Clinical trial NCT03506867: Healthy People Initiative (HPI)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Nicotine Dependence
Substance Use Disorders
Keywords: Health Equity
Community Based Participatory Action Research
Poverty Reduction
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 250
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

Brief summary: Addictions do not occur in isolation. Tackling addictions requires addressing social determinants such as isolation, homelessness, marginalization, and unemployment. Research on individuals living with or at risk for HIV/AIDS highlights that unemployment correlates with higher levels of depression, anxiety, and social isolation compared to employment. In Ottawa, the PROMPT project engaged homeless or at-risk populations, including people who use drugs and those living with or at risk for HIV/AIDS or Hepatitis C using the Bridge ModelTM, a pragmatic community-based participatory action research approach operationalized through earlier projects at the Bridge Engagement Center in Ottawa, Canada. The PROMPT project demonstrated that implementing multi-component, complex interventions is both feasible and effective, achieving broader socio-economic outcomes beyond reduction and quitting tobacco and poly-substance use. However, PROMPT participants identified a lack of social and recovery capital -family and social connections, opportunities for volunteering and jobs- as a major barrier to recovery. To address this, we conducted a six-month feasibility pilot study with 20 PROMPT participants. By its conclusion, 15 participants were engaged in small paid or volunteer roles, including educational opportunities, fostering both social integration and recovery. Insights from this pilot study informed the design of a larger community-based multi-site pragmatic randomized trial (RCT) to further evaluate the effectiveness of the Bridge ModelTM, the Healthy People Initiative (HPI) project. The Healthy People Initiative (HPI) is a community-based, participatory, pragmatic parallel-arm multi-site with a cross-over design, recruiting 250 participants (16+) at risk of homelessness or low socioeconomic status in Ottawa and Toronto, Canada.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Self-Reported Quality of Life
timeFrame: 6 Months
Secondary outcomes:
measure: Self-Reported Efficacy
timeFrame: 12 months
measure: Tobacco use
timeFrame: 12 months
Other outcomes:
measure: Consent and Protocol Violation Rate
timeFrame: 12 months
measure: Healthcare Utilization Rate
timeFrame: 12 months
measure: Access to Work, Training, and Volunteer Opportunities
timeFrame: 12 months
measure: Costs of Poverty Reduction Intervention
timeFrame: 12 months
measure: Average Recruitment Rate
timeFrame: 12 months
measure: Poly-substance use rates
timeFrame: 12 months
Locations:
city: Ottawa
country: Canada
facility: The Bridge Engagement Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Smita Pakhalé, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: