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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)
ISRCTN ISRCTN15160309
DOI 10.1186/ISRCTN15160309
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised controlled trial of the effectiveness and cost-effectiveness of nurse-led screening and brief alcohol interventions (SBI) in primary health care (PHC)
Scientific title
Acronym N/A
Serial number at source rctc122 RES2301/7001
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Alcohol dependence
Participants - inclusion criteria 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
Participants - exclusion criteria 1. Current major physical or psychiatric illness
2. Severe alcohol dependence
3. Severe brain damage or mental impairment
Anticipated start date 01/01/1999
Anticipated end date 31/12/2002
Status of trial Completed
Patient information material
Target number of participants 127
Interventions 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.
Primary outcome measure(s) Weekly alcohol consumption (units), assessed at 12 months after intervention.
Secondary outcome measure(s) 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.
Sources of funding NHS Executive Northern and Yorkshire (UK)
Trial website
Publications 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
Contact name Dr  Eileen  Kaner
  Address The Department of Primary Health Care
Centre for Health Service Research
21 Claremont Place
Framlington Place
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4AA
  Country United Kingdom
  Tel +44 (0)191 222 7884
  Email e.f.s.kaner@newcastle.ac.uk
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0) 20 7307 2622
  Fax +44 (0) 20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 20/12/2007
Date ISRCTN assigned 23/01/2004
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