The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy

Abstract

IntroductionIndigenous 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 analysisThis 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 disseminationIn 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 detailsThis protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN 12616001603404).

Coming together for something good: recommendations from a scoping review for dissemination and implementation science to improve indigenous substance use disorder treatment

“…Out of the 20 studies reviewed, ten (50%) of them reported outcomes related to intervention effectiveness ( 1 , 34 , 36 , 38 , 40 , 41 , 45 , 48–50 ). There were several studies where the primary outcome was tobacco cessation [ n = 7; ( 32 , 36 , 38 , 45 , 47–49 )]. In a tobacco cessation program for pregnant Aboriginal women, self-reported 12-week 7-day point-prevalence abstinence was 13.6% ( 38 ).…”

“…Sixty percent of the studies described processes and outcomes related to Adoption [ n = 12; ( 1 , 32 , 36–38 , 40–42 , 44 , 47–49 )]. At the staff level, authors highlighted strategies, for and barriers to, Adoption.…”

“…Including enhancements to Adoption focused on the staff members themselves. While some studies had specific inclusion and exclusion criteria for staff ( 32 , 38 , 48 ), Indigenous staff and level of staff buy-in were highlighted as the key to increasing Adoption ( 37 , 41 , 44 ). The duration of the intervention also impacted Adoption.…”

Protocol for iSISTAQUIT: Implementation phase of the supporting indigenous smokers to assist quitting project

“…The iSISTAQUIT program has been adapted from foundation work established by a pilot project called ICAN (Indigenous Counselling and Nicotine) QUIT in Pregnancy (Phase 2) that was developed and trialled in six Aboriginal Community-Controlled Health Organisations (ACCHOS) with the aim of training HCPs in culturally sensitive smoking cessation assistance to pregnant Aboriginal and Torres Strait Islander women who smoke, [28][29][30] as well as the SISTAQUIT Randomised Controlled Trial (Phase 3) [31]. This is intervention built on extensive formative research into pregnant Aboriginal and Torres Strait Islander women who smoke and health professional delivery of smoking cessation care [10,[32][33][34][35][36][37][38][39][40].…”