Clinical trial NCT01501552: Trial Testing the Effect of Strategies on Performance of Brief Intervention Programmes for Harmful Alcohol Consumption
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
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Primary health care
Identification and Brief Intervention Programmes
Hazardous and harmful alcohol consumption
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: European Commission
name: Stichting Katholieke Universiteit
name: University of Newcastle Upon-Tyne
name: King's College London
name: Göteborg University
name: Linkoeping University
name: Department of Health, Generalitat de Catalunya
name: State Agency for Solving Alcohol Problems
name: University College, London
name: Maastricht University
name: Pomeranian Medical University Szczecin
First posted: 2011-12-29
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Number of screening tests carried out in primary health care settings to detect excessive alcohol consumption care
timeFrame: 5 months
measure: Number of brief interventions for excessive alcohol consumption delivered in primary health care settings
timeFrame: 5 months
Secondary outcomes:
measure: Level of role security of primary health care providers measured by their answers to the SAAPPQ instrument
timeFrame: 3 months
measure: Level of therapeutic commitment of primary health care providers measured by their answers to the SAAPPQ instrument
timeFrame: 3 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
city: Nijmegen
country: Netherlands
facility: Stichting Katholieke Universiteit
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny w Szczecinie
city: Warsaw
country: Poland
facility: Panstwowa Agencja Rozwiazywania Problemow Alkoholowych
city: Barcelona
country: Spain
facility: Departament de Salut de la Generalitat de Catalunya
state: Catalonia
city: Goeteborg
country: Sweden
facility: Goeteborgs Universitet
city: Linköping
country: Sweden
facility: Linköping University
city: London
country: United Kingdom
facility: King's College London
state: England
city: London
country: United Kingdom
facility: University College, London
state: England
city: Newcastle Upon-Tyne
country: United Kingdom
facility: University of Newcastle Upon-Tyne
state: England
Study officials:
affiliation: Linkoeping University
name: Preben - Bendtsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborg University
name: Fredrik - Spak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Peter - Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.