Alcohol Brief Counseling in Primary Care

May 20, 2019 updated by: Pontificia Universidad Catolica de Chile

Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

342

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Metropolitana
      • Santiago, Metropolitana, Chile
        • CESFAM Juan Pablo II
    • Puente Alto
      • Santiago, Puente Alto, Chile, 8181297
        • CESFAM San Alberto Hurtado
      • Santiago, Puente Alto, Chile
        • CESFAM Madre Teresa de Calcuta
    • San Miguel
      • Santiago, San Miguel, Chile
        • CESFAM Barros Luco
      • Santiago, San Miguel, Chile
        • CESFAM Recreo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief intervention
AUDIT brief intervention
Behavioral: AUDIT brief intervention
Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.
Other: Pamphlet on alcohol use
Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.
Sham Comparator: Control group
Pamphlet on alcohol use
Other: Pamphlet on alcohol use
Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUDIT score
Time Frame: 6 months post brief intervention
Total of questions 1 to 10 (minimum 0, maximum 40)
6 months post brief intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUDIT-C score
Time Frame: 6 months post brief intervention
Total of questions 1 to 3 (minimum 0, maximum 12)
6 months post brief intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Nicolas Barticevic, MD, Instructor Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 15, 2015

Primary Completion (Actual)

July 30, 2017

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

December 28, 2015

First Submitted That Met QC Criteria

December 29, 2015

First Posted (Estimate)

December 30, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-214
  • SM14I0033 (Other Grant/Funding Number: FONIS Chile)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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