CORE: Crisis Team Optimisation and Relapse Prevention - Phase 3
| ISRCTN | ISRCTN01027104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01027104 |
| Secondary identifying numbers | 15999 |
- Submission date
- 10/10/2012
- Registration date
- 11/10/2012
- Last edited
- 19/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Crisis resolution teams (CRTs) are specialised teams that provide rapid assessment and treatments to people having a mental health crisis. CRTs were introduced in the UK in 2001 in order to improve experiences for people suffering a mental health crisis (sudden breakdown) and to limit the amount of people who were admitted to hospital. Although there have been positive effects of implementing CRTs such as reducing inpatient admissions and lowing healthcare costs, many service users reported issues in the long term, such as continuity of care between services during and following a period of CRT care. The aim of this study is to find out whether working through a self-management workbook with support when leaving CRTs could help to promote recovery and reduce the risk of further episodes (relapse).
Who can participate?
Adults who have been on the caseload of a participating CRT for at least a week.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are offered up to 10 meetings with a peer support worker over a course of four months, who helps them to work through a self-management workbook. The workbook is made up of structured sections, helping the participant to set personal recovery goals, re-establishing their social support network, advice to help prevent the crisis happening again, and planning strategies and coping resources for when the crisis is resolved. Those in the second group are also given the self-management workbook to complete but are given no additional guidance about how to use it. At the start of the study and then after 4 months, participants are interviewed in order to assess how well they are coping. One year after the start of the study, the participants medical records are also reviewed in order to find out about how much they have used mental health services and if they have been admitted to hospital. An additional follow up interview will be completed with participants 18 months after study entry.
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?
February 2014 to April 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Brynmor Lloyd-Evans
b.lloyd-evans@ucl.ac.uk
Contact information
Scientific
Division of Psychiatry
6th Floor, Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom
| Phone | +44 (0)20 7679 9428 |
|---|---|
| b.lloyd-evans@ucl.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Optimising team functioning, preventing relapse and enhancing recovery in Crisis Resolution Teams (CRTs): the CORE Programme (Crisis team Optimisation and RElapse prevention) Phase 3: Randomised controlled trial of a peer provided, self-management intervention for people leaving CRT services |
| Study acronym | CORE Phase 3 |
| Study objectives | Current hypothesis as of 05/02/2014: 1. Provision of a peer-provided, self-management programme for people leaving Crisis Resolution Teams will reduce readmission to acute care over one year follow-up. 2. Provision of a peer supported, self-management programme for people leaving Crisis Resolution Teams will improve satisfaction with services, self-rated recovery, illness management, social inclusion , symptoms and loneliness, social support and neighbourhood social capital at follow-up post-treament and at 18-month follow-up, and reduce inpatient bed use over one year follow-up. Previous hypothesis: 1. Provision of a peer-provided, self-management programme for people leaving Crisis Resolution Teams will reduce readmission to acute care over one year follow-up. 2. Provision of a peer supported, self-management programme for people leaving Crisis Resolution Teams will improve satisfaction with services, self-rated recovery, illness management, employment, symptoms and perceived continuity of care at follow-up post-treament, and reduce inpatient bed use over one year follow-up. |
| Ethics approval(s) | First MREC, 19/07/2012, ref: 12/LO/0988 |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | Current interventions as of 05/02/2014: Peer-provided self management Participants in the treatment group will be offered up to 10 meetings with a peer support worker, who will support them in developing a personal recovery plan using a manualised workbook. Participants in the control group will be given the self-management workbook but no additional guidance or peer support to help use it. Followed up by a research interview after 4 and 18 months and via patient records over 12 months Previous interventions: Peer-provided self management Participants in the treatment group will be offered up to 10 meetings with a peer support worker, who will support them in developing a personal recovery plan using a manualised workbook. Followed up after 6 months |
