| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN06145674 |
| Date ISRCTN assigned | 08/06/2007 |
| Local reference number(s) | SIPS-PHC |
| Public title | Pragmatic cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of primary health care screening and brief alcohol intervention |
| Scientific title |
|
| Acronym | SIPS (PHC) |
| Disease/condition/study domain | Hazardous alcohol consumption in primary care |
| Study hypothesis | The more intensive brief interventions for hazardous and harmful drinkers will be more effective, as follows: lifestyle counselling > simple structured advice > Patient information leaftlet. |
| Design/methodology | Pragmatic, cluster randomised controlled trial. |
| Research ethics review | London Local Research Ethic Committees (LREC), approved on 30/03/2007 (ref: 06/MRE02/90) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Positive screening result on Fast Alcohol Screen Test (FAST) or the Single Alcohol Screening Questionnaire (SASQ)
2. Patient who is alert and orientated
3. Aged 18 or over
4. Able to speak English sufficiently well to complete study questionnaires
5. Resident within England |
| Participants - exclusion criteria | 1. Patients already in contact with alcohol services
2. Those already included in the study
3. Those requesting tertiary level help with alcohol problems
4. Significant psychiatric disorder |
| Patient information material |
|
| Anticipated start date | 01/04/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Ongoing |
| Target number of participants | 744 |
| Interventions | 1. Control condition: Practices in the control condition will record the screening outcome, feedback the result of screening to patients and offer them a Patient Information Leaflet (PIL).
The PIL to be used in this trial ¿Alcohol and Sensible Drinking¿ is readily available to Primary Health Care (PHC) clinicians via the EMIS computer system and contains details of a Drinkline telephone number. We will ensure that practice not using EMIS have a comparable written PIL available.
2. Simple structured advice: Clinicians who may be GPs or primary care nurses will feed back the results of screening to patients and deliver up to 5 minutes of simple structured advice, using the Drink-Less brief intervention materials (level 1), and offer them a PIL identical to that in the control condition.
3. Brief lifestyle counselling: Clinicians who may be GPs or primary care nurses will feedback the results of screening to patients and deliver 15-20 minutes of lifestyle counselling using the Drink-Less brief intervention materials (level 2). |
| Primary outcome measure(s) | Alcohol Use Disorders Identification Test (AUDIT)-C at baseline and 6 months. |
| Secondary outcome measure(s) | The following will be assessed at baseline and 6 months:
1. EQ-5D questionnaire (quality of life assessment)
2. Service utilisation
3. Alcohol Problems Questionnaire
4. Staff attitudinal and organisational measure |
| Trial website | http://www.sips.sghms.ac.uk/ |
| Sources of funding | The project is funded by the Department of Health as part of an action under the government¿s Alcohol Harm Reduction Strategy for England (2004) (UK) |
| Sponsor name | St George's University of London (UK) |
| Sponsor details | Cranmer Terrace
London
United Kingdom
SW17 0RE |
| Sponsor telephone | +44 (0)20 82666426 |
| Sponsor email | pdeluca@sgul.ac.uk |
| Sponsor website | http://www.sgul.ac.uk/ |
| Contact name | Prof Colin Drummond |
| Contact details | Section of Addictive Behaviour
Division of Mental Health
St George's University of London
Cranmer Terrace
London
United Kingdom
SW17 0RE |
| Contact email | pdeluca@sgul.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN06145674 |
| Date last extracted from ISRCTN register | 17/04/2008 |
