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

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Training and support (T&S)
Financial incentive
E-SBI (online screening and brief intervention)
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcoholism focused on measuring Primary health care, Identification and Brief Intervention Programmes, Hazardous and harmful alcohol consumption

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maastricht University
  • Stichting Katholieke Universiteit
  • Pomorski Uniwersytet Medyczny w Szczecinie
  • Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
  • Departament de Salut de la Generalitat de Catalunya
  • Goeteborgs Universitet
  • Linköping University
  • King's College London
  • University College, London
  • University of Newcastle Upon-Tyne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Treatment as usual

Training & support (T&S)

Financial incentive

E-SBI

T&S and financial incentive

T&S and e-SBI

Financial incentive and e-SBI

T&S, financial incentive and e-SBI

Arm Description

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.

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.

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.

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).

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.

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).

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.

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 16, 2011
Last Updated
September 5, 2016
Sponsor
Fundacion Clinic per a la Recerca Biomédica
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
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1. Study Identification

Unique Protocol Identification Number
NCT01501552
Brief Title
Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Clinic per a la Recerca Biomédica
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Primary health care, Identification and Brief Intervention Programmes, Hazardous and harmful alcohol consumption

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Training & support (T&S)
Arm Type
Experimental
Arm Description
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.
Arm Title
Financial incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
E-SBI
Arm Type
Experimental
Arm Description
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).
Arm Title
T&S and financial incentive
Arm Type
Experimental
Arm Description
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.
Arm Title
T&S and e-SBI
Arm Type
Experimental
Arm Description
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).
Arm Title
Financial incentive and e-SBI
Arm Type
Experimental
Arm Description
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.
Arm Title
T&S, financial incentive and e-SBI
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training and support (T&S)
Intervention Description
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 Type
Other
Intervention Name(s)
Financial incentive
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
E-SBI (online screening and brief intervention)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care
Description
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).
Time Frame
5 months
Title
Number of brief interventions for excessive alcohol consumption delivered in primary health care settings
Description
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).
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument
Description
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.
Time Frame
3 months
Title
Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preben - Bendtsen, MD
Organizational Affiliation
Linkoeping University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fredrik - Spak, MD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter - Anderson, MD
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
ZIP/Postal Code
229 ER
Country
Netherlands
Facility Name
Stichting Katholieke Universiteit
City
Nijmegen
ZIP/Postal Code
6525 HP
Country
Netherlands
Facility Name
Pomorski Uniwersytet Medyczny w Szczecinie
City
Szczecin
ZIP/Postal Code
70 204
Country
Poland
Facility Name
Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
City
Warsaw
ZIP/Postal Code
01 458
Country
Poland
Facility Name
Departament de Salut de la Generalitat de Catalunya
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08005
Country
Spain
Facility Name
Goeteborgs Universitet
City
Goeteborg
ZIP/Postal Code
PO Box 100, SE-405 30
Country
Sweden
Facility Name
Linköping University
City
Linköping
ZIP/Postal Code
SE-581 83
Country
Sweden
Facility Name
King's College London
City
London
