Condition category
Mental and Behavioural Disorders
Date applied
30/04/2007
Date assigned
08/06/2007
Last edited
26/06/2014
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 Addictive Behaviour
Division of Mental Health
St George's University of London
Cranmer Terrace
London
SW17 0RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SIPS-AED

Study information

Scientific title

A randomised controlled trial of different methods of alcohol screening and brief interventions in routine accident and emergency department care

Acronym

SIPS (AED)

Study hypothesis

Brief intervention by an alcohol health worker for hazardous and harmful drinkers identified by targeted screening is more effective and cost effective than brief advice conducted by Accident and Emergency Department (AED) staff in the typical AED setting.

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 Ethic Committee (LREC), 05/04/2007, ref: 07/MRE02/6

Study design

Cluster prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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

Alcohol use disorders/accident and emergency

Intervention

1. Control condition: AED staff in the control condition will be trained to apply the appropriate screening method and record the screening outcome, will feedback the result of screening to patients and offer them a Patient Information Leaflet (PIL). The PIL is from the “Drink-Less Programme” and has been extensively pre-tested with clinicians and patients in PHC and will be used in this trial. The PIL will also contain a number for Drinkline where the patient can access further information. The PIL to be used in this trial will be ‘Alcohol and Sensible Drinking’ as in the PHC study (trial details in http://www.controlled-trials.com/ISRCTN06145674/).

2. Simple structured advice condition: AED staff will be trained to carry out screening and deliver up to 5 minutes of brief advice for hazardous and harmful drinkers presenting to the AED, using the Drink-Less brief intervention materials (level 1) as in the PHC study. Patients in this condition will also receive a PIL as above, including a number for Drinkline.

3. Alcohol Health Worker condition: This is based on the St Mary’s Hospital model. AED staff will be trained to carry out universal alcohol screening and to refer hazardous and harmful drinkers identified by screening to an Alcohol Health Worker (AHW), by making an appointment usually the following day or as soon as possible after AED attendance. Before leaving the AED the patients in this condition will be given a PIL and “Simple structured advice” as above. The AHW will be experienced in carrying out alcohol assessment and brief interventions. The AHW will carry out a brief lifestyle counseling intervention lasting for 15-20 minutes as in the protocol for PHC lifestyle counseling intervention above (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. Alcohol Problems Questionnaire
2. EQ-5D questionnaire (quality of life assessment)
3. Service utilisation
4. Staff attitudinal and organisational measures

Overall trial start date

01/04/2007

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. AED patients
2. Scoring positive on the Paddington Alcohol Test (PAT), FAST or SASQ
3. Patients who are alert and orientated
4. Aged 18 or over, either sex
5. Able to speak English sufficiently well to complete study questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1179

Participant exclusion criteria

1. Already in contact with alcohol services
2. Those already included in the study
3. Those requesting help with alcohol problems at a tertiary level

Recruitment start date

01/04/2007

Recruitment end date

30/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Section of Addictive Behaviour
London
SW17 0RE
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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24963731

Publication citations

  1. Results

    Drummond C, Deluca P, Coulton S, Bland M, Cassidy P, Crawford M, Dale V, Gilvarry E, Godfrey C, Heather N, McGovern R, Myles J, Newbury-Birch D, Oyefeso A, Parrott S, Patton R, Perryman K, Phillips T, Shepherd J, Touquet R, Kaner E, The effectiveness of alcohol screening and brief intervention in emergency departments: a multicentre pragmatic cluster randomized controlled trial., PLoS ONE, 2014, 9, 6, e99463, doi: 10.1371/journal.pone.0099463.

Additional files

Editorial Notes