Condition category
Mental and Behavioural Disorders
Date applied
25/04/2016
Date assigned
12/05/2016
Last edited
06/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Drunkenness is a common night-time problem in many UK towns and cities. Traditionally, people who are very drunk have either been escorted to a hospital Emergency Departments (ED) so that their health can be monitored or police custody if they commit an offence. Recently the police issued guidance for all UK forces stating that those who are drunk cannot be housed in custody due to possible health complications, unless a clinical decision maker determines that it is safe to do so. The ED is one of the few clinical services available in the evening and this is where most of those who need clinical input end up, typically by ambulance. This places additional demand on overstretched emergency services at a time when they are experiencing unprecedented levels of demand. Alcohol Intoxication Management Services (AIMS) sometimes called “Drunk Tanks” in the media and Alcohol Welfare Centres or Alcohol Treatment Centres (ATCs) elsewhere, are services that provide a safe environment in which drunk people can be assessed, treated if necessary, monitored or referred to hospital (but only if required). The primary goal is to safely divert as many of those who are drunk away from the ED into AIMS to improve the provision of care in EDs,
provide facilities where police, ambulance and others can quickly hand over drunk patients to staff and therefore improve patient experiences of care in the community generally. The aim of this study to test how acceptable AIMS are to their users, how well they work and whether they are cost effective.

Who can participate?
Adults that have attended a AIMS or ED and then discharged after treatment, AIMS staff and other stakeholders (for example, policy makers).

What does the study involve?
This study involves observing people involved in AIMS and interviewing them (for example, health workers and policy makers), interivews with patients being treated in a AIMS and asking people who have used a AIMS or ED to fill in surveys. The questions asked are designed to find out, for example, how AIMS impact on the work practices on frontline staff treating drunken people, how acceptable people find the treatment, and how being treated in an AIMS affects people’s views on treatment in a ED. The researchers also want to find out what impact AIMS may have on ambulance and other health services. This data is also used to make comparison between AIMS areas and those that do not offer AIMS.

What are the possible benefits and risks of participating?
Although the interviews will not address sensitive issues, it may cause the user embarrassment or distress, or they may raise sensitive issues themselves. As the interviews are by telephone rather than face-to-face this will offer an easier way to raise sensitive issues. These risks will be minimized by drawing upon input from the Sheffield Emergency Care Forum (SECF) and Sheffield Addiction Recovery Research Panel (ShARRP) Patient and Public Involvement (PPI) groups to ensure that the interviews are undertaken in a supportive and non-judgmental manner and focus upon the user experience of the service.

Where is the study run from?
Cardiff Alcohol Treatment Centre (UK)

When is the study starting and how long is it expected to run for?
January 2016 to June 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Andy Irving

Trial website

Contact information

Type

Public

Primary contact

Mr Andy Irving

ORCID ID

Contact details

School of Health and Related Research (ScHARR)
Regent Street
Regent Court
Sheffield
S1 4DA
United Kingdom
+44 01142224292
a.d.irving@sheffield.ac.uk

Type

Scientific

Additional contact

Prof Simon Moore

ORCID ID

Contact details

Cardiff University Violence & Society Research Group
School of Dentistry
Cardiff
CF10 3XQ
United Kingdom
+44 029 20744246
mooresc2@cardiff.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30568

Study information

Scientific title

An evaluation of alcohol intoxication management services (AIMS): implications for service delivery, patient benefit and harm reduction

Acronym

EDARA

Study hypothesis

Alcohol Intoxication Management Services (AIMS) are services that provide a safe environment in which drunk people can be assessed, treated if necessary, monitored or referred to hospital if necessary. The primary goal is to safely divert as many of those who are drunk away from the emergency department (ED) into AIMS to improve the provision of care in EDs, provide facilities where police, ambulance and others can quickly hand over drunk patients to staff and therefore improve patient experiences of care in the community generally. The aim of this study is to evaluate the acceptability, effectiveness and cost effectiveness of Alcohol Intoxication Management Services (AIMS).

