Clinical trial NCT02642757: Alcohol Brief Counseling in Primary Care
Official title: Effectiveness of a Brief Intervention for Reducing the Alcohol Use in Risky Users Delivered by Paramedics in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Keywords: alcohol drinking
hazardous alcohol use
risky alcohol consumption
heavy alcohol consumption
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUDIT score
timeFrame: 6 months post brief intervention
Secondary outcomes:
measure: AUDIT-C score
timeFrame: 6 months post brief intervention
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: CESFAM Juan Pablo II
state: Metropolitana
city: Santiago
country: Chile
facility: CESFAM San Alberto Hurtado
state: Puente Alto
city: Santiago
country: Chile
facility: CESFAM Madre Teresa de Calcuta
state: Puente Alto
city: Santiago
country: Chile
facility: CESFAM Barros Luco
state: San Miguel
city: Santiago
country: Chile
facility: CESFAM Recreo
state: San Miguel
Study officials:
affiliation: Instructor Professor
name: Nicolas Barticevic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barticevic NA, Poblete F, Zuzulich SM, Rodriguez V, Quevedo D, Sena BF, Bradshaw L. A Health Technician-delivered Brief Intervention linked to AUDIT for reduction of alcohol use in Chilean primary care: a randomized controlled trial. Addict Sci Clin Pract. 2021 Jun 15;16(1):39. doi: 10.1186/s13722-021-00248-4.