Screening and Intervention Programme for Sensible drinking - Primary Health Care
| ISRCTN | ISRCTN06145674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06145674 |
| Secondary identifying numbers | SIPS-PHC |
- Submission date
- 30/04/2007
- Registration date
- 08/06/2007
- Last edited
- 22/02/2013
- 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
Prof Colin Drummond
Scientific
Scientific
Section of Alcohol Research
National Addiction Centre, PO48
Division of Psychological Medicine and Psychiatry
Institute of Psychiatry, King's College London
4 Windsor Walk
London
SE5 8BB
United Kingdom
Study information
| Study design | Pragmatic cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pragmatic cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of primary health care screening and brief alcohol intervention |
| Study acronym | SIPS (PHC) |
| Study objectives | The more intensive brief interventions for hazardous and harmful drinkers will be more effective, as follows: lifestyle counselling is more effective than simple structured advice, which is in turn more effective than a patient information leaflet. As of 11/03/2009 this record was updated to include an extended anticipated end date; the initial end date at the time of registration was 31/12/2008. At this time, the sponsor field was also updated to include the current sponsor of Institute of Psychiatry, King's College London (UK). The initial sponsor at the time of registration was St George's University of London (UK). |
| Ethics approval(s) | London Local Research Ethics Committees (LREC) approved on the 30th March 2007 (ref: 06/MRE02/90) |
| Health condition(s) or problem(s) studied | Hazardous alcohol consumption in primary care |
| Intervention | 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). |
| Intervention type | Other |
| Primary outcome measure | Alcohol Use Disorders Identification Test (AUDIT) at baseline and 6 months. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/04/2007 |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 744 |
| Key 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, either sex 4. Able to speak English sufficiently well to complete study questionnaires 5. Resident within England |
| Key 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 |
| Date of first enrolment | 01/04/2007 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Section of Alcohol Research
London
SE5 8BB
United Kingdom
SE5 8BB
United Kingdom
Sponsor information
Institute of Psychiatry, Kings College London (UK)
University/education
University/education
4 Windsor Walk
London
SE5 8BB
England
United Kingdom
| paolo.deluca@iop.kcl.ac.uk | |
| Website | http://www.iop.kcl.ac.uk |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Department of Health (UK) - part of an action under the governments Alcohol Harm Reduction Strategy for England (2004)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 10/08/2009 | Yes | No | |
| Results article | results | 09/01/2013 | Yes | No |
