Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

  2. 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.

Additional files

Editorial Notes