NCT04398576

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

May 13, 2020

Last Update Submit

May 19, 2020

Conditions

Keywords

AlcoholScreeningBrief InterventionImplementationTraining and SupportPrimary HealthcareScaling upCommunity actionshazardous alcohol use heavy drinkingharmful use of alcoholheavy drinking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • EIR every 3 months

    at 3, 6, 9, 12 and 15 months

  • BIR

    at 3, 6, 9, 12, 15 and 18 months

Study Arms (3)

Support as usual

NO INTERVENTION

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.

Training and support

ACTIVE COMPARATOR

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

Training and support and community actions

ACTIVE COMPARATOR

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 supportBehavioral: Community actions

Interventions

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 supportTraining and support and community actions

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

Training and support and community actions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GP or GP trainee
  • Dutch language use in practice
  • Working in general practice in 3 cities of comparable size or their sub municipalities

You may not qualify if:

  • \- No possibility of integration of e-form into the EHR-system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Training SupportCommunity Participation

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and OrganizationsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesConsumer OrganizationsOrganizations

Study Officials

  • Cathy Matheï, master

    professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathy Matheï, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 21, 2020

Study Start

July 1, 2020

Primary Completion

October 1, 2021

Study Completion

February 1, 2022

Last Updated

May 21, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share