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	https://doi.org/10.1186/ISRCTN15160309
Secondary identifying numbers	rctc122 RES2301/7001

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 01/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eileen Kaner
Scientific

The Department of Primary Health Care
Centre for Health Service Research
21 Claremont Place
Framlington Place
Newcastle upon Tyne
NE2 4AA
United Kingdom

Phone	+44 (0)191 222 7884
Email	e.f.s.kaner@newcastle.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific 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)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/1999
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	127
Total final enrolment	127
Key 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
Key exclusion criteria	1. Current major physical or psychiatric illness 2. Severe alcohol dependence 3. Severe brain damage or mental impairment
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

The Department of Primary Health Care

Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Northern and Yorkshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/06/2004		Yes	No
Results article		01/05/2006		Yes	No

Editorial Notes

01/11/2022: Total final enrolment added.