Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care

January 9, 2020 updated by: Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões
The objective of this study is to investigate the efficacy of an implementation program specifically designed to increase alcohol screening and brief intervention rates in primary health care.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Alcohol is an important risk factor for several diseases, even when consumed moderately. Screening and advising at-risk drinkers to cut-down is a highly effective and cost-effective intervention when conducted in primary healthcare settings. However, these interventions are seldom implemented at the primary care level.

Twelve out of the 26 primary health care units of the Dão Lafões Grouping of Primary Health Care Centres will be randomized to two groups: the intervention arm will receive the new implementation program; the control group will be on a waiting list for receiving the implementation program and will receive the intervention after the testing phase of the trial is completed. The study will last for one year, starting in January 2017. The implementation program was designed in order to overcome known barriers for implementing alcohol screening and brief advice in primary health care. The Behaviour Change Wheel and the Theoretical Domains Framework were used to pinpoint the constructs and behaviour change techniques most suited to address the barriers in order to achieve practice changes.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Dão Lafões
      • Viseu, Dão Lafões, Portugal, 3514-511
        • Dão Lafões Grouping of Primary Health Care Centres

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary health care units of the Dão Lafões Grouping of Primary Health Care Centres (family physicians/general practitioners, family medicine residents, practice nurses and receptionists)

Exclusion Criteria:

  • Primary health care units with four or less general practitioners
  • Primary health care units that have a specific alcohol program already implemented

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation program
Health professionals will receive a training and support implementation program
Health professionals in the intervention arm will receive up to four training sessions in the first three months of the implementation period. Practice support will be continuously available throughout the project. Posters specifically designed for this project will be added to the primary health care units aiming to facilitate eliciting alcohol issues during the consultations, and to help professionals remembering to conduct alcohol screening and brief intervention. Leaflets to be handed-in to patients were also specifically produced for this project, aiming to aid professionals in advising at-risk drinkers to cut down. The research team will schedule with each primary health care unit regular visits for feedback on the progress of the program.
No Intervention: Waiting list
Health professionals will be assigned to a waiting list to receive the implementation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol screening rate
Time Frame: 12 months
Percentage of eligible patients visiting the primary health care centre for an appointment with a general practitioner or nurse who were screened for alcohol use with the Alcohol Use Disorders Identification Test
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of general practitioners attitudes toward at-risk drinkers
Time Frame: 12 months
Short Alcohol and Alcohol Problems Perception Questionnaire given before and after intervention. General practitioners are classified into a more positive or more negative attitudes group based on the answers given. The groups will be compared before and after.
12 months
Improvement in knowledge related to alcohol screening and brief intervention
Time Frame: 12 months
Four multiple choice questions. These questions will measure the theoretical knowledge of health professionals to key concepts related to alcohol screening and brief intervention. The groups will be compared before and after.
12 months
Improvement in barriers for implementing alcohol screening and brief intervention
Time Frame: 12 months
Level of agreement with 33 statements. Each statement can be mapped to a specific domain of the Theoretical Domains Framework. The groups will be compared before and after.
12 months
Utility of materials used in the trial
Time Frame: Through study completion, an average of 12 months
Level of agreement with 6 statements. Participants (intervention arm only) will be asked to rate the impact of the materials that were specifically produced to be used during the trial.
Through study completion, an average of 12 months
Brief intervention rate
Time Frame: 12 months
Percentage of patients who screened positive that were offered at least one brief intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Frederico M Rosário, MD, Dão Lafões Grouping of Primary Health Care Centres

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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