Condition category
Mental and Behavioural Disorders
Date applied
14/08/2014
Date assigned
14/08/2014
Last edited
07/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Crisis Resolution Teams (CRTs) have been set up across England in the last decade to provide rapid assessment and intensive home treatment for people experiencing mental health crises, and prevent hospital admission when possible. Research suggests CRTs reduce hospital admissions and healthcare costs and increase service users' satisfaction with acute care. However, their impact appears to vary between areas and service users and carers report some areas of dissatisfaction with CRT care. There is still uncertainty about how CRTs should be organised and what the critical ingredients of care are. The aim of this study is to evaluate the impact of a CRT resource kit upon service user satisfaction with CRT care. Resource kits consist of guidance, training materials, and coaching and support for service managers and staff. We think that using the resource kit will decrease hospital admissions and improve staff morale.

Who can participate?
Crisis Resolution Teams (CRTs) in the UK

What does the study involve?
Participating CRTs are randomly allocated to either receive a CRT resource kit over a one-year period, or to not receive a CRT resource kit. Service user satisfaction, hospital admission rates and staff morale are compared between the two groups.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
July 2014 to April 2017

Who is funding the study?
NIHR Programme Grants for Applied Research (UK)

Who is the main contact?
Dr Brynmor Lloyd-Evans
b.lloyd-evans@ucl.ac.uk

Trial website

http://www.ucl.ac.uk/core-study

Contact information

Type

Scientific

Primary contact

Dr Brynmor Lloyd-Evans

ORCID ID

Contact details

Department of Mental Health Sciences
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
-
b.lloyd-evans@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16636

Study information

Scientific title

Optimising team functioning, preventing relapse and enhancing recovery in Crisis Resolution Teams (CRTs): the CORE Programme (Crisis team Optimisation and RElapse prevention) CORE Phase 4: A Cluster Randomised Controlled Trial: Evaluation of implementation of a CRT Resource Kit

Acronym

CORE: Phase 4

Study hypothesis

Aim: The primary aim is to evaluate the impact of a CRT resource kit upon service user satisfaction with CRT care.

Hypothesis: We hypothesise that the implementation of the CRT resource kit will result in an increase in a CRTs fidelity score. Following on from this, we predict that service user satisfaction and perceived continuity of care will be greater in CRTs that receive the resource kit compared to those that do not. In terms of service measures, we hypothesise that teams randomised to receive the resource kit, when compared to those that do not receive the intervention, will have fewer hospital admissions, compulsory admissions and inpatient bed days (adjusting for population size of the catchment area). We also predict that staff morale, wellbeing and job involvement will be greater in teams that receive the resource kit.

Ethics approval

First MREC approval date 13/03/2014, ref: 14/LO/0107

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis

Intervention

This is a multi-site, cluster-randomised controlled trial (with CRT service as the unit of randomisation) comparing outcomes for 15 CRTs that receive a CRT resource kit over a one-year study period, with 10 CRTs that do not.

CORE CRT Resource Kit: The CRT resource kit is a team-level intervention, designed to provide guidance and coaching to help CRT managers and staff implement sustainable changes to service organisation and practice. It will be delivered and supported by a resource kit facilitator in each service.

Follow-Up Length: 12 month(s); Study Entry: Registration and One or More Randomisations

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Service user satisfaction with CRT care measured by Client Satisfaction Questionnaire; Timepoint(s): Approx. 12 months after commencement of intervention compared to baseline

Secondary outcome measures

1. Patient Records Admission Data (admission rates, bed use and readmissions to acute care); Timepoint(s): Admissions and readmissions over 6 months
2. Service user experienced continuity of care measured using Continu-um; Timepoint(s): Approx. 12 months after commencement of intervention compared to baseline
3. The General Health Questionnaire- Staff; Timepoint(s): Baseline and 12 months
4. Maslach Burnout Inventory - Staff; Timepoint(s): Baseline and 12 months
5. The Work Engagement Scale - Staff; Timepoint(s): Baseline and 12 months
6. The Work-Related Acceptance and Action Questionnaire - Staff; Timepoint(s): Baseline and 12 months

Overall trial start date

16/07/2014

Overall trial end date

30/04/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Service user inclusion criteria:
Adults (aged 18+) who have been on the caseload of a participating Crisis Resolution Team for at least a week

CRT inclusion criteria:
UK CRT

Target Gender: Male & Female; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 1265; UK Sample Size: 1265

Participant exclusion criteria

Service user exclusion criteria:
1. People who lack capacity to consent to take part in the study
2. People who in the view of the clinical team at their Crisis Resolution Team present such a high risk of harm to others, it would be unsafe for researchers to contact them about participation, even just by phone or email.
3. People who are discharged to addresses outside the catchment area.
4. People who cannot understand the study information sheet or questionnaire when delivered in English.

CRT exclusion criteria:
1. CRT teams identified in a previous national survey conducted at an earlier stage of the CORE study as already operating at high fidelity (mean item score above 4) - i.e. teams with comparatively little capacity for service improvement
2. CRT teams where major change to the organisation of the service is planned during the duration of the trial
3. CRTs taking part in the concurrent CORE Phase 3 trial

Recruitment start date

16/07/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

Camden and Islington NHS Foundation Trust (UK)

Sponsor details

Early Intervention Services
125-133 Camden High Street
London
NW1 7JR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research Programme Grants for Applied Research (UK); Grant Codes: RP-PG-0109-10078

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27004517

Publication citations

Additional files

Editorial Notes

07/12/2016: The overall trial end date was changed from 31/12/2015 to 30/04/2017. 13/04/2016: Plain English summary added. 23/03/2016: Publication reference added.