Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
Primary Purpose
Alcohol-Related Disorders
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Implementation program
Sponsored by
About this trial
This is an interventional health services research trial for Alcohol-Related Disorders focused on measuring Mass Screening, Counseling, Primary Health Care
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
Sites / Locations
- Dão Lafões Grouping of Primary Health Care Centres
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Implementation program
Waiting list
Arm Description
Health professionals will receive a training and support implementation program
Health professionals will be assigned to a waiting list to receive the implementation program
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
Brief intervention rate
Percentage of patients who screened positive that were offered at least one brief intervention
Full Information
NCT ID
NCT02968186
First Posted
November 16, 2016
Last Updated
January 9, 2020
Sponsor
Agrupamento de Centros de Saúde de Dão Lafões
Collaborators
University of Cambridge, University of Stirling, Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02968186
Brief Title
Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
Official Title
Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Agrupamento de Centros de Saúde de Dão Lafões
Collaborators
University of Cambridge, University of Stirling, Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders
Keywords
Mass Screening, Counseling, Primary Health Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
222 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Implementation program
Arm Type
Experimental
Arm Description
Health professionals will receive a training and support implementation program
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Health professionals will be assigned to a waiting list to receive the implementation program
Intervention Type
Behavioral
Intervention Name(s)
Implementation program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol screening rate
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement of general practitioners attitudes toward at-risk drinkers
Description
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.
Time Frame
12 months
Title
Improvement in knowledge related to alcohol screening and brief intervention
Description
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.
Time Frame
12 months
Title
Improvement in barriers for implementing alcohol screening and brief intervention
Description
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.
Time Frame
12 months
Title
Utility of materials used in the trial
Description
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.
Time Frame
Through study completion, an average of 12 months
Title
Brief intervention rate
Description
Percentage of patients who screened positive that were offered at least one brief intervention
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederico M Rosário, MD
Organizational Affiliation
Dão Lafões Grouping of Primary Health Care Centres
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dão Lafões Grouping of Primary Health Care Centres
City
Viseu
State/Province
Dão Lafões
ZIP/Postal Code
3514-511
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29939239
Citation
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.
Results Reference
background
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Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
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