Condition category
Mental and Behavioural Disorders
Date applied
30/04/2007
Date assigned
08/06/2007
Last edited
22/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sips.iop.kcl.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Colin Drummond

ORCID ID

Contact details

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

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 measures

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

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

http://www.iop.kcl.ac.uk

Funders

Funder type

Government

Funder name

Department of Health (UK) - part of an action under the government’s 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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

Additional files

Editorial Notes