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

Harmful; Use, Alcohol Clinical Trial

— PINO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04398576
• Other study ID #: s63342
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: February 2022

Study information

• Verified date: May 2020
• Source: KU Leuven
• Contact: Ann Li, master
• Phone: +32 16 37 21 82
• Email: ann.li[@]kuleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: February 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Harmful; Use, Alcohol
• Hazardous; Use, Alcohol

Intervention

Behavioral:
• 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.
• Community actions
There will be embedded community-based actions within a local strategy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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