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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04398576
Acronym
PINO
Enrollment
84
Registered
2020-05-21
Start date
2020-07-01
Completion date
2022-02-28
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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).

Interventions

BEHAVIORALCommunity actions

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

BEHAVIORALTraining 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.

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Early Identification Rate (EIR)18 monthsThe 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.

Secondary

MeasureTime frameDescription
BIRat 3, 6, 9, 12, 15 and 18 monthsThe 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.
EIR every 3 monthsat 3, 6, 9, 12 and 15 monthsThe Early Identification Rate (EIR) assessed at 3, 6, 9, 12 and 15 months per area.

Contacts

Primary ContactAnn Li, master
ann.li@kuleuven.be+32 16 37 21 82
Backup ContactCathy Matheï, master
catharina.mathei@kuleuven.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026