Primary Care Implementation Study to Scale up EIBI and Reduce Alcohol Related Negative Outcomes

Study Overview
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Brief Summary
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The aim of this implementation study is to compare the effect of tailored training and support (T&S) for general practioners with T&S and alcohol community actions and the impact it has on early identification of hazardous and harmful drinking and brief intervention.

Detailed Description
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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).

Official Title
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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

Conditions
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Harmful; Use, Alcohol, Hazardous; Use, Alcohol

Intervention / Treatment
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* Behavioral: Training and support
* Behavioral: Community actions


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Support as usual<br>There will be no interventions, only support as usual. All GPs receive an information package by post or via e-mail containing: Belgian guidelines on the management of hazardous and harmful alcohol use A summary card about EIBI for hazardous and harmful alcohol consumption. Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31). 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<br>All GPs receive an information package by post or via e-mail containing: Belgian guidelines on the management of hazardous and harmful alcohol use A summary card about EIBI for hazardous and harmful alcohol consumption. Internet links to documentation of the medical association and the Flemish centre of expertise on alcohol and drugs(31). 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. | Behavioral: Training and support<br>* 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.<br>|
| Active Comparator: Training and support and community actions<br>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. | Behavioral: Training and support<br>* 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.<br>Behavioral: Community actions<br>* There will be embedded community-based actions within a local strategy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Identification Rate (EIR) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol, Screening, Brief Intervention, Implementation, Training and Support, Primary Healthcare, Scaling up, Community actions, hazardous alcohol use heavy drinking, harmful use of alcohol, heavy drinking