| Intervention type | Other |
| Primary outcome measure | Re-admission to acute care measured at one year from study entry |
| Secondary outcome measures | Current secondary outcome measures as of 05/02/2014: 1. Days in acute care over 1-year follow-up 2. Time to readmission (1-year follow-up) 3. Mental health service use (1-year follow-up) 4. Illness management measured at 4-month follow-up interview - IMR questionnaire 5. Psychiatric symptoms measured at 4-month follow-up interview - BPRS questionnaire 6. Satisfaction with services measured at 4-month follow-up interview - CSQ questionnaire 7. Self-rated recovery measured at 4-month follow-up - QPR questionnaire 8. Social inclusion at 4-month follow-up SIX questionnaire 9. Loneliness at 4-month follow-up UCLA Loneliness Scale questionnaire 10. Social network at 4-month follow-up Lubben SNS questionnaire 11. Neighbourhood social capital at 4-month follow-up - Health and Lifestyles survey Neighbourhood social capital questionnaire Added 07/12/2016: Outcomes 4-11 will also be assessed at 18 month follow-up. Previous secondary outcome measures: 1. Employment status measured at 4 month follow up interview 2. Illness Management measured at 4 month follow-up interview - IMR questionnaire 3. Inpatient bed days, measured one year following study entry 4. Perceived continuity of care, measured by Continu-um questionnaire at 4 month follow-up 5. Psychiatric symptoms measured at 4 month follow up interview - BPRS questionnaire 6. Satisfaction with services measured at 4 month follow-up interview - CSQ questionnaire 7. Self-rated recovery measured at 4 month follow up - QPR questionniare |
| Overall study start date | 01/04/2011 |
| Completion date | 30/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 440 |
| Key inclusion criteria | Current inclusion criteria as of 05/02/2014: 1. Adults (aged 18+) who have been on the caseload of a participating Crisis Resolution Team for at least a week 2. Male and female 3. A threshold has been set that at least half the participants recruited must be identified during screening at services as having schizophrenia or other psychosis or bipolar disorder Previous inclusion criteria: 1. Adults (aged 18+) who have been on the caseload of a participating Crisis Resolution Team for at least a week 2. Male and female |
| Key exclusion criteria | Current exclusion criteria as of 05/02/2014: 1. People who lack capacity to consent to take part in the study 2. People who in the view of the clincal team at their Crisis Resolution Team present such a high risk of harm to others, it would be unsafe for researchers or peer support workers to meet with them even in a mental health service setting 3. People who are discharged to addresses outside the catchment area 4. People who cannot understand the intervention when delivered in English Previous 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 or peer support workers to meet with them even in a mental health service setting 3. People who are already on the caseloads of a highly intensive community service, such as an Assertive Outreach Team 4. People who are discharged to addresses outside the catchment area 5. People who cannot understand the intervention when delivered in English |
| Date of first enrolment | 06/02/2014 |
| Date of final enrolment | 03/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W1 7EJ
United Kingdom
Sponsor information
Hospital/treatment centre
Research and Development Department
Bloomsbury Building
St Pancras Hospital
4 St Pancras Way
London
NW1 0PE
England
United Kingdom
| Website | http://www.candi.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03ekq2173 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/10/2017 | Yes | No | |
| Other publications | intervention development | 09/11/2017 | Yes | No | |
| Results article | results | 04/08/2018 | Yes | No | |
| Results article | results | 01/04/2019 | 16/04/2019 | Yes | No |
| Other publications | Cost-effectiveness | 02/06/2023 | 19/06/2023 | Yes | No |
Editorial Notes
19/06/2023: Publication reference added.
16/04/2019: Publication reference added.
14/08/2018: Publication reference added.
25/06/2018: Publication reference added.
30/10/2017: Publication reference added.
09/12/2016: The overall trial start date has been updated from 06/02/2014 to 01/04/2011. In addition, the publication and dissemination plan and data sharing plan have been added.
07/12/2016: The outcome measures section has been updated. In addition the overall trial end date has been changed from 31/03/2016 to 30/04/2017 and the recruitment end date has been updated from 31/03/2016 to 03/07/2015.
21/03/2016: Plain English summary added.
05/02/2014: The following changes were made to the trial record
1. The anticipated start date was changed from 02/01/2014 to 06/02/2014
2. The target number of participants was changed from 445 to 440
Other changes are indicated in the corresponding fields.
