Alcohol Brief Counseling in Primary Care

Alcohol Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642757
• Other study ID #: 14-214
• Secondary ID: SM14I0033
• Status: Completed
• Phase: N/A
• Start date: December 15, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: May 2019
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking

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.

Locations

Country	Name	City	State
Chile	CESFAM Barros Luco	Santiago	San Miguel
Chile	CESFAM Juan Pablo II	Santiago	Metropolitana
Chile	CESFAM Madre Teresa de Calcuta	Santiago	Puente Alto
Chile	CESFAM Recreo	Santiago	San Miguel
Chile	CESFAM San Alberto Hurtado	Santiago	Puente Alto

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUDIT score	Total of questions 1 to 10 (minimum 0, maximum 40)	6 months post brief intervention
Secondary	AUDIT-C score	Total of questions 1 to 3 (minimum 0, maximum 12)	6 months post brief intervention