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Clinical Trials/NCT02642757
NCT02642757CompletedNot Applicable

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

Pontificia Universidad Catolica de Chile5 sites in 1 country342 target enrollmentStarted: December 15, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
342
Locations
5
Primary Endpoint
AUDIT score

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Brief intervention

Experimental

AUDIT brief intervention

Intervention: AUDIT brief intervention (Behavioral)

Brief intervention

Experimental

AUDIT brief intervention

Intervention: Pamphlet on alcohol use (Other)

Control group

Sham Comparator

Pamphlet on alcohol use

Intervention: Pamphlet on alcohol use (Other)

Outcomes

Primary Outcomes

AUDIT score

Time Frame: 6 months post brief intervention

Total of questions 1 to 10 (minimum 0, maximum 40)

Secondary Outcomes

  • AUDIT-C score(6 months post brief intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (5)

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