The PROMPT Pilot Study

Study Overview
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Brief Summary
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The PROMPT Pilot Study is a feasibility mixed methods prospective cohort study following principles of community-based participatory action research. The study recruited 80 people who use drugs and followed them for 6 months while providing access to counselling, nicotine replacement therapy and peer-support in a community setting. A notable reduction in average cigarette use per day (20.5 to 9.3) and illicit substance use (18.8%) was observed at study-end. PROMPT's patient engagement model is an effective harm-reduction strategy for the growing opioid use crisis and can improve the health outcomes of marginalised at-risk populations worldwide.

Detailed Description
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Objective To determine the feasibility of a Community-Based Participatory Tobacco Dependence Strategy (PROMPT) in the inner city population of Ottawa (Canada). Design A feasibility mixed methods prospective cohort study following principles of community-based participatory action research. Intervention Recruited 80 people who use drugs, followed them for 6 months while providing access to counseling, nicotine replacement therapy and peer-support in a community setting. Setting Community research office in downtown Ottawa, adjacent to low-income housing, shelter services and street-based drug consumption. Primary outcome Retention rate at 6-month follow-up. Secondary outcome Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm.

Official Title
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Management and Point-of-Care for Tobacco Dependence (PROMPT): a Feasibility Mixed Methods Community-based Participatory Action Research Project in Ottawa, Canada

Conditions
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Tobacco Use Disorder, Tobacco Dependence, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Smoking Cessation Counselling
* Drug: Nicotine Replacement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: currently living in Ottawa for at least 3 months prior to enrolment 16 years or older have used drugs in the past year (excluding marijuana and alcohol) have smoked tobacco in the past 7 days Exclusion Criteria: consent declined (refusal from participant or decision maker) any person accessing addictions treatment (in-patient drug rehabilitation) and hence unavailable for follow-up any person currently or recently (in the past 30 days) enrolled in a smoking cessation program anyone with a terminal illness with a life expectancy of <3 months.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PROMPT Participants<br>80 participants who are homeless or at-risk for homelessness, smoke tobacco, and identify as People Who Use Drugs in Ottawa. | Behavioral: Smoking Cessation Counselling<br>* One on one smoking cessation counselling with a certified mental health nurse<br>Drug: Nicotine Replacement Therapy<br>* Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of Study Participants | Retention rate at 6-month follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical Validation of Smoking Cessation Outcome | Biochemically validated 7-day point prevalence smoking abstinence at 26 weeks, self-reported abstinence in the past 7 days with exhaled carbon monoxide ≤10 ppm. | 6 months |