Alcohol Brief Counseling in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Alcohol Drinking

Intervention / Treatment
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* Behavioral: AUDIT brief intervention
* Other: Pamphlet on alcohol use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief intervention<br>AUDIT brief intervention | Behavioral: AUDIT brief intervention<br>* 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.<br>Other: Pamphlet on alcohol use<br>* 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.<br>|
| Sham Comparator: Control group<br>Pamphlet on alcohol use | Other: Pamphlet on alcohol use<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol drinking, hazardous alcohol use, risky alcohol consumption, heavy alcohol consumption