Which Way? Quit Pack study protocol: a national hybrid type 2 effectiveness-implementation study of mailed smoking
Kade Booth1,2, Jamie Bryant3,4, Kayden Roberts-Barker5,2
1The University of Newcastle, Callaghan, New South Wales, Australia k.booth@newcastle.edu.au.
Introduction:
Mailed smoking and vaping cessation support provided through the Which Way? Quit Pack programme has demonstrated acceptability and preliminary effectiveness in delivering culturally grounded support. However, there is no evidence of the effectiveness of mailed cessation programmes for Aboriginal and Torres Strait Islander people when implemented on a national scale. Building on previous work, this study aims to evaluate both the implementation effectiveness and cost-effectiveness analysis of the Which Way? Quit Pack mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander people.
Methods And Analysis:
A national single-group hybrid type 2 effectiveness-implementation study with 2000 Aboriginal and/or Torres Strait Islander people who use cigarettes and/or e-cigarettes (vapes) daily, want to quit and are aged ≥18 years. Participants will receive access to a culturally tailored mailed quit pack that includes up to a 12-week supply of nicotine replacement therapy, phone-based behavioural counselling and access to an online support forum. Cessation outcomes including 7-day point prevalence abstinence, prolonged abstinence and quit rates will be evaluated at 3, 6 and 12 months. An intention-to-treat approach will be used for cessation outcomes, with participants lost to follow-up classified as smokers or vapers. Exploratory logistic regression analyses will examine factors associated with quitting, and causal machine learning methods will be used to explore variation in intervention effectiveness across participant subgroups. The Reach-Effectiveness-Adoption-Implementation-Maintenance framework will guide evaluation of implementation and effectiveness outcomes. Analysis measures include cessation and quit attempt rates, number of participants recruited, representativeness and intervention uptake. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) will guide the cost-effectiveness analysis.
Ethics And Dissemination:
This study is governed by Aboriginal and Torres Strait Islander leadership and community-controlled partnerships and is conducted in line with Indigenous data sovereignty and Indigenous research ethics principles. The study has also received approval from the following human research ethics committees: Aboriginal Health & Medical Research Council of NSW (2493/25), Aboriginal Health Committee South Australia (04-25-1209), the Western Australian Aboriginal Health (HREC1474), the Victorian Aboriginal Community Controlled Health Organisation (2025/HREC0061) and the University of Newcastle Human Research (H-2025-0311). Findings will be disseminated in forms determined, governed and endorsed by Aboriginal and Torres Strait Islander people and communities through the project Governance, including peer-reviewed publications, policy briefs, community-led knowledge translation activities and presentations at local, national and international conferences.
Trial Registration Number:
ACTRN12626000459325.
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