Alcohol Brief Counseling in Primary Care

Not Applicable

Completed

• Conditions: Alcohol Drinking
• Interventions: Behavioral: AUDIT brief intervention; Other: Pamphlet on alcohol use

• Registration Number: NCT02642757
• Lead Sponsor: Pontificia Universidad Catolica de Chile

Brief Summary

This study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. Half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.

Detailed Description

Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.

The brief intervention has been designed and piloted by the mental health team at the Chilean ministry of health, as also the written support material. This intervention is the same that is being implemented national wide.

The implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror.

Randomization will take place on site using a opaque envelope. The sequence will be keep on site in a secured box.

Data will be registered by the same person delivering the intervention and kept safe at the clinical sites. Once a month the data will be physically transferred to the operational center at the San Joaquin site of the Catholic University of Chile.

Bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit.

The participants will receive an economical incentive for the follow up visit. Participants will be reached throw telephone at least twice to schedule that visit. If not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.

Study Timeline

• Study Start: 2015-12-15
• Study First Submitted: 2015-12-28
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Primary Completion: 2017-07-30
• Study Completion: 2017-07-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

• AUDIT score between 8 and 15
• Able to read
• Haven't received a similar intervention in the last 3 months

Exclusion Criteria

• Clients in treatment for alcohol use disorder
• Alcohol use treatment seekers
• Pregnant woman
• Severe physical or psychiatric pathology not stable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brief intervention	Pamphlet on alcohol use	AUDIT brief intervention
Brief intervention	AUDIT brief intervention	AUDIT brief intervention
Control group	Pamphlet on alcohol use	Pamphlet on alcohol use

Primary Outcome Measures

Name	Time	Method
AUDIT score	6 months post brief intervention	Total of questions 1 to 10 (minimum 0, maximum 40)

Secondary Outcome Measures

Name	Time	Method
AUDIT-C score	6 months post brief intervention	Total of questions 1 to 3 (minimum 0, maximum 12)

Trial Locations

Locations (5)

CESFAM Juan Pablo II; 🇨🇱 Santiago, Metropolitana, Chile

CESFAM San Alberto Hurtado; 🇨🇱 Santiago, Puente Alto, Chile

CESFAM Madre Teresa de Calcuta; 🇨🇱 Santiago, Puente Alto, Chile

CESFAM Barros Luco; 🇨🇱 Santiago, San Miguel, Chile

CESFAM Recreo; 🇨🇱 Santiago, San Miguel, Chile