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

NCT01501552 | Completed

• 1 other identifier: ECGA259268
• Study Type: interventional
• Target: 120
• Locations: 5 countries
• Sites: 10

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.

Conditions

Alcoholism

Keywords

Primary health care; Identification and Brief Intervention Programmes; Hazardous and harmful alcohol consumption

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument

  3 months

• Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument

  3 months

Study Arms (8)

Treatment as usual

NO INTERVENTION

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.

Training & support (T&S)

EXPERIMENTAL

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)

Financial incentive

EXPERIMENTAL

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

E-SBI

EXPERIMENTAL

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)

T&S and financial incentive

EXPERIMENTAL

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); Other: Financial incentive

T&S and e-SBI

EXPERIMENTAL

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); Other: E-SBI (online screening and brief intervention)

Financial incentive and e-SBI

EXPERIMENTAL

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; Other: E-SBI (online screening and brief intervention)

T&S, financial incentive and e-SBI

EXPERIMENTAL

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); Other: Financial incentive; Other: E-SBI (online screening and brief intervention)

Interventions

Training and support (T&S) OTHER

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.

T&S and e-SBI; T&S and financial incentive; T&S, financial incentive and e-SBI; Training & support (T&S)

Financial incentive OTHER

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.

Financial incentive; Financial incentive and e-SBI; T&S and financial incentive; T&S, financial incentive and e-SBI

E-SBI (online screening and brief intervention) OTHER

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).

E-SBI; Financial incentive and e-SBI; T&S and e-SBI; T&S, financial incentive and e-SBI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Primary Health Care Units with less than 5.000 registered patients or over 20.000 registered patients

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead
• European Commission: collaborator
• Stichting Katholieke Universiteit: collaborator
• University of Newcastle Upon-Tyne: collaborator
• King's College London: collaborator
• Göteborg University: collaborator
• Linkoeping University: collaborator
• Department of Health, Generalitat de Catalunya: collaborator
• State Agency for Solving Alcohol Problems: collaborator
• University College, London: collaborator
• Maastricht University: collaborator
• Pomeranian Medical University Szczecin: collaborator

Study Sites (10)

Maastricht University

Maastricht, Netherlands, 229 ER, Netherlands

Location

Stichting Katholieke Universiteit

Nijmegen, Netherlands, 6525 HP, Netherlands

Location

Pomorski Uniwersytet Medyczny w Szczecinie

Szczecin, Poland, 70 204, Poland

Location

Panstwowa Agencja Rozwiazywania Problemow Alkoholowych

Warsaw, Poland, 01 458, Poland

Location

Departament de Salut de la Generalitat de Catalunya

Barcelona, Catalonia, 08005, Spain

Location

Goeteborgs Universitet

Gothenburg, Sweden, PO Box 100, SE-405 30, Sweden

Location

Linköping University

Linköping, Sweden, SE-581 83, Sweden

Location

King's College London

London, England, SE1 8WA, United Kingdom

Location

University College, London

London, England, WC1E 6HJ, United Kingdom

Location

University of Newcastle Upon-Tyne

Newcastle upon Tyne, England, NE1 7RU, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 30239676 DERIVED

• 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.

  PMID: 29022763 DERIVED

• 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.

  PMID: 28694269 DERIVED

• 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.

  PMID: 27422283 DERIVED

• 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.

  PMID: 27311902 DERIVED

• 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.

  PMID: 27267887 DERIVED

• 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.

  PMID: 27237081 DERIVED

• 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.

  PMID: 23347874 DERIVED

Related Links

• Optimizing delivery of health interventions project's website.

MeSH Terms

Conditions

Alcoholism

Interventions

Palliative Care; Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Preben - Bendtsen, MD

  Linkoeping University

  PRINCIPAL INVESTIGATOR

• Fredrik - Spak, MD

  Göteborg University

  PRINCIPAL INVESTIGATOR

• Peter - Anderson, MD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Alcohol Unit

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 29, 2011
• Study Start: January 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

NL (2); PL (2); GB (3); ES (1); SE (2)