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

Abstract

Background

Primary healthcare-based Early Identification and Brief Intervention (EIBI) for hazardous and harmful alcohol use is both a clinically relevant and cost-effective strategy to reduce heavy drinking. Unfortunately, it remains poorly implemented in daily practice. Multiple studies have shown that training and support (T&S) programs can increase the use of EIBI. Nonetheless, gains have only been modest and short-term at best. Suggestions have been made to rely more on multicomponent programs that simultaneously address several barriers to the implementation of EIBI. The PINO-project aims to evaluate the added value of such a multicomponent program to improve EIBI delivery in daily practice.

Methods/design

A quasi-experimental three-arm implementation study in Flanders (Belgium) will assess the effects of tailored T&S to General Practitioners (GPs) with or without community mobilisation on EIBI delivery in general practice. The study lasts 18 months and will take place in three comparable municipalities. In municipality 1 and 2, GPs receive a tailored T&S program. The T&S is theoretically founded and tailored to the GPs’ views, needs and practice characteristics. Furthermore, community actions will be embedded within municipality 1 providing additional, contextual, support. In municipality 3, GPs are offered a minimal intervention to facilitate data collection.

The primary outcome is the proportion of adult patients screened for hazardous and harmful alcohol use at the end of an 18-month implementation period. The secondary outcome is the scaling up activity at municipal level in screening rates, as assessed every 3 months, and the proportion of patients who received an additional brief intervention when necessary. Furthermore, the correlation between the opinions and needs of the GP’s, their practice organisation and their EIBI performance will be explored.

Discussion

The PINO-project addresses the gap between what is theoretically possible and the current practice. This is an innovative study combining T&S at GP level with community actions. At the same time, it implements and evaluates practice T&S based on the theoretical domains framework.

Trial registration

This trial was approved by the Ethics Committee for Research of UZ/KU Leuven (reference number s63342 and G-2020-2177-R2(MAR)) and is registered on clinicaltrials.gov (NCT04398576) in May 2020.