Condition category
Not Applicable
Date applied
17/10/2012
Date assigned
17/10/2012
Last edited
26/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The European level of alcohol consumption, and the subsequent burden of disease, is high compared to the rest of the world. While screening and brief interventions in primary health care are cost-effective, in most countries they have been rarely used in routine primary health care. This study aims to examine the effectiveness and efficiency of three implementation strategies which target key barriers for improvement: training and support to address lack of knowledge and motivation in healthcare providers, financial reimbursement to compensate the time investment, and referral to an internet-based programme to reduce workload. This study will collect data from Catalan, English, Netherlands, Polish and Swedish primary health care units on screening and brief advice rates for hazardous and harmful alcohol consumption.

Who can participate?
A total of 120 primary health care units will be included, equally distributed over the five countries. In England 24 GP practices will be enrolled; 12 in northeast England and 12 in London. Eligible GP practices will have about 5,000-20,000 registered patients. Within each GP practice, eligible health care providers will include any fully trained medical practitioner, nurse or practice assistant with a non-temporary employment contract working in eligible GP practices, and involved in direct medical and/or preventive care. Each health care provider individually will decide whether to sign up for the study.

What does the study involve?
The three implementation strategies will be provided separately and in combination in a total of seven intervention groups and compared with a control group who will provide treatment as usual. Each GP practice will be randomly allocated to one of the eight groups by the European coordinating centre. The health care providers will record their screening and brief advice activities at baseline (4 weeks), throughout the implementation period (12 weeks), and throughout the follow-up period (4 weeks).

What are the possible benefits and risks of participating?
Direct benefits to some GP practices will be in the form of training, payments and/or an internet support package. Patients may indirectly benefit due to an increase in screening and brief advice and support. There are no risks highlighted in taking part in the study.

Where is the study run from?
Goeteborgs Universitet and Linkopings Universtet, Catalonia

When is study starting and how long is it expected to run for?
January 2013 to April 2014

Who is funding the study?
Seventh Framework Programme, European Commission

Who is the main contact?
Dr Kathryn Parkinson
Kathryn.Parkinson@ncl.ac.uk

Trial website

http://odhinproject.eu/

Contact information

Type

Scientific

Primary contact

Dr Kathryn Parkinson

ORCID ID

Contact details

Newcastle University
4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
-
kathryn.parkinson@ncl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12870

Study information

Scientific title

Optimizing delivery of health care interventions (ODHIN)

Acronym

ODHIN

Study hypothesis

The ‘optimizing delivery of health care interventions’ study (ODHIN) is a Europe-wide project that will help to optimize the delivery of health care interventions by understanding how better to translate the results of clinical research into every day practice. ODHIN will use hazardous and harmful alcohol consumption in primary health care as a case study investigating the implementation of identification and brief intervention programme. This is an ideal health issue to investigate implementation of interventions because there is strong evidence for the effectiveness and cost-effectiveness of brief interventions in reducing hazardous and harmful alcohol consumption, but they are not routinely delivered by primary health care providers.

The aim of work package 5 is to study the improvement rates of alcohol screening and brief intervention activities in a cluster randomised controlled factorial trial with five arms (Catalonia; England; the Netherlands; Poland; Sweden) and three time phases (baseline; 12 week implementation period; 4 week follow-up period after 6 months has elapsed from end of implementation period). It will test the impact in primary health care (training and support; financial reimbursement; referral to an internet-based brief intervention package [e-BI]; the former strategies singly or in combination) on screening and brief intervention rates for Hazardous and harmful alcohol consumption compared with practice receiving treatment as usual (i.e. control group).

The English arm of the study will be conducted by Newcastle University in northeast England, and by King'’s College London in London. The unit of randomisation will be GP practices, and the participants will be the health care providers working within the GP practices. The two primary outcome measures will be screening and brief advice rates for patients. The results will add to the knowledge of how best to integrate evidence-based health intervention into primary health settings.

Ethics approval

NRES Committee: South West - Central Bristol, 13/09/2012 ref: 12/SC/0439

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format. The primary health care providers’ letter and information sheet can be requested from: Dr Kathryn Parkinson (Kathryn.Parkinson@ncl.ac.uk) or by telephone on +44 191 222 7400.

Condition

Primary Care Research Network for England: all Diseases

Intervention

GP practices will be randomised to one of 8 groups. All participating health professionals within each practice will be in the same group. Each will be given either training and support; financial reimbursement; referral to an internet-based brief intervention package [e-BI]; or a combination of the former strategies or none (i.e., control group).
Follow Up Length: 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Screening rates and brief advice rates mesaured at baseline and followed up after 4 weeks, 8 weeks, 12 weeks.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. GP practices will have an approximate size of 5,000-20,000 registered or listed patients. Eligible health care providers will include any fully trained medical practitioner, nurse or practice assistant with a non-temporary employment contract, working in the GP practice and involved in medical and/or preventive care.
2. Male and female participants
3. Aged 18 years and above

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 24

Participant exclusion criteria

If practice is already participating in an alcohol-related research study

Recruitment start date

01/11/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle University (UK)

Sponsor details

Institute of Human Genetics
International Centre For Life
Central Parkway
Newcastle Upon Tyne
NE1 3BZ
United Kingdom

Sponsor type

University/education

Website

http://www.ncl.ac.uk/

Funders

Funder type

Government

Funder name

Seventh Framework Programme

Alternative name(s)

EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Belgium

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23347874
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27237081

Publication citations

Additional files

Editorial Notes

26/08/2016: Publication references added.