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

NCT07228923 — Not applicable, Completed, 77 participants, Centre for Addiction and Mental Health

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Evaluation of a Theory Informed Intervention to Reduce Hazardous Alcohol Consumption Among Treatment Seeking Smokers

RegistryNCT07228923
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment77 (Actual)
SponsorCentre for Addiction and Mental Health (Other)
ConditionsAlcohol Misuse
InterventionsBrief alcohol intervention (Behavioral)
Datesstart 2025-11-20, primary completion 2026-05-22, completion 2026-05-22, first posted 2025-11-14, last updated 2026-06-11
Locations1 site in Canada

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Patient Portal PromptExperimentalBehavioral: Brief alcohol interventionBrief Alcohol Intervention
  • Brief alcohol intervention (Behavioral): The intervention is a prompt that that appears as an alert message in the patient portal, recommending the alcohol intervention.

+Outcome measures

Primary outcomes

  • overall acceptance rate [Immediate: acceptance of offered intervention during baseline survey data collection (following eligibility determination in same survey).]

Secondary outcomes

  • Provider-initiated discussion of alcohol use at the first clinical treatment visit [Assessed at the first clinical visit within 2 months after baseline survey completion.]: Provider-initiated discussion of alcohol use at the first clinical treatment visit. Following self-enrolment, providers reviewed participant questionnaires prior to or during the first visit and were asked to record whether they had discussed alcohol use with the participant. This outcome is captured via the portal data-collection system.

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

* none

+Locations (1)

FacilityCityCountryStatus
Centre for Addiction and Mental HealthToronto, OntarioCanada

+Study documents

My Notes