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

NCT ID: NCT04398576

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-02-28

Brief Summary

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

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).

Conditions

Harmful; Use, Alcohol; Hazardous; Use, Alcohol

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Training and support

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Training and support

Intervention Type: BEHAVIORAL

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.

Community actions

Intervention Type: BEHAVIORAL

There will be embedded community-based actions within a local strategy.

Interventions

Training and support

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.

Intervention Type: BEHAVIORAL

Community actions

There will be embedded community-based actions within a local strategy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Cathy Matheï

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cathy Matheï, master

Role: PRINCIPAL_INVESTIGATOR

professor

Central Contacts

Ann Li, master

Role: CONTACT

ann.li@kuleuven.be

+32 16 37 21 82

Cathy Matheï, master

Role: CONTACT

catharina.mathei@kuleuven.be

References

Pussig B, Pas L, Li A, Vermandere M, Aertgeerts B, Mathei C. Primary care implementation study to scale up early identification and brief intervention and reduce alcohol-related negative outcomes at the community level (PINO): study protocol for a quasi-experimental 3-arm study. BMC Fam Pract. 2021 Jul 1;22(1):144. doi: 10.1186/s12875-021-01479-9.

Reference Type: DERIVED

PMID: 34210261 (View on PubMed)

Other Identifiers

s63342

Identifier Type: -

Identifier Source: org_study_id