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

September 5, 2016 updated by: Antoni Gual, Fundacion Clinic per a la Recerca Biomédica

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 229 ER
        • Maastricht University
      • Nijmegen, Netherlands, 6525 HP
        • Stichting Katholieke Universiteit
  • Poland
      • Szczecin, Poland, 70 204
        • Pomorski Uniwersytet Medyczny w Szczecinie
      • Warsaw, Poland, 01 458
        • Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08005
        • Departament de Salut de la Generalitat de Catalunya
  • Sweden
      • Goeteborg, Sweden, PO Box 100, SE-405 30
        • Goeteborgs Universitet
      • Linköping, Sweden, SE-581 83
        • Linköping University
  • United Kingdom
    • England
      • London, England, United Kingdom, SE1 8WA
        • King's College London
      • London, England, United Kingdom, WC1E 6HJ
        • University College, London
      • Newcastle Upon-Tyne, England, United Kingdom, NE1 7RU
        • University of Newcastle Upon-Tyne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
5 months
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).
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion Clinic per a la Recerca Biomédica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King's College London
Göteborg University
University College, London
Linkoeping University
Pomeranian Medical University Szczecin
Maastricht University
European Commission
University of Newcastle Upon-Tyne
Stichting Katholieke Universiteit
Department of Health, Generalitat de Catalunya
State Agency for Solving Alcohol Problems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Preben - Bendtsen, MD, Linkoeping University
  • Principal Investigator: Fredrik - Spak, MD, Göteborg University
  • Principal Investigator: Peter - Anderson, MD, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECGA259268

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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