Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SIPS-PHC
Study information
Scientific title
Pragmatic cluster randomised controlled trial evaluating the effectiveness and cost-effectiveness of primary health care screening and brief alcohol intervention
Acronym
SIPS (PHC)
Study hypothesis
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
London Local Research Ethics Committees (LREC) approved on the 30th March 2007 (ref: 06/MRE02/90)
Study design
Pragmatic cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/04/2007
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
744
Participant 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
Recruitment start date
01/04/2007
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Section of Alcohol Research
London
SE5 8BB
United Kingdom
Sponsor information
Organisation
Institute of Psychiatry, Kings College London (UK)
Sponsor details
4 Windsor Walk
London
SE5 8BB
United Kingdom
paolo.deluca@iop.kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Department of Health (UK) - part of an action under the governments Alcohol Harm Reduction Strategy for England (2004)
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
Basic results (scientific)
Publication list
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19664255
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23303891
Publication citations
-
Protocol
Kaner E, Bland M, Cassidy P, Coulton S, Deluca P, Drummond C, Gilvarry E, Godfrey C, Heather N, Myles J, Newbury-Birch D, Oyefeso A, Parrott S, Perryman K, Phillips T, Shenker D, Shepherd J, Screening and brief interventions for hazardous and harmful alcohol use in primary care: a cluster randomised controlled trial protocol., BMC Public Health, 2009, 9, 287, doi: 10.1186/1471-2458-9-287.
-
Results
Kaner E, Bland M, Cassidy P, Coulton S, Dale V, Deluca P, Gilvarry E, Godfrey C, Heather N, Myles J, Newbury-Birch D, Oyefeso A, Parrott S, Perryman K, Phillips T, Shepherd J, Drummond C, Effectiveness of screening and brief alcohol intervention in primary care (SIPS trial): pragmatic cluster randomised controlled trial., BMJ, 2013, 346, e8501.