Development and Evaluation of a Theory and Evidence-based Intervention to Reduce Hazardous Alcohol Consumption Among Treatment Seeking Smokers

NCT ID: NCT07228923

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-20
• Study Completion Date: 2026-12-31

Brief Summary

This study will evaluate the implementation of a fully automated, direct-to-patient digital alcohol intervention embedded within the STOP Program's patient portal. The STOP Program is a large-scale, population-based smoking cessation initiative operating in over 300 primary care settings across Ontario. It provides free nicotine replacement therapy and behavioural support through a digital portal that facilitates patient self-enrollment and systematic data collection. As part of this study, patients who score ≥8 on the AUDIT-C will be offered the opportunity to view a brief intervention (BI). Those with an AUDIT-C score ≥10 will receive a cautionary message along with tailored content designed to help reduce hazardous drinking.

The intervention was developed based on a rapid review (PROSPERO: CRD42023445492) and a Delphi consensus process using the Behaviour Change Techniques Taxonomy V1. Key components include personalized feedback, normative comparisons, reflective prompts, and actionable behaviour change strategies. For patients scoring above a clinical threshold, additional messaging encourages caution regarding abrupt cessation and suggests consulting a healthcare provider.

Our primary outcome is acceptance of the new online resource.

Conditions

Alcohol Misuse

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient Portal Prompt

Brief Alcohol Intervention

Group Type: EXPERIMENTAL

Brief alcohol intervention

Intervention Type: BEHAVIORAL

The intervention is a prompt that that appears as an alert message in the patient portal, recommending the alcohol intervention.

Interventions

Brief alcohol intervention

The intervention is a prompt that that appears as an alert message in the patient portal, recommending the alcohol intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• seeking treatment for smoking cessation
• enrolling via the patient self-serve portal
• AUDIT-10 score of 8 or higher

Exclusion Criteria

• none

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DCP-196026

Identifier Type: -

Identifier Source: org_study_id