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ISRCTN
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ISRCTN15160309
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of the effectiveness and cost-effectiveness of nurse-led screening and brief alcohol interventions (SBI) in primary health care (PHC)
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Scientific title
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Acronym
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N/A
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Serial number at source
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rctc122 RES2301/7001
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Study hypothesis
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Pragmatic cluster randomised controlled trial aiming to evaluate the impact of nurse-led screening and brief alcohol intervention compared to current standard practice in primary care. Hypothesis was that brief intervention would be more effective at reducing risky alcohol consumption than routine advice.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Alcohol dependence
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Participants - inclusion criteria
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1. Patients (male and female) aged 16+ years
2. Attending primary care nurses (practice nurses, district nurses, health visitors, midwives and community psychiatric nurses [CPNs]) in practices from the former Yorkshire Regional Health Authority area
3. Men scoring 8+ and women scoring 7+ on the AUDIT screening questionnaire
4. Consent
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Participants - exclusion criteria
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1. Current major physical or psychiatric illness
2. Severe alcohol dependence
3. Severe brain damage or mental impairment
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Anticipated start date
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01/01/1999
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Anticipated end date
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31/12/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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127
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Interventions
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This is a pragmatic trial with cluster randomisation of practices. Nurses from the randomly selected practices will screen patients to identify excessive drinking and carry out baseline assessments with excessive drinkers who consent to the trial. Thereafter, SBI nurses provide brief intervention according to a structured protocol whilst controls provide advice as per standard treatment. Study outcome measures are assessed at 12 months after intervention. Longer term follow-up of patients is planned for 36 months after intervention but will be contingent on finding effects at 12 months.
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Primary outcome measure(s)
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Weekly alcohol consumption (units), assessed at 12 months after intervention.
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Secondary outcome measure(s)
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1. Drinking problems index, assessed at 12 months after intervention.
2. Screening score, assessed at 12 months after intervention.
3. Quality of life (12-item short form health survey [SF12]), assessed at 12 months after intervention.
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Sources of funding
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NHS Executive Northern and Yorkshire (UK)
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Trial website
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15128688
2. http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16671972
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Contact name
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Dr
Eileen
Kaner
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Address
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The Department of Primary Health Care
Centre for Health Service Research
21 Claremont Place
Framlington Place
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City/town
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Newcastle upon Tyne
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Zip/Postcode
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NE2 4AA
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Country
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United Kingdom
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Tel
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+44 (0)191 222 7884
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Email
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e.f.s.kaner@newcastle.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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20/12/2007
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Date ISRCTN assigned
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23/01/2004
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