NCT07228923

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Nov 2025Dec 2026

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 20, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Smoking CessationAlcoholBrief InterventionSBIRT

Outcome Measures

Primary Outcomes (1)

  • overall acceptance rate

    Data will be collected at baseline

Study Arms (1)

Patient Portal Prompt

EXPERIMENTAL

Brief Alcohol Intervention

Behavioral: Brief alcohol intervention

Interventions

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

Patient Portal Prompt

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking Cessation

Interventions

EthanolMethods

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

November 20, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11