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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
European Commission
Stichting Katholieke Universiteit
University of Newcastle Upon-Tyne
King's College London
Goeteborgs Universitet
Linkoeping University
Departament de Salut de la Generalitat de Catalunya
Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
University College, London
Maastricht University
Pomorski Uniwersytet Medyczny w Szczecinie
Information provided by (Responsible Party):
Antoni Gual, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01501552
First received: December 16, 2011
Last updated: December 27, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Alcoholism
Other: Training and support (T&S)
Other: Financial incentive
Other: E-SBI (online screening and brief intervention)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
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

Resource links provided by NLM:


Further study details as provided by Fundacion Clinic per a la Recerca Biomédica:

Primary Outcome Measures:
  • Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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).

  • Number of brief interventions for excessive alcohol consumption delivered in primary health care settings [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as usual
In the no-intervention treatment as usual group, a package, containing a summary card of the national guideline recommendation, will be delivered to each provider unit without demonstration. In Poland, the summary card will be adapted from the PHEPA guidelines (ref) for the purposes of this trial. The treatment as usual group will be requested to screen and offer person-to-person SBI at the PHCU.
Experimental: Training & support (T&S)
The T&S only group will be offered 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.
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.
Experimental: Financial incentive
The financial incentive only group 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.
Other: 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.
Experimental: E-SBI
The e-SBI (online screening and brief intervention)only group are expected to refer 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).
Other: 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).
Experimental: T&S and financial incentive
The T&S and financial incentive group will be offered 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. Also, they 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.
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.
Other: 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.
Experimental: T&S and e-SBI
The T&S and e-SBI group will be offered 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 was offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) was offered. Also this group is expected to refer identified at-risk patients to an approved e-SBI (online screening and brief intervention) programme, which will either be country specific (where these exist) or based on the WHO e-SBI programme (Poland).
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.
Other: 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).
Experimental: Financial incentive and e-SBI
The financial incentive and e-SBI (online screening and brief intervention) group will be paid for screening and referral performance instead of actual delivery of e-SBI by themselves as in line with the e-SBI only group, 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.
Other: 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.
Other: 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).
Experimental: T&S, financial incentive and e-SBI
The T&S, financial incentive and e-SBI (online screening and brief intervention) group will be offered 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'). Also, they are expected to offer screening at the PHCU and to refer screen positive patients to e-SBI programmes. Additionally, they will be paid for screening and referral 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.
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.
Other: 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.
Other: 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).

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501552

Locations
Netherlands
Maastricht University
Maastricht, Netherlands, 229 ER
Stichting Katholieke Universiteit
Nijmegen, Netherlands, 6525 HP
Poland
Pomorski Uniwersytet Medyczny w Szczecinie
Szczecin, Poland, 70 204
Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
Warsaw, Poland, 01 458
Spain
Departament de Salut de la Generalitat de Catalunya
Barcelona, Catalonia, Spain, 08005
Sweden
Goeteborgs Universitet
Goeteborg, Sweden, PO Box 100, SE-405 30
Linköping University
Linköping, Sweden, SE-581 83
United Kingdom
King's College London
London, England, United Kingdom, SE1 8WA
University College, London
London, England, United Kingdom, WC1E 6HJ
University of Newcastle Upon-Tyne
Newcastle Upon-Tyne, England, United Kingdom, NE1 7RU
Sponsors and Collaborators
Fundacion Clinic per a la Recerca Biomédica
European Commission
Stichting Katholieke Universiteit
University of Newcastle Upon-Tyne
King's College London
Goeteborgs Universitet
Linkoeping University
Departament de Salut de la Generalitat de Catalunya
Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
University College, London
Maastricht University
Pomorski Uniwersytet Medyczny w Szczecinie
Investigators
Principal Investigator: Preben - Bendtsen, MD Linkoeping University
Principal Investigator: Fredrik - Spak, MD Goeteborgs Universitet
Principal Investigator: Peter - Anderson, MD Maastricht University
  More Information

Additional Information:
No publications provided by Fundacion Clinic per a la Recerca Biomédica

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antoni Gual, Head of the Alcohol Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01501552     History of Changes
Other Study ID Numbers: ECGA259268
Study First Received: December 16, 2011
Last Updated: December 27, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Departament de Salut de la Generalitat de Catalunya

Keywords provided by Fundacion Clinic per a la Recerca Biomédica:
Primary health care
Identification and Brief Intervention Programmes
Hazardous and harmful alcohol consumption

Additional relevant MeSH terms:
Alcohol Drinking
Alcoholism
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014