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Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption

Randomised Controlled Trial Testing the Incremental Effect of Strategies That Raise Awareness, Acceptance and Performance of Identification and Brief Intervention Programmes for Harmful Alcohol Consumption in Primary Health Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01501552
Acronym
ODHIN_RCT
Enrollment
120
Registered
2011-12-29
Start date
2012-01-31
Completion date
2014-12-31
Last updated
2016-09-07

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

Conditions

Alcoholism

Keywords

Primary health care, Identification and Brief Intervention Programmes, Hazardous and harmful alcohol consumption

Brief summary

The overall objective is to study if training and support, financial reimbursement and referral to an internet based brief intervention programme, singly or in combination, may increase implementation of evidence based methods of identification and brief intervention for excessive alcohol consumption in routine primary health care.

Detailed description

The study will be a stepped cluster RCT in 5 countries and the endpoint of the study is the number of interventions delivered during a certain time period. More specifically, the RCT will examine: * The effect of Continuous Medical Education (CME) to PHC providers * The effect of financial reimbursement to PHC providers as a pay-for-performance of brief alcohol interventions * Whether an alternative internet based method of delivering brief intervention can increase the proportion of patients reached * If one implementation strategy will give an added value to one already enforced.

Interventions

OTHERTraining and support (T&S)

Two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) may be offered. The time interval between meetings will be on average 2 weeks. The training sessions will address improving knowledge, skills, attitudes, and perceived barriers and facilitators by combining theory and practice-based training.

OTHERFinancial incentive

Groups will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.

OTHERE-SBI (online screening and brief intervention)

Referring identified at-risk patients to an approved e-SBI programme, which will be either country specific (where these exist) or based on the WHO e-SBI programme (Poland).

Sponsors

European Commission
CollaboratorOTHER
Stichting Katholieke Universiteit
CollaboratorOTHER
University of Newcastle Upon-Tyne
CollaboratorOTHER
King's College London
CollaboratorOTHER
Göteborg University
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV
Department of Health, Generalitat de Catalunya
CollaboratorOTHER_GOV
State Agency for Solving Alcohol Problems
CollaboratorOTHER
University College, London
CollaboratorOTHER
Maastricht University
CollaboratorOTHER
Pomeranian Medical University Szczecin
CollaboratorOTHER
Fundacion Clinic per a la Recerca Biomédica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Primary Health Care Units (PHCU) of approximate size of 5.000-20.000 registered patients * Primary Health Care Units (PHCU) located in Spain, Poland, Sweden, England or The Netherlands * Providers must be physicians or nurses

Exclusion criteria

* Primary Health Care Units with less than 5.000 registered patients or over 20.000 registered patients

Design outcomes

Primary

MeasureTime frameDescription
Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care5 monthsScreening rates will be calculated at five time points: during a four week period during the third month before the start of the study (baseline measurement), in three consecutive four week blocks during the twelve week intervention period (intervention measurement) and during a four week block during the sixth month after the end of the intervention period (follow-up measurement).
Number of brief interventions for excessive alcohol consumption delivered in primary health care settings5 monthsBrief intervention rates will be calculated at five time points: during a four week period during the third month before the start of the study (baseline measurement), in three consecutive four week blocks during the twelve week intervention period (intervention measurement) and during a four week block during the sixth month after the end of the intervention period (follow-up measurement).

Secondary

MeasureTime frameDescription
Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument3 monthsRole security of the primary health care providers will be measured through their responses to the SAAPPQ (a validated instrument based on factor analysis (Anderson & Clement 1987) of the original alcohol and alcohol problems perception questionnaire developed and validated by Cartwright (1980))at three time points: baseline, end of intervention period, and follow-up.
Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument3 monthsTherapeutic commitment of the primary health care providers will be measured through their responses to the SAAPPQ (a validated instrument based on factor analysis (Anderson & Clement 1987) of the original alcohol and alcohol problems perception questionnaire developed and validated by Cartwright (1980))at three time points: baseline, end of intervention period, and follow-up.

Countries

Netherlands, Poland, Spain, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026