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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02968186
Other study ID # ASBI-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date July 2018

Study information

Verified date January 2020
Source Agrupamento de Centros de Saúde de Dão Lafões
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date July 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Portugal Dão Lafões Grouping of Primary Health Care Centres Viseu Dão Lafões

Sponsors (4)

Lead Sponsor Collaborator
Agrupamento de Centros de Saúde de Dão Lafões Université Catholique de Louvain, University of Cambridge, University of Stirling

Country where clinical trial is conducted

Portugal, 

References & Publications (1)

Rosário 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol screening rate 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 Improvement of general practitioners attitudes toward at-risk drinkers 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
Secondary Improvement in knowledge related to alcohol screening and brief intervention 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
Secondary Improvement in barriers for implementing alcohol screening and brief intervention 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
Secondary Utility of materials used in the trial 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
Secondary Brief intervention rate Percentage of patients who screened positive that were offered at least one brief intervention 12 months
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