Condition category
Mental and Behavioural Disorders
Date applied
27/01/2020
Date assigned
04/02/2020
Last edited
09/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

Plain English Summary

Background and study aims
In the UK, around 6000 people take their own life each year, causing suffering to those they leave behind. The risk of suicide is 100s of times greater among people who self-harm than among the general population, with 15-43% of people attending the Emergency Department (ED) with self-harm in the year before death. For this reason, the Government’s Suicide Prevention Strategy has identified those presenting with self-harm as a priority group. Each year, around 220,000 episodes of self-harm by 150,000 people are managed by EDs in England. Most EDs have a psychiatric liaison team of specialist mental health practitioners who conduct psychosocial assessments to engage patients, assess their current and future health and social care needs and make onward referrals. However, assessments are often inadequate due to limited capacity in these services and patients often not attending or dropping out, emphasising the need for effective intervention. An appropriate brief intervention which changes routine meetings with patients in the ED could reach around 220,000 patient contacts each year in England. Evidence from recent international trials indicates that such interventions delivered by specialist mental health practitioners in EDs are effective in reducing self-harm and suicide. Training existing mental health teams to deliver the intervention would be relatively cheap, making wider rollout in the NHS attractive. Based on existing international evidence and feedback from all stakeholders, this study aims to pilot the intervention across four Emergency Departments in England. This pilot study forms part of a National Institute for Health Research (NIHR) funded research programme. In this pilot study, the intervention will be tested at four EDs around London, with 16 practitioners and 96 patients. Feedback will be collected on the intervention from patients, carers and practitioners, so that we can learn about potential barriers to implementation and this will lead to further development of the intervention. Assuming the pilot study is successful and acceptable to participants, the next phase will be a large scale cluster randomized controlled trial across 26 Emergency Departments in England.

Who can participate?
Patients aged 16 and over who present to the recruiting Emergency Departments having self-harmed.

What does the study involve?
Participants who are identified as eligible for the study will be offered an adapted therapeutic assessment and enhanced safety planning with the practitioner they see in the Emergency Department. They will then be offered three follow up appointments with the same practitioner over a three-month period. A six-month outcome assessment will then be carried out. Interviews will be carried out with patients, carers and practitioners, to inform the ongoing development of the intervention, in preparation for a future cluster randomized controlled trial.

What are the possible benefits and risks of participating?
Participating in a study whilst people are in distress may present a risk of further distress to people who are emotionally vulnerable. If the practitioners or the researchers feel that the research is too overwhelming, they will stop the process immediately. Our Lived Experience Advisory Panel (LEAP), confirmed that while there is the possibility of causing additional distress, participating in the study may also be beneficial to patients as it may help people feel that they are contributing and are able to help improve services. There are also benefits in terms of being able to talk and being listened to.

Where is the study run from?
1. Newham University Hospital (UK)
2. St Helier Hospital (UK)
3. East Surrey Hospital (UK)
4. St Peter Hospital (UK)

When is the study starting and how long is it expected to run for?
February 2020 to November 2020

Who is funding the study?
Programme Grants for Applied Research, National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Sally O'Keeffe (public)
Sally.OKeeffe@city.ac.uk
Prof Rose McCabe (scientific)
Rose.McCabe@city.ac.uk

Trial website

https://www.city.ac.uk/assuredproject

Contact information

Type

Public

Primary contact

Dr Sally O'Keeffe

ORCID ID

https://orcid.org/0000-0002-6713-2898

Contact details

Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
+44 (0)2070405323
Sally.OKeeffe@city.ac.uk

Type

Scientific

Additional contact

Prof Rose McCabe

ORCID ID

Contact details

Myddelton Street Building
1 Myddelton Street
London
EC1R 1UW
United Kingdom
+44 (0)20 7040 4333
Rose.McCabe@city.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3.0, IRAS 257373

Study information

Scientific title

ASsuRED: Improving outcomes in patients who self-harm - Adapting and evaluating a brief pSychological inteRvention in Emergency Departments

Acronym

ASsuRED

Study hypothesis

This study aims to address four research questions:
1. Can practitioners implement a brief psychological intervention to patients presenting in the Emergency Department to improve care in routine practice in the NHS?
2. What barriers and facilitators to implementing the intervention are experienced by practitioners, patients and carers?
3. Is it feasible for patients to rate outcome measures in the Emergency Department setting for a randomized controlled trial?
4. What are the main resources involved in implementing the intervention?

