Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption

Summary

* Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC).
* Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.

Conditions

• Alcohol Consumption
• Alcohol Use Disorder

Interventions

BEHAVIORAL

Motivational interview

The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program

BEHAVIORAL

Medical advice

Usual care

Sponsors & Collaborators

• Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)

  collaborator UNKNOWN

• Progress and Health Foundation

  collaborator UNKNOWN

• Córdoba and Guadalquivir Health District

  collaborator UNKNOWN

• Hospital Universitario Reina Sofia de Cordoba

  lead OTHER_GOV

Principal Investigators

• Jose Angel Fernández García, Doctor · Andaluz Health Service

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-18

Primary Completion

2023-04-01

Completion

2023-07-30

Countries

• Spain

Study Locations