None listed
Conditions
Brief summary
The SISTAQUIT™ trial provides training to health providers (HP) at Aboriginal Medical Services (AMS) and GP practices in culturally appropriate smoking cessation care for pregnant Aboriginal and Torres Strait Islander women. Almost 1 in 2 Aboriginal and Torres Strait Islander women smoke during pregnancy. Tobacco smoking in pregnancy is the most important preventable risk factor for poor maternal and infant health outcomes, including chronic lung problems and respiratory infections. Pregnancy is an important window of opportunity for health providers to help smokers quit, however they often lack the confidence and skills to address their patients’ smoking. The SISTAQUIT intervention has been developed over many years of research including an extensive Aboriginal community consultation and co-development phase, pre-testing of resources in three states, and the recent Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy pilot study in 6 Aboriginal Medical Services (AMS) in three states (SA, NSW, QLD). The primary aim of SISTAQUIT is to assess the effectiveness of the HP training intervention at increasing smoking cessation among pregnant Indigenous smokers at 4 weeks post-baseline, compared to standard care. Secondary aims include: 1.) to increase the proportion of health providers offering assistance to pregnant Indigenous smokers; 2.) Reduce the episodes of respiratory illness and adverse perinatal outcomes in their babies (to 6 months); 3.) Conduct an economic evaluation of the intervention which includes cost-effective and cost-benefit analyses. We aim to recruit 30 AMS; 15 will be randomised to receive the intervention and 15 will be randomised to continue usual care (cluster Randomised Controlled Trial (cRCT)). The 15 AMS randomised to continue usual care will receive the intervention and SISTAQUIT resources at the end of data collection (i.e. the cluster RCT uses a ‘wait list’ control group). Each site that is formally recruited will receive reimbursement for the research activities undertaken for the trial. Ideally, all HP at each centre randomised to the intervention group will receive the SISTAQUIT smoking cessation training (as a whole of service approach). Pregnant women up to 32 weeks gestation will be invited to participate in the project; women will be followed at recruitment, 4 & 12 weeks post-recruitment, 36 weeks gestation (4 weeks before their due date), and 4 weeks & 6 months after giving birth, Their babies will also be followed for 6 months for respiratory and general health outcomes. The SISTAQUIT trial is coordinated by research staff from the University of Newcastle, and the research team includes both Indigenous and non-Indigenous investigators and research staff. The study is supported by a grant jointly funded by the Global Alliance for Chronic Disease (GACD) and the National Health and Medical Research Council (NHMRC), and supported by fellowships awarded to GGould from the NHMRC and Cancer Institute NSW.
Interventions
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 wi
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.
SISTAQUIT is a cluster randomised controlled trial (cRCT) at 21 Aboriginal Community Controlled Health Services (ACCHSs) including Aboriginal Medical Services (AMS) and at mainstream health services across Australia.
Each health service will be randomly assigned to continue usual care (10 Control sites) or receive the SISTAQUIT health provider training in culturally appropriate smoking cessation care + resources at the start of the study (11 Intervention sites).
The 10 Control sites will rece
SISTAQUIT is a cluster randomised controlled trial (cRCT) at 21 Aboriginal Community Controlled Health Services (ACCHSs) including Aboriginal Medical Services (AMS) and at mainstream health services across Australia. Each health service will be randomly assigned to continue usual care (10 Control sites) or receive the SISTAQUIT health provider training in culturally appropriate smoking cessation care + resources at the start of the study (11 Intervention sites). The 10 Control sites will receive the SISTAQUIT training + resources at the end of the study. 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 health service (especially those who provide care for pregnant women) will undertake the training. The targeted hardcopy educational resources resources include a participant booklet & flip chart, a health provider treatment manual, NRT posters and a smoking cessation algorithm mousepad all based on the ABCD model to smoking cessation. Health services in the intervention group will also receive sample packs of oral nicotine replacement therapy (NRT) and a 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.
Sponsors
The University of Newcastle
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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
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)
Outcome results
None listed