- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398576
Primary Care Implementation Study to Scale up EIBI and Reduce Alcohol Related Negative Outcomes (PINO)
Primary Care Implementation Study to Scale up Early Identification and Brief Interventions and Reduce Alcohol Related Negative Outcomes at Community Level (PINO): Study Protocol for a Quasi-experimental 3-arm Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A quasi-experimental three-arm implementation study will be undertaken in Flanders (Belgium) to assess the effects of tailored training and support to general practitioners (GPs) alone or in an area context of alcohol community actions and compared to 'support as usual' on GP's performance in terms of early identification of hazardous and harmful drinking and brief intervention.
The study will last 18 months and will take place in three cities of comparable size. In each area at least 28 GPs will be recruited.
The primary outcome will be the proportion of consulting adult patients screened for hazardous and harmful alcohol use at the end-point of an 18-month implementation period. The secondary outcomes will be the screening rate as assessed at 3, 6, 9, 12 and 15 months and the proportion of patients screening positive for hazardous and harmful alcohol use that receive a brief intervention at 3,6,9, 12, 15 and 18 months. Furthermore, the relation between GP's views and needs and practices' contexts, and EIBI performance will be explored.
Data regarding screening and brief intervention activities will be collected from the electronic health records (EHR).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ann Li, master
- Phone Number: +32 16 37 21 82
- Email: ann.li@kuleuven.be
Study Contact Backup
- Name: Cathy Matheï, master
- Email: catharina.mathei@kuleuven.be
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- GP or GP trainee
- Dutch language use in practice
- Working in general practice in 3 cities of comparable size or their sub municipalities
Exclusion Criteria:
- No possibility of integration of e-form into the EHR-system.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Support as usual
There will be no interventions, only support as usual. All GPs receive an information package by post or via e-mail containing:
An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider. |
|
Active Comparator: Training and support
All GPs receive an information package by post or via e-mail containing:
An EHR-update allows the use of an extra e-form permitting standardised introduction of screening results from the Alcohol Use Disorders Identification Test (-Consumption) (AUDIT(-C)), alcohol-related diagnoses and actions including provision of oral brief advice/intervention, referral to a digital-based system for advice and/or referral to another health care provider. There shall be tailored training and support for the general practioners. At the start of the study, this group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months. |
GP's receive the tools to make early identification of harmful and hazardous alcohol use possible.
They are given guidelines to apply a brief intervention.
At the start of the study, the T&S-group receives two face-to-face educational trainings of two hours each.
Another two face-to-face booster sessions will follow at 6 and at 12 months.
|
Active Comparator: Training and support and community actions
In this group, GPs receive the same training and support as in the second arm (training and support).
There will also be embedded community-based actions within a local strategy.
|
GP's receive the tools to make early identification of harmful and hazardous alcohol use possible.
They are given guidelines to apply a brief intervention.
At the start of the study, the T&S-group receives two face-to-face educational trainings of two hours each.
Another two face-to-face booster sessions will follow at 6 and at 12 months.
There will be embedded community-based actions within a local strategy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Identification Rate (EIR)
Time Frame: 18 months
|
The Primary outcome or the Early Identification Rate (EIR) is the proportion of adult consulting patients (18 years and over) that is screened for alcohol consumption during a period of 18 months per area.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EIR every 3 months
Time Frame: at 3, 6, 9, 12 and 15 months
|
The Early Identification Rate (EIR) assessed at 3, 6, 9, 12 and 15 months per area.
|
at 3, 6, 9, 12 and 15 months
|
BIR
Time Frame: at 3, 6, 9, 12, 15 and 18 months
|
The Brief Intervention rate (BIR) is the proportion of patients screening positive for hazardous or harmful alcohol use that received oral brief advice/intervention and/or were referred to digital-based system for advice, and/or were referred to another provider assessed at 3, 6, 9, 12, 15 and 18 months per area.
|
at 3, 6, 9, 12, 15 and 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cathy Matheï, master, Professor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- s63342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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