Ethics approval

Wales REC3, 15/04/2016, ref: 16/WA/0065

Study design

Observational; Design type: Not Specified

Primary study design

Observational

Secondary study design

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute alcohol intoxication

Intervention

WS1 (work strand 1) will use ethnographic studies; observations and interviews with stakeholders, policy makers and practitioners; interviews with patients attending AIMS and surveys of ED and AIMS users. WS1 focuses on four research questions:

1. What is the impact of AIMS on the work practices and professional identities of frontline staff in managing the intoxicated and other related work activities?
2. What are the micro-, meso- and macro-levels factors that contribute to AIMS development and implementation, what are the key ingredients required for successful implementation and what barriers to implementation exist across partnerships?
3. To what extent is treatment in AIMS acceptable to users?
4. To what extent does implementation of an AIMS affect users’ views on treatment in EDs? In WS2 routine data will be analysed to quantify the effect of AIMS in respect of key performance indicators.

WS2 addresses the research question to what extent does AIMS implementation affect key performance indicators in ambulance and health services?

WS3 addresses the question what are the costs of setting up and running an AIMS and what cost savings may be realised elsewhere? WS3 works alongside WS2 and in addition collates data required for cost-efficiency analyses.

Intervention type

Other

Phase

Drug names

Primary outcome measures

ED attendances, measured using routine data collected from participating ED sites. Health & Social Care Information Centre (HSCIC) Hospital Episodes Statistics (HES) and HES A&E data will be sought covering 2010 to most recent accessible records

Secondary outcome measures

The following outcomes will be compared between ATC and control areas:
1. Hospital admissions, assessed using analysis of routine data from health, and ambulance services from 2010 to most recent accessible records)
2. ED key performance indicators, assessed using analysis of performance and routine data from health, and ambulance services from 2010 to most recent accessible records)
3. Ambulance key performance indicators, assessed using analysis of performance and routine data from health, and ambulance services from 2010 to most recent accessible records
4. ED user survey responses, assessed using postal questionnaires from participating A&E sites in January- March 2017)

The following outcomes will be reported descriptively for ATCs:
1. ATC process activities, assessed using analysis of service and routine data from AIMS covering their full operational period
2. Adverse events during or after ATC care assessed using analysis of service and routine data from AIMS covering their full operational period
3. ATC user survey responses assessed using self-completed questionnaire in November- December 2016

Overall trial start date

05/01/2016

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. AIMS staff and other stakeholders
2. AIMS user interviews and questionnaire survey: Any adult who has attended an AIMS and is discharged to their usual place of residence
3. Any adult ED user who registered between the hours of 8pm and 4am on Fridays and Saturdays and was discharged home after ED treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1440; UK Sample Size: 1440

Participant exclusion criteria

1. Staff (non-participant observations and interviews) who decline to participate in the study.
2. Previous participants
3. Inability to provide informed written consent
4. Prisoner or under arrest
5. Vulnerable adults (e.g. learning difficulties)
6. Significant acute illness or pain
7. Persistent intoxication
8. Inability to speak English
9. Deceased (sample of patients to be sent to the DBS (Demographic Batch Service) to confirm)
10. Children or young persons aged under 16 years at the date of their attendance at the ED,
11. Any attendances at Minor Injuries Units or Walk-in Centres
12. Any patients who were admitted to hospital via Medical or Surgical Admissions Units and therefore have not visited the ED Department
13. Any patients who are known to be current inpatients
14. Planned attendances at outpatient clinics which are run within the ED Department (such as fracture clinics)
15. Patients attending primarily to obtain contraception (e.g. the morning after pill), patients who suffered a miscarriage or another form of abortive pregnancy outcome whilst at the hospital, and patients with a concealed pregnancy; these exclusions will be applied by following Picker guidance and according to the usual process for undertaking the Picker Survey at each Trust

Recruitment start date

05/01/2016

Recruitment end date

30/06/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff Alcohol Treatment Centre
71 Bridge Street
Cardiff
CF10 2TS
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

Strategic Development Research and Commercial Division Research and Innovation Services
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

30/06/2019

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes