Clinical trial NCT04398576: Primary Care Implementation Study to Scale up EIBI and Reduce Alcohol Related Negative Outcomes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Harmful; Use, Alcohol
Hazardous; Use, Alcohol
Keywords: 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
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Early Identification Rate (EIR)
timeFrame: 18 months
Secondary outcomes:
measure: EIR every 3 months
timeFrame: at 3, 6, 9, 12 and 15 months
measure: BIR
timeFrame: at 3, 6, 9, 12, 15 and 18 months
Other outcomes:
Locations:
Study officials:
affiliation: professor
name: Cathy Matheï, master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.