- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02968186
Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Dão Lafões
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Viseu, Dão Lafões, Portugal, 3514-511
- Dão Lafões Grouping of Primary Health Care Centres
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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No Intervention: Waiting list
Health professionals will be assigned to a waiting list to receive the implementation program
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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
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12 months
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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
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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
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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.
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Through study completion, an average of 12 months
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Brief intervention rate
Time Frame: 12 months
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Percentage of patients who screened positive that were offered at least one brief intervention
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12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frederico M Rosário, MD, Dão Lafões Grouping of Primary Health Care Centres
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASBI-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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