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| The effectiveness and cost effectiveness of screening and stepped-care intervention for alcohol use disorders in the primary care setting |
| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN55274820 |
| Date ISRCTN assigned | 04/12/2006 |
| Local reference number(s) | N/A |
| Public title | The effectiveness and cost effectiveness of screening and stepped-care intervention for alcohol use disorders in the primary care setting |
| Scientific title | |
| Acronym | STEPWICE |
| Disease/condition/study domain | Alcohol Use Disorders |
| Study hypothesis | 1. Screening and stepped care interventions for alcohol use disorder are as effective as minimal interventions in primary care. 2. Screening and stepped care interventions for alcohol use disorder are as cost-effective as minimal interventions in primary care. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Iechyd Morgannwg Health Local Research Ethics Committee approval gained on 5th July 2000. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male 2. Age 18 to 65 (the reason for limiting the age range is that patients above and below this range are catered for by different services in Step 3) 3. Alcohol Use Disorders Identification Test (AUDIT) score more than or equal to eight 4. Diagnosis of an Alcohol Use Disorder according to the Internation Classification of Diseases (ICD-10) (hazardous or harmful drinking, alcohol dependence) as assessed by the baseline research interview 5. Consent to participate in either treatment, and follow-up 6. Willing to nominate an independent informant who the research team can contact to obtain information at baseline and during follow-up, and to nominate a ¿locator¿ who will be able to assist in tracing the subject at follow-up (the independent informant and locator may be the same person) 7. Stable place of residence 8. Living within commuting distance of the practice 9. No treatment for substance misuse in previous 30 days |
| Participants - exclusion criteria | 1. Current severe mental illness 2. Primary drug dependence (except nicotine and cannabis) 3. Severe physical illness that would preclude participation 4. Current legal problems likely to interfere with follow-up 5. Severe brain damage or mental impairment |
| Patient information material | |
| Anticipated start date | 01/06/2000 |
| Anticipated end date | 31/05/2003 |
| Status of trial | Completed |
| Target number of participants | 236 |
| Interventions | Stepped Care Intervention (SCI): This consists of three care steps: a. All SCI subjects receive one 40-minute session of Brief Motivational Intervention (BMI) in the general practice setting conducted by a trained Practice Nurse (PN). This intervention will be manual-guided using the method of Rollnick et al. All SCI subjects will then be followed-up by the PN with a phone call at two weeks, and face-to-face interview at one month post intervention in the primary care setting to assess response to the intervention. Subjects ¿not improved¿ will be referred to Step b. b. Manual-guided, outpatient Motivational Enhancement Therapy (MET) (four one hour sessions over two weeks) adapted from the Medical Research Council (MRC) funded UK Alcohol Treatment Trial intervention protocol (similar to the MET intervention used in Project MATCH), conducted by a trained Addiction Prevention Practitioner (APP) attached to the collaborating practices. The APP model has been described by Ghodse et al. This will be followed by a further phone call at two weeks and a follow-up face-to-face interview at one month post-MET by the PN to assess response to intervention. c. Subjects ¿not improved¿ will be referred to a specialist Community Alcohol Team (CAT) to receive specialist treatment (including, as necessary, inpatient care, outpatient counselling, group therapy, relapse prevention treatment, medication) with no limit on duration or intensity of Intervention. Control intervention: Minimal intervention will consist of one five minute session of advice to cut down drinking conducted by the trained PN and provision of an information leaflet on services available locally for problem drinkers, and a self-help booklet. The minimal intervention will also be manual guided. |
| Primary outcome measure(s) | Alcohol consumption obtained using the Time Line Follow-Back interview method (TLFB). This method will be used to provide two measures identical to the primary outcome measures used in project MATCH (Project MATCH Research Group, 1997), namely: 1. Mean number of Drinks per Drinking Day (DDD) 2. Percentage of Days Abstinent (PDA) |
| Secondary outcome measure(s) | 1. Alcohol-related problems: Alcohol Problems Questionnaire (APQ) 2. Blood investigations (Gamma-GlutamylTransferase [GGT], Carbohydrate-Deficient Transferrin [CDT-Axis], Mean Corpuscular Volume [MCV]) 3. Health related Quality of Life (Euroqol questionnaire [EQ-5D], Short Form health surveys [SF-36, SF-12]) 4. Health economic measures 5. Patient compliance (using attendance records) 6. Patient and clinician satisfaction using scales developed by the Kings College Group. Alcohol consumption and secondary measures 1, 2, & 3 will be included in the baseline assessment to: a. test the adequacy of matching between groups, and b. to act as covariates in subsequent analyses to control for baseline values. The Severity of Alcohol Dependence Questionnaire (SADQ), the Situational Confidence Questionnaire (SCQ) and the short Readiness to Change Questionnaire will also be administered at baseline and later investigated as predictors of outcome and care step utilisation. |
| Sources of funding | Wales Office of Research and Development (UK) |
| Sponsor name | Wales Office of Research and Development (UK) |
| Sponsor details | National Assembly for Wales Cardiff Bay Cardiff United Kingdom CF99 1NA |
| Sponsor telephone | +44 (0)29 2082 5111 |
| Sponsor email | WORD.Wales@gsi.gov.uk |
| Sponsor website | http://www.word.wales.gov.uk/ |
| Contact name | Prof Colin Drummond |
| Contact details | Section of Addictive Behaviour St Georges University of London Cranmer Terrace London United Kingdom SW17 0RE |
| Contact email | sgju970@sgul.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN55274820 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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