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

NCT ID: NCT02968186

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-07-31

Brief Summary

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.

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.

Conditions

Alcohol-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Implementation program

Health professionals will receive a training and support implementation program

Group Type: EXPERIMENTAL

Implementation program

Intervention Type: BEHAVIORAL

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.

Waiting list

Health professionals will be assigned to a waiting list to receive the implementation program

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cambridge

OTHER

Sponsor Role: collaborator

University of Stirling

OTHER

Sponsor Role: collaborator

Université Catholique de Louvain

OTHER

Sponsor Role: collaborator

Agrupamento de Centros de Saúde de Dão Lafões

OTHER

Sponsor Role: lead

Responsible Party

Frederico Rosário

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederico M Rosário, MD

Role: PRINCIPAL_INVESTIGATOR

Dão Lafões Grouping of Primary Health Care Centres

Locations

Dão Lafões Grouping of Primary Health Care Centres

Viseu, Dão Lafões, Portugal

Countries

Portugal

References

Rosario F, Vasiljevic M, Pas L, Fitzgerald N, Ribeiro C. Implementing alcohol screening and brief interventions in primary health care: study protocol for a pilot cluster randomized controlled trial. Fam Pract. 2019 Mar 20;36(2):199-205. doi: 10.1093/fampra/cmy062.

Reference Type: BACKGROUND

PMID: 29939239 (View on PubMed)

Other Identifiers

ASBI-2017

Identifier Type: -

Identifier Source: org_study_id