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 |
| Protocol serial number | rctc122 RES2301/7001 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- 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
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 |
|---|---|
| e.f.s.kaner@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Weekly alcohol consumption (units), assessed at 12 months after intervention. |
| Key secondary outcome measure(s) |
1. Drinking problems index, assessed at 12 months after intervention. |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
The Department of Primary Health Care
Newcastle upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
