Contact information
Type
Scientific
Primary contact
Dr Eileen Kaner
ORCID ID
Contact details
The Department of Primary Health Care
Centre for Health Service Research
21 Claremont Place
Framlington Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 7884
e.f.s.kaner@newcastle.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
rctc122 RES2301/7001
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Alcohol dependence
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Weekly alcohol consumption (units), assessed at 12 months after intervention.
Secondary outcome measures
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.
Overall trial start date
01/01/1999
Overall trial end date
31/12/2002
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
127
Participant exclusion criteria
1. Current major physical or psychiatric illness
2. Severe alcohol dependence
3. Severe brain damage or mental impairment
Recruitment start date
01/01/1999
Recruitment end date
31/12/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Department of Primary Health Care
Newcastle upon Tyne
NE2 4AA
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Northern and Yorkshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
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
Publication citations
-
Lock CA, Kaner EF, Implementation of brief alcohol interventions by nurses in primary care: do non-clinical factors influence practice?, Fam Pract, 2004, 21, 3, 270-275.
-
Lock CA, Kaner E, Heather N, Doughty J, Crawshaw A, McNamee P, Purdy S, Pearson P, Effectiveness of nurse-led brief alcohol intervention: a cluster randomized controlled trial., J Adv Nurs, 2006, 54, 4, 426-439, doi: 10.1111/j.1365-2648.2006.03836.x.