A randomised controlled trial of Joint Crisis Plans for people with psychotic illnesses
| ISRCTN | ISRCTN86793925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86793925 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/05/2003
- Registration date
- 19/05/2003
- Last edited
- 07/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Claire Henderson
Scientific
Scientific
Box P029
Community Psychiatry
Health Services Research Department
David Goldberg Building
Institute of Psychiatry
De Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7848 0729 |
|---|---|
| C.Henderson@iop.kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 1. To measure the cost effectiveness of Joint Crisis Plans for people with psychotic illnesses with respect to hospital admission 2. To establish the feasibility of a more definitive RCT of Joint Crisis Plans |
| Ethics approval(s) | Ethics Committees of the South London and Maudsley NHS Trust, Lewisham University Hospital, South West London and Saint George's NHS Trust, and Thames Gateway NHS Trust. Ethical Approval Number: 188/97 |
| Health condition(s) or problem(s) studied | Psychosis and bipolar affective disorder |
| Intervention | Active intervention: Joint Crisis Plan production Introductory meeting Having informed the participant and their keyworker of the allocation, the research worker arranged a meeting between himself, the participant and if possible the keyworker. The aims of this meeting were, first, that the research worker would explain the overall procedure for producing the JCP, and, second, that the keyworker should introduce the JCP menu to the participant, help him or her to identify early warning signs of relapse and formulate possible advance statements to be included. Joint Crisis Planning meeting To finalise the JCP contents the research worker then organised and facilitated at a meeting between the participant, team consultant or other qualified team psychiatrist and keyworker, where the JCP contents were finalised. The participant was encouraged to bring a carer or other to act as an advocate. The research worker's role as facilitator was to act as a neutral third party external to the team. By taking this role, he was in the best possible position to achieve the following aims: 1. To ensure that different options for the menu are explored 2. To help all parties reach consensus wherever possible, such that the participant is happy to carry the JCP and all those it designates to act in future are willing to carry out the designated action 3. If consensus cannot be reached one of two options are chosen by the patient; either the differences are made clear but the JCP retains this title as other contents have been agreed jointly, or, the document is renamed a crisis card because of the lack of joint agreement During the meeting, the contents of the plan were written down by the research worker in the form of the first person and using the exact words agreed on. Checking the JCP content After the planning meeting the research worker produced the typed version of the JCP as an A4 sheet. He then either met with the participant to check the content, or sent him or her the JCP and consulted him or her about the content over the telephone. If the participant wanted changes to be made, the research worker consulted relevant CMHT members if he deemed that the change required the team's agreement first. Distribution Once any further changes had been made, copies were sent by the research worker to all those whom the participant had designated on the menu. The participant was also sent a clear plastic wallet for the JCP. Control intervention The Joint Crisis Plan represents a new form of information held on paper by a patient. It was decided that in order to receive the best available care under usual conditions, the control group should receive whatever information was currently available on paper. At the time this consisted of two types: 1. A copy of the Care Plan done as part of the Care Programme Approach (CPA) 2. Leaflets on local services, different types of mental illness and other aspects of care As all participants should have been given a copy of their care plan if covered by the CPA, and as none of the participating teams routinely gave out the second type of information, it was decided to make the latter the control intervention. Prior to beginning recruitment, the investigator and research worker visited each CMHT base and hospital to which patients from the participating sectors were admitted to collect whatever information was available. Participants in the control group were given whatever was available relating to their CMHT and Trust, plus any other relevant information we had found at their site or elsewhere. The types of information distributed were as follows: Hospital admission (what to expect, what to bring, rules) Mental health resource centres (services available, opening hours) Medication Mental Health Act information booklet for patients ('Out of the Maze') Social Security information on welfare benefits Advocacy services Social Services and voluntary sector information on local services (drop in centres, vocational training etc. Information on mental illnesses Trust policies, e.g. on confidentiality, patients' access to their own notes and making a complaint where available. |
| Intervention type | Other |
| Primary outcome measure | Hospital admission 1. Admitted or not 2. Compulsory admission 2.1. Compulsory admission without police involvement 2.2. Compulsory admission with police involvement 3. Number of days spent in hospital 4. Discharged or not |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 04/01/2000 |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 152 |
| Key inclusion criteria | 1. Patients had first to be currently under the care of one of the recruited community mental health teams. 2.On the day on which the clinical casenotes were consulted to retrieve diagnostic and sociodemographic information, the patient had to have been admitted to a psychiatric inpatient service at least once in the previous two years. 3. They had to have a diagnosis of psychotic illness or bipolar affective disorder without psychotic symptoms, operationalised from the clinical casenotes using the Operational Criteria Checklist, OPCRIT5, which uses a computer algorithm to assign diagnoses according to International Statistical Classification of Diseases and Related Health Problems, Tenth edition (ICD-10), Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) and a number of other diagnostic criteria. Patients were not recruited while staying on a psychiatric ward but if otherwise eligible they were contacted once they had been discharged or sent on extended leave. |
| Key exclusion criteria | Inability to understand the JCP's function through mental incapacity or insufficient command of English to understand the consent procedure. |
| Date of first enrolment | 04/01/2000 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box P029
London
SE5 8AF
United Kingdom
SE5 8AF
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| G.Dale@iop.kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) training fellowship in health services research
No information available
South London and Maudsley NHS Trust (SlaM) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 17/07/2004 | Yes | No |
