Alcohol-Related DisordersNCT02968186
Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
A study testing Implementation program in people with Alcohol-Related Disorders, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders
- What is being tested?
- Implementation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 sitePortugal
- Study dates
- Nov 2016to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Primary health care units with four or less general practitioners
- Primary health care units that have a specific alcohol program already implemented
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Dão Lafões Grouping of Primary Health Care Centres
Viseu, Dão Lafões, 3514-511
About this study
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.
Read the 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
- Being tested
- Implementation program
- Keywords
- Mass Screening, Counseling, Primary Health Care
- Medical subject headings
- Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Implementation program | Experimental | Health professionals will receive a training and support implementation program Receives: Behavioral: Implementation program |
| Waiting list | No intervention | Health professionals will be assigned to a waiting list to receive the implementation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: Through study completion, an average of 12 months
Brief intervention rate
Percentage of patients who screened positive that were offered at least one brief intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão Lafões
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Stirling, Université Catholique de Louvain
- Responsible party
- Principal investigator, Frederico Rosário, Agrupamento de Centros de Saúde de Dão Lafões
- Investigators
- Frederico M Rosário, MD, Principal investigator, Dão Lafões Grouping of Primary Health Care Centres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968186
- Sponsor's protocol ID
- ASBI-2017
- Status last verified
- Jan 2020
- First submitted
- 16 Nov 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29939239
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Screening and Brief Interventions for Excessive Drinkers in Primary Health Care
- ClinicalTrials.gov ID
- NCT02968186
- Acronym / sponsor ID
- ASBI-2017
- Conditions
- Alcohol-Related Disorders
- Keywords
- Mass Screening, Counseling, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Agrupamento de Centros de Saúde de Dão LafõesUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Stirling, Université Catholique de Louvain
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 18 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation program | Experimental | Behavioral: Implementation programHealth professionals will receive a training and support implementation program |
| Waiting list | No intervention | –Health professionals will be assigned to a waiting list to receive the implementation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (2 listed)
- Primary health care units with four or less general practitioners
- Primary health care units that have a specific alcohol program already implemented
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation programHealth 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. | Behavioural | Implementation program |
Primary outcome
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
5 secondary outcomes
Improvement of general practitioners attitudes toward at-risk drinkers
Time frame: 12 months
Improvement in knowledge related to alcohol screening and brief intervention
Time frame: 12 months
Improvement in barriers for implementing alcohol screening and brief intervention
Time frame: 12 months
Utility of materials used in the trial
Time frame: Through study completion, an average of 12 months
Brief intervention rate
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 29939239Rosario 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.
- Individual participant dataSharing planned: No
Related trials for Alcohol-Related Disorders
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Investigation of the Gut-Brain Axis in Alcohol Use Disorder
Alcohol Use Disorder (AUD), Alcohol Abstinence
Not yet recruiting
Multimodal Intervention for Individuals With Posttraumatic Stress Disorder (PTSD) and Hazardous Alcohol Use
Post Traumatic Stress Disorder PTSD, Hazardous Alcohol Use
Active, not recruiting
Leveraging Virtual Care Strategies to Improve Access and Treatment for Individuals With Alcohol Use Disorders
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederico M Rosário, MD principal investigator
Dão Lafões Grouping of Primary Health Care Centres
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation program in people with Alcohol-Related Disorders, run by Agrupamento de Centros de Saúde de Dão Lafões at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol screening rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.