Contact information
Type
Scientific
Primary contact
Prof Colin Drummond
ORCID ID
Contact details
Section of Addictive Behaviour
St Georges University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom
sgju970@sgul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
STEPWICE
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.
Ethics approval
Iechyd Morgannwg Health Local Research Ethics Committee approval gained on 5th July 2000.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Alcohol Use Disorders
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/06/2000
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
236
Participant 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
Recruitment start date
01/06/2000
Recruitment end date
31/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Addictive Behaviour
London
SW17 0RE
United Kingdom
Sponsor information
Organisation
Wales Office of Research and Development (UK)
Sponsor details
National Assembly for Wales
Cardiff Bay
Cardiff
CF99 1NA
United Kingdom
+44 (0)29 2082 5111
WORD.Wales@gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Wales Office of Research and Development (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
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19880936
Publication citations
-
Results
Drummond C, Coulton S, James D, Godfrey C, Parrott S, Baxter J, Ford D, Lervy B, Rollnick S, Russell I, Peters T, Effectiveness and cost-effectiveness of a stepped care intervention for alcohol use disorders in primary care: pilot study., Br J Psychiatry, 2009, 195, 5, 448-456, doi: 10.1192/bjp.bp.108.056697.