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

May 19, 2020 updated by: Cathy Matheï, KU Leuven

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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:

  • 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

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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Cathy Matheï, master, Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

May 21, 2020

Last Update Submitted That Met QC Criteria

May 19, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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