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

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ClinicalTrials.gov Identifier: NCT01501552
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : September 7, 2016
Sponsor:
Collaborators:
European Commission
Stichting Katholieke Universiteit
University of Newcastle Upon-Tyne
King's College London
Göteborg University
Linkoeping University
Department of Health, Generalitat de Catalunya
State Agency for Solving Alcohol Problems
University College, London
Maastricht University
Pomeranian Medical University Szczecin
Information provided by (Responsible Party):
Antoni Gual, Hospital Clinic of Barcelona

Tracking Information
First Submitted Date  ICMJE December 16, 2011
First Posted Date  ICMJE December 29, 2011
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care [ Time Frame: 5 months ]
    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 ]
    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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01501552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2011)
  • Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument [ Time Frame: 3 months ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • 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).
Study Arms  ICMJE
  • 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.
    Intervention: Other: Training and support (T&S)
  • 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.
    Intervention: Other: Financial incentive
  • 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).
    Intervention: Other: E-SBI (online screening and brief intervention)
  • 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.
    Interventions:
    • Other: Training and support (T&S)
    • Other: Financial incentive
  • 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).
    Interventions:
    • Other: Training and support (T&S)
    • Other: E-SBI (online screening and brief intervention)
  • 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.
    Interventions:
    • Other: Financial incentive
    • Other: E-SBI (online screening and brief intervention)
  • 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.
    Interventions:
    • Other: Training and support (T&S)
    • Other: Financial incentive
    • Other: E-SBI (online screening and brief intervention)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 27, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   Poland,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01501552
Other Study ID Numbers  ICMJE ECGA259268
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Antoni Gual, Hospital Clinic of Barcelona
Study Sponsor  ICMJE Fundacion Clinic per a la Recerca Biomédica
Collaborators  ICMJE
  • European Commission
  • Stichting Katholieke Universiteit
  • University of Newcastle Upon-Tyne
  • King's College London
  • Göteborg University
  • Linkoeping University
  • Department of Health, Generalitat de Catalunya
  • State Agency for Solving Alcohol Problems
  • University College, London
  • Maastricht University
  • Pomeranian Medical University Szczecin
Investigators  ICMJE
Principal Investigator: Preben - Bendtsen, MD Linkoeping University
Principal Investigator: Fredrik - Spak, MD Göteborg University
Principal Investigator: Peter - Anderson, MD Maastricht University
PRS Account Fundacion Clinic per a la Recerca Biomédica
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP