutai & Taylor 2016; Snipp 2016)."
Given the very sensitive nature of the data being collected, the trial protocol states that all data collected will be published only in a non-identifying (aggregate) form, and that sites and/or health providers will only be identified in presentations and/or publications with explicit written consent by the site and/or health provider.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFeasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: A pilot cluster randomised step-wedge trial.2019https://dx.doi.org/10.1016/j.addbeh.2018.10.036
EmbaseRespiratory, birth and health economic measures for use with Indigenous Australian infants in a research trial: a modified Delphi with an Indigenous panel.2020https://dx.doi.org/10.1186/s12887-020-02255-x
EmbaseSISTAQUIT: training health care providers to help pregnant Aboriginal and Torres Strait Islander women quit smoking. A cluster randomised controlled trial.2022https://dx.doi.org/10.5694/mja2.51604
N.B. These documents automatically identified may not have been verified by the study sponsor.