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

Alcoholism Clinical Trial

— ODHIN_RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501552
• Other study ID #: ECGA259268
• Status: Completed
• Phase: N/A
• First received: December 16, 2011
• Last updated: September 5, 2016
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2016
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Departament de Salut de la Generalitat de Catalunya
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcoholism

Intervention

Other:
• Training 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.
• Financial 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.
• E-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).

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht
Netherlands	Stichting Katholieke Universiteit	Nijmegen
Poland	Pomorski Uniwersytet Medyczny w Szczecinie	Szczecin
Poland	Panstwowa Agencja Rozwiazywania Problemow Alkoholowych	Warsaw
Spain	Departament de Salut de la Generalitat de Catalunya	Barcelona	Catalonia
Sweden	Goeteborgs Universitet	Goeteborg
Sweden	Linköping University	Linköping
United Kingdom	King's College London	London	England
United Kingdom	University College, London	London	England
United Kingdom	University of Newcastle Upon-Tyne	Newcastle Upon-Tyne	England

Sponsors (12)

Lead Sponsor	Collaborator
Fundacion Clinic per a la Recerca Biomédica	Department of Health, Generalitat de Catalunya, European Commission, Goeteborgs Universitet, King's College London, Linkoeping University, Maastricht University, Panstwowa Agencja Rozwiazywania Problemow Alkoholowych, Pomorski Uniwersytet Medyczny w Szczecinie, Stichting Katholieke Universiteit, University College, London, University of Newcastle Upon-Tyne

Countries where clinical trial is conducted

Netherlands,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care	Screening 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).	5 months	No
Primary	Number of brief interventions for excessive alcohol consumption delivered in primary health care settings	Brief 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).	5 months	No
Secondary	Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument	Role 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.	3 months	No
Secondary	Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument	Therapeutic 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.	3 months	No

External Links

•   Optimizing delivery of health interventions project's website.