State/Province
England
ZIP/Postal Code
SE1 8WA
Country
United Kingdom
Facility Name
University College, London
City
London
State/Province
England
ZIP/Postal Code
WC1E 6HJ
Country
United Kingdom
Facility Name
University of Newcastle Upon-Tyne
City
Newcastle Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 7RU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30239676
Citation
Angus C, Li J, Romero-Rodriguez E, Anderson P, Parrott S, Brennan A. Cost-effectiveness of strategies to improve delivery of brief interventions for heavy drinking in primary care: results from the ODHIN trial. Eur J Public Health. 2019 Apr 1;29(2):219-225. doi: 10.1093/eurpub/cky181.
Results Reference
derived
PubMed Identifier
29022763
Citation
Anderson P, Kloda K, Kaner E, Reynolds J, Bendtsen P, Pelgrum-Keurhorst MN, Segura L, Wojnar M, Mierzecki A, Deluca P, Newbury-Birch D, Parkinson K, Okulicz-Kozaryn K, Drummond C, Laurant MGH, Gual A. Impact of practice, provider and patient characteristics on delivering screening and brief advice for heavy drinking in primary healthcare: Secondary analyses of data from the ODHIN five-country cluster randomized factorial trial. Eur J Gen Pract. 2017 Dec;23(1):241-245. doi: 10.1080/13814788.2017.1374365.
Results Reference
derived
PubMed Identifier
28694269
Citation
Anderson P, Coulton S, Kaner E, Bendtsen P, Kloda K, Reynolds J, Segura L, Wojnar M, Mierzecki A, Deluca P, Newbury-Birch D, Parkinson K, Okulicz-Kozaryn K, Drummond C, Gual A. Delivery of Brief Interventions for Heavy Drinking in Primary Care: Outcomes of the ODHIN 5-Country Cluster Randomized Trial. Ann Fam Med. 2017 Jul;15(4):335-340. doi: 10.1370/afm.2051.
Results Reference
derived
PubMed Identifier
27422283
Citation
Keurhorst M, Anderson P, Heinen M, Bendtsen P, Baena B, Brzozka K, Colom J, Deluca P, Drummond C, Kaner E, Kloda K, Mierzecki A, Newbury-Birch D, Okulicz-Kozaryn K, Palacio-Vieira J, Parkinson K, Reynolds J, Ronda G, Segura L, Slodownik L, Spak F, van Steenkiste B, Wallace P, Wolstenholme A, Wojnar M, Gual A, Laurant M, Wensing M. Impact of primary healthcare providers' initial role security and therapeutic commitment on implementing brief interventions in managing risky alcohol consumption: a cluster randomised factorial trial. Implement Sci. 2016 Jul 16;11:96. doi: 10.1186/s13012-016-0468-5.
Results Reference
derived
PubMed Identifier
27311902
Citation
Bendtsen P, Mussener U, Karlsson N, Lopez-Pelayo H, Palacio-Vieira J, Colom J, Gual A, Reynolds J, Wallace P, Segura L, Anderson P. Implementing referral to an electronic alcohol brief advice website in primary healthcare: results from the ODHIN implementation trial. BMJ Open. 2016 Jun 16;6(6):e010271. doi: 10.1136/bmjopen-2015-010271.
Results Reference
derived
PubMed Identifier
27267887
Citation
Keurhorst M, Heinen M, Colom J, Linderoth C, Mussener U, Okulicz-Kozaryn K, Palacio-Vieira J, Segura L, Silfversparre F, Slodownik L, Sorribes E, Laurant M, Wensing M. Strategies in primary healthcare to implement early identification of risky alcohol consumption: why do they work or not? A qualitative evaluation of the ODHIN study. BMC Fam Pract. 2016 Jun 7;17:70. doi: 10.1186/s12875-016-0461-8.
Results Reference
derived
PubMed Identifier
27237081
Citation
Anderson P, Bendtsen P, Spak F, Reynolds J, Drummond C, Segura L, Keurhorst MN, Palacio-Vieira J, Wojnar M, Parkinson K, Colom J, Kloda K, Deluca P, Baena B, Newbury-Birch D, Wallace P, Heinen M, Wolstenholme A, van Steenkiste B, Mierzecki A, Okulicz-Kozaryn K, Ronda G, Kaner E, Laurant MG, Coulton S, Gual T. Improving the delivery of brief interventions for heavy drinking in primary health care: outcome results of the Optimizing Delivery of Health Care Intervention (ODHIN) five-country cluster randomized factorial trial. Addiction. 2016 Nov;111(11):1935-1945. doi: 10.1111/add.13476. Epub 2016 Jul 25.
Results Reference
derived
PubMed Identifier
23347874
Citation
Keurhorst MN, Anderson P, Spak F, Bendtsen P, Segura L, Colom J, Reynolds J, Drummond C, Deluca P, van Steenkiste B, Mierzecki A, Kloda K, Wallace P, Newbury-Birch D, Kaner E, Gual T, Laurant MG. Implementing training and support, financial reimbursement, and referral to an internet-based brief advice program to improve the early identification of hazardous and harmful alcohol consumption in primary care (ODHIN): study protocol for a cluster randomized factorial trial. Implement Sci. 2013 Jan 24;8:11. doi: 10.1186/1748-5908-8-11.
Results Reference
derived
Links:
URL
http://www.odhinproject.eu
Description
Optimizing delivery of health interventions project's website.

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

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