Condition category
Mental and Behavioural Disorders
Date applied
27/02/2018
Date assigned
29/03/2018
Last edited
29/03/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
In-patient wards can be stressful places for service users, carers and staff and incidence of violence and self-harm are not uncommon. Previous research has shown that self-harm, suicide, aggression and violence are less likely in in-patient services that protect patient rights, manage conflict between patients, have clean, comfortable, spacious and well-maintained wards, have systems in place to support patients when they receive bad news, and have highly skilled staff who are well supported by managers. The skills that staff use in response to early signs of aggression and self-harm (de-escalation techniques) are known to be very important, both in terms of safely reducing the behaviours and avoiding the need for potentially harmful practices such as physical restraint. Although all UK National Health Service staff are trained in de-escalation techniques, recent research has shown that practices such as restraint continue to be used more often than they should be. One possible reason for this is that there is no current model of training proven by research to be effective. Developing and evaluating a new type of training is therefore urgently needed to improve safety and the ward environment. The aim of this study is to develop and test a new training package that will provide staff with skills (called de-escalation techniques) to help to safely reduce anger and distress.

Who can participate?
Patients and carers, mental health nurses, nursing assistants, occupational therapists, occupational therapy assistants, psychiatrists, clinical psychologists, assistant psychologists, service managers and PMVA training staff

What does the study involve?
All available scientific evidence on de-escalation techniques is gathered, along with the views of service users, carers and relatives, staff, hospital managers and training staff on the best ways of helping to calm people who are distressed without using practices like physical restraint and forced medicines. This information is used to develop new training, which is then tested to see whether the training improves the way staff communicate with distressed people in role-plays, and whether it reduces violence, aggression and use of restraints and isolation rooms in practice. The conflict de-escalation training package (EDITION) is delivered for all ward staff in each of the ten wards to supplement existing NHS Prevention and Management of Violence and Aggression (PMVA) training. Training is collaboratively delivered by PMVA training staff at the two participating Mental Health Trusts and service users and carers. Frontline clinical staff receive one day’s training (8 hours). Clinical leads receive an additional half-days training (4 hours). Mental health nurses in each of the wards are identified to adopt ‘intervention champions’ roles. Champions receive an additional half-day’s training. There is then an eight-week period to embed learning and implement the developed guidance. There is then a further eight weeks follow-up data collection period.

What are the possible benefits and risks of participating?
This study implements training designed to change staff use of interventions intended to maintain safety (de-escalation techniques). A risk of the study is therefore an unintended increase in unsafe events such as violence occurring as a result of the new training. This is low risk but is minimised by involving staff and patients in the development of the training work. There is a rigorous system for reporting adverse events during the implementation of the training package and the training is stopped if necessary.

Where is the study run from?
South West Yorkshire Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
September 2016 to June 2020

Who is funding the study?
NIHR Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Owen Price
owen.price@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Owen Price

ORCID ID

http://orcid.org/0000-0002-4601-3363

Contact details

Jean McFarlane Building
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7877
owen.price@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 16/101/02

Study information

Scientific title

Enhancing de-escalation techniques in adult acute and forensic units: development and evaluation of an evidence-based training intervention

Acronym

EDITION

Study hypothesis

This research aims to develop and evaluate an evidence-based training package to enhance the implementation and effectiveness of de-escalation techniques in practice. The objectives include:
1. Develop with stakeholders an effective, acceptable and context-sensitive de-escalation training package for mental health staff
2. Evaluate training package effects on use and effectiveness of de-escalation and rates of restrictive practices
3. Explore the processes underpinning training implementation and impact and understand the individual and organisational factors inhibiting or enabling routine use

Ethics approval

Yorkshire & The Humber - South Yorkshire Research Ethics Committee, 01/02/2018, ref: 18/YH/0035

Study design

Mixed-method uncontrolled 24-week case series evaluation

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Conflict behaviours (self-harm/suicidal crisis, medication-refusal, absconding, drug/alcohol misuse, rule-breaking, aggression/violence)

Intervention

A dedicated conflict de-escalation training package (EDITION) will be delivered for all ward staff in each of the ten wards to supplement existing NHS Prevention and Management of Violence and Aggression (PMVA) training. The trialists will train approximately 30 staff per ward (n=10). Intervention content will be co-developed with multiple stakeholders, including service users, carers and health professionals. Session content will be informed by two systematic reviews and qualitative investigations with patients, carers and qualified and unqualified mental health staff. Training will be collaboratively delivered by PMVA training staff at the two participating Mental Health Trusts and service users and carers. Frontline clinical staff will receive one day’s training (8 hours). Clinical leads will receive an additional half-days training (4 hours). There will then be an eight week period to embed learning and implement the developed guidance. There will then be a further eight weeks follow-up data collection period.

Evidence-based and contextually sensitive, training implementation guidance will be developed to supplement the face-to-face training. Systematic reviews suggest that multifaceted approaches that combine interactive education, with stakeholder consensus processes and local opinions leaders/champions may be most effective in promoting practice change. The trialists have identified mental health nurses in each of the intervention wards who will adopt ‘intervention champions’ roles. Champions will receive an additional half-day’s training.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Feasibility: recruitment and retention rates, intervention uptake and engagement rates, full and partial completion rates for the proposed outcome measures and variability and potential floor and ceiling effects in these outcomes
2. Adverse events (AEs), reported at regular intervals to the steering committee

Secondary outcome measures

Staff-reported outcomes:
1. Conflict and containment: The PCC-SR, a validated measure of conflict and containment rates, will be completed by the nurse-in-charge at the end of every shift. The PCC-SR will be completed for each the 10 participating wards, throughout the full 24 weeks of data collection (8 weeks pre-training implementation, 8 weeks implementation and 8 weeks post-training implementation).
2. De-escalation performance: assessed immediately pre-and-post-training. Each consenting participant will be video-recorded pre-and-post training completing a standardised role play. Each recording will be coded by researchers to identify whether it was recorded pre or post-training. Recordings will be sent to independent external raters who will be blinded to pre-or-post-training designation and who will rate performance using the De-escalating Aggressive Behaviour Scale (EM-DABS), a validated observer-rated measure of de-escalation performance.
3. Training acceptability: assessed via the Training Acceptability Rating Scale (TARS) which measures knowledge, confidence, applicability, quality and satisfaction of training. The TARS will be completed by all consenting participants at a single time-point immediately post-training.
4. Capabilities, opportunities, and motivations to use de-escalation techniques: a 7-item COM-B questionnaire assesses physical capability, psychological capability, physical opportunity, social opportunity, conscious motivation, automatic motivation as well as behaviour in relation to using de-escalation techniques. This measure will be completed by staff at four time-points: Week 1 and 8 of the pre-implementation and Week 16 and 24 of the post-implementation data collection period.
5. Attitudes to containment: 11 items rated on a scale that rates staff perceptions of the acceptability of containment methods.This measure will be completed by staff at four time-points: Week 1 and 8 of the pre-implementation and Week 16 and 24 of the post-implementation data collection period.
6. Attitudes to personality disorder: The Attitudes to Personality Disorder Questionnaire (APDQ) is a 10-item measure of nursing attitudes to patients with personality disorder. This measure will be completed by staff at four time-points: Week 1 and 8 of the pre-implementation and Week 16 and 24 of the post-implementation data collection period.

Patient-reported outcomes:
1. Coercion experience: The Coercion Experience Scale (CES) is a 44-item measure of the psychological impact of coercive measures on patients. This measure will be completed by patients at 7 time-points: Weeks, 1, 4 and 8 in the pre-implementation phase; week 12 in the embedding phase; weeks 16, 20 and 24 in the post-implementation phase.
2. Perceived expressed emotion in staff: The Perceived Expressed Emotion in Staff Scale (PEESS) is a 20-item measure. This measure will be completed by patients at 7 time-points: Weeks, 1, 4 and 8 in the pre-implementation phase; week 12 in the embedding phase; weeks 16, 20 and 24 in the post-implementation phase.

Economic outcomes:
1. Health status: The EQ-5D-5L will be used to assess staff and patient health status and Quality Adjusted Life Years (QALYs). It has two parts: part one has 5 items (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) rated on 5 levels between no problems and severe problems. Part two is a visual analogue scale which asks participants to rate their overall health on a scale between 0-100.
2. Service use: The service use associated with the current and new training package will be collected. These include: inpatient stay pre and post the intervention (via case note review); staff time and resources required to provide and implement current and new training packages (time of trainers, supervisors plus time of trainees to attend training); staff time and resources required to manage episodes of disturbed behaviour/violence (via structured surveys completed by staff).
The EQ5D5L and service use questionnaires will be collected for staff at four timepoints (week 1 and 8 in the pre-implementation and week 16 and 24 of the post-implementation data collection period) and by patients at 7 timepoints (weeks 1, 4 and 8 in the pre-implementation period; week 12 in the embedding phase; weeks 16, 20 and 24 in the post-implementation phase).

Overall trial start date

01/09/2016

Overall trial end date

01/06/2020

Reason abandoned

Eligibility

Participant inclusion criteria

All patients with capacity to provide consent in the target settings and carers, mental health nurses, nursing assistants, occupational therapists, occupational therapy assistants, psychiatrists, clinical psychologists, assistant psychologists, service managers and PMVA training staff.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

550

Participant exclusion criteria

1. Learning disabilities services, later life mental health services and child and adolescent mental health services
2. Student nurses

Recruitment start date

01/10/2019

Recruitment end date

01/06/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South West Yorkshire Partnership NHS Foundation Trust
Fieldhead Ouchthorpe Lane
Wakefield
WF1 3SP
United Kingdom

Trial participating centre

West London Mental Health NHS Trust
Trust Headquarters 1 Armstrong Way
Southall
UB2 4SD
United Kingdom

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7606
lynne.macrae@manchester.ac.uk

Sponsor type

University/education

Website

manchester.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study protocol will be available by 01/07/2019. The trialists will publish findings in a high-impact peer reviewed journal by 01/06/2021 and present their findings at national and international conferences.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/06/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes