Healthy People Initiative (HPI)

Title of Trial: A Healthy People Initiative (HPI) - Community-Based Participatory Action Pragmatic Parallel Arm Multi-Site Randomized Controlled Trial using The Bridge ModelTM in Systemically Disadvantaged Populations: HPI Trial Protocol

Short Title of Trial: HPI Trial

Principal Investigator: Smita Pakhalé

Trial Sites: Ottawa (The Bridge Engagement Centre) & Toronto (Parkdale Activity Recreation Centre)

Primary outcome: The Healthy People Initiative (HPI) randomized controlled trial (RCT) builds on the pilot study to evaluate changes in participants' self-reported quality of life (QoL) as the primary outcome while implementing the Bridge Model™ approach to address tobacco management.

Secondary outcomes: The secondary objective is to quantify reductions in tobacco use and quitting tobacco use altogether, with quit rates validated biochemically, and changes in self-efficacy.

Tertiary outcomes: These include evaluating process-related metrics such as participant enrolment rates, consent rates, and adherence to protocol; estimating implementation costs to guide future cost-effectiveness analyses; and assessing additional patient-reported outcomes such as self-efficacy, participation in education or employment, and reductions in polysubstance use. Additionally, a cost-utility analysis from a health system perspective will assess the economic impact of the 52-week intervention by measuring total costs and healthcare utilization, linking trial data to administrative health records. We aim to provide robust evidence to support the utility of the Bridge ModelTM in addressing health and social inequities through community-driven, peer-led interventions that integrate social determinants with individual health outcomes.

Primary Objective: To assess the feasibility of a randomized controlled trial investigating access to improvements in 'social capital' in the low income population in Ottawa and Toronto.

Study Design & Population: The HPI study is a crossover, community-based, multi-site pragmatic RCT (1:1 allocation ratio) in Ottawa and Toronto. It uses a 12-month follow-up to evaluate short- and long-term effects of the intervention on health, social, and economic outcomes. Data sources include self-reports, biochemical validation, and administrative health records

Sample Size: 250

Trial Arms: The HPI RCT has two arms: usual care and intervention (Figure 1). The intervention arm employs the Bridge ModelTM, offering life-skills workshops, social integration, peer guidance, system navigation (e.g., housing), and APN (Advanced Practice Nurse) or NP (Nurse Practitioner) counselling, including primary care, preventive services, and referrals. Both arms receive monthly follow-ups from peers and APN/NP. Usual care includes resource information and counselling, with an option to switch to the intervention arm after six months. All participants receive nicotine replacement therapy (NRT) for 12 months as needed.

Trial Duration: 12 months Follow-up Duration: 12 months

Inclusion criteria

• Participants must be 16 years or older, reside in Ottawa or Toronto,
• Have smoked tobacco in the past 7 days
• Identify as low socioeconomic status and/or at risk of homelessness, and be available for in-person follow-up for one year.

Exclusion criteria

• Declining consent
• Any person who is in or planning on accessing addictions treatment (in-patient drug rehabilitation) in Ottawa or Toronto and hence will be unavailable for follow up
• Currently or recently (in the past 30 days) enrolled in any other smoking cessation program