The PROMPT Pilot Study

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Tobacco Use Cessation; Tobacco Dependence
• Intervention / Treatment: Behavioral: Smoking Cessation Counselling; Drug: Nicotine Replacement Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PROMPT Participants; 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; One on one smoking cessation counselling with a certified mental health nurse; Drug: Nicotine Replacement Therapy; Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• Pakhale S, Visentin C, Tariq S, Kaur T, Florence K, Bignell T, Jama S, Huynh N, Boyd R, Haddad J, Alvarez GG. Lung disease burden assessment by oscillometry in a systematically disadvantaged urban population experiencing homelessness or at-risk for homelessness in Ottawa, Canada from a prospective observational study. BMC Pulm Med. 2022 Jun 16;22(1):235. doi: 10.1186/s12890-022-02030-x.
• Pakhale S, Tariq S, Huynh N, Jama S, Kaur T, Charron C, Florence K, Nur F, Bustamante-Bawagan ME, Bignell T, Boyd R, Haddad J, Kendzerska T, Alvarez G. Prevalence and burden of obstructive lung disease in the urban poor population of Ottawa, Canada: a community-based mixed-method, observational study. BMC Public Health. 2021 Jan 21;21(1):183. doi: 10.1186/s12889-021-10209-w.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 20140333-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available to researchers that contact the Principal Investigator.
• IPD Sharing Time Frame: Data will be available upon request for the period decided necessary by the Principal Investigator and the inquiring researcher or researchers.
• IPD Sharing Access Criteria: Will provide access in the manner decided by Principal Investigator and the inquiring researcher or researchers.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

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