Ethics approval

Approved 27/07/2019, London - Surrey Borders Research Ethics Committee (Health Research Authority, Skipton House, 80 London Road, London, SE1 6LH; +44 (0)207 104 8134; NRESCommittee.London-SurreyBorders@nhs.net), ref: 19/LO/0778

Study design

Interventional non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Self-harm

Intervention

The ASsuRED pilot study is a single-arm trial taking place across four sites. Participants who present to Emergency Departments having self-harmed will be recruited and will be offered a brief psychological intervention. The intervention will be delivered by practitioners in liaison psychiatry teams, who currently offer a risk assessment to patients. The practitioners will be trained to deliver a therapeutic risk assessment with enhanced safety planning, with follow up care after the patient leaves the Emergency Department. The patient will receive a phonecall within 72-hours of leaving the Emergency Department, and three follow-up meetings at 1-, 4- and 8-weeks, which will be based on a solution-focused approach to supporting the patient. Follow up contact will be offered by the same practitioner that the patient met in the Emergency Department. Longer term contact over 9-months will be offered through regular letters from the practitioner.

Sixteen practitioners will implement the intervention with up to 6 patients each providing 96 practitioner-patient dyads. Practitioners will be trained in delivering the intervention. Identified barriers to implementation and feedback on outcomes will be collected and synthesised to guide refinement of the intervention, and this data will be collected using interviews with patients, carers and practitioners.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Repeat self-harm identified by searching Emergency Department electronic records at the end of the study

Secondary outcome measures

At baseline and six months follow up:
1. Therapeutic relationship, self-rated by patients on the Helping Alliance Scale
2. Self-reported self-harm
3. Suicide severity from the Columbia–Suicide Severity Rating scale
4. Beck Depression Inventory
5. Beck Hopelessness Scale
6. Quality of life measured with CORE-OM
7. Death by suicide, i.e., cause of death is intentional self-harm or undetermined intent derived from NHS/ local authority/coroner records

Overall trial start date

01/05/2019

Overall trial end date

01/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. >16 years of age
2. Presenting in the ED
3. Presenting with self-harm, i.e., an intentional act of self-poisoning or self-injury, irrespective of the motivation or apparent purpose of the act
4. On presenting to the ED, can be admitted for a brief admission to the acute hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Admitted to a psychiatric hospital
2. Cognitive (e.g. dementia) or other psychiatric difficulties interfering with ability to participate
3. Experiencing a psychotic episode
4. No capacity to provide written informed consent
5. Needing an interpreter
6. Ministry of Justice patients subject to a restriction order

Recruitment start date

04/02/2020

Recruitment end date

01/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newham University Hospital
Glen Road Plaistow
London
E13 8SL
United Kingdom

Trial participating centre

St Helier Hospital
Wrythe Lane
Carshalton
SM5 1AA
United Kingdom

Trial participating centre

East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
United Kingdom

Trial participating centre

St Peter Hospital
Guildford Road
Chertsey
KT16 0PZ
United Kingdom

Sponsor information

Organisation

Devon Partnership NHS Trust

Sponsor details

Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom
+44 (0)1392 674114
tobit.emmens@nhs.net

Sponsor type

Hospital/treatment centre

Website

Organisation

City, University of London

Sponsor details

Myddelton Street Building
1 Myddelton Street
Clerkenwell
EC1R 1UW
United Kingdom
+44 (0)20 7040 5704
a.welton@city.ac.uk

Sponsor type

University/education

Website

http://www.city.ac.uk

Funders

Funder type

Government

Funder name

Programme Grants for Applied Research

Alternative name(s)

NIHR Programme Grants for Applied Research, PGfAR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

30/11/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2020: Due to current public health guidance, recruitment for this study has been paused. 03/02/2020: Trial’s existence confirmed by London - Surrey Borders Research Ethics Committee.