Healthy People Initiative (HPI) (HPI)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Substance Use Disorders; Nicotine Dependence
• Intervention / Treatment: Behavioral: Life skills, training, education and work/volunteer opportunities; Behavioral: Usual Care

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

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1K 4B7
      • The Bridge Engagement Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care arm; We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.	Behavioral: Life skills, training, education and work/volunteer opportunities; Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).
Active Comparator: Life skills, training, education and work/volunteer opportunities, and peer support; The life skills, training, education, work/volunteer opportunities, and peer support arm will be offered to the usual care arm participants after the first six months of study enrollment.	Behavioral: Usual Care; We will provide the participants in this arm with pamphlets and knowledge about available services in the city through partner agencies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Quality of Life	To assess the trend in self-reported quality of life using the European Quality of Life 5 Dimensions 5 Level Version.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Efficacy	To estimate change in self-reported self-efficacy.	12 months
Tobacco use	To estimate self-reported reduced or quit tobacco use rate (corroborated with the measurement of exhaled Carbon Monoxide) and poly-substance use rate.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Recruitment Rate	To assess the ability of participating sites to enroll an average of 6 participants per month.	12 months
Consent and Protocol Violation Rate	The consent rate of eligible participants and the rate of protocol violations resulting in cross contamination of the groups receiving study intervention	12 months
Costs of Poverty Reduction Intervention	To estimate the costs of poverty reduction intervention (life skills workshops, training, and education/volunteer/employment opportunities.	12 months
Healthcare Utilization Rate	To compare healthcare utilization (ER visits and hospitalizations) over one year before and after the study by linking the trial data to health administrative data available at the Institute for Clinical and Evaluative Sciences (ICES).	12 months
Access to Work, Training, and Volunteer Opportunities	To assess access to work, training, or volunteering positions using a self-reported online survey.	12 months
Poly-substance use rates	Reductions in polysubstance use (biochemically validated)	12 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Smita Pakhalé, MD, MSc, The Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2019
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Estimated): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Health Equity; Community Based Participatory Action Research; Poverty Reduction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 20180274-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request study de-identified data will be made available to interested and qualified researchers.
• IPD Sharing Time Frame: Upon request study de-identified data will be made available to interested and qualified researchers. No time frame necessary.
• IPD Sharing Access Criteria: No access criteria. De-identified raw data will be available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No