Condition category
Mental and Behavioural Disorders
Date applied
19/05/2003
Date assigned
19/05/2003
Last edited
07/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Claire Henderson

ORCID ID

Contact details

Box P029
Community Psychiatry
Health Services Research Department
David Goldberg Building
Institute of Psychiatry
De Crespigny Park
Camberwell
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0729
C.Henderson@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

04/01/2000

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

152

Participant exclusion criteria

Inability to understand the JCP's function through mental incapacity or insufficient command of English to understand the consent procedure.

Recruitment start date

04/01/2000

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box P029
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7836 5454
G.Dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) training fellowship in health services research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

South London and Maudsley NHS Trust (SlaM) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15240438

Publication citations

  1. Results

    Henderson C, Flood C, Leese M, Thornicroft G, Sutherby K, Szmukler G, Effect of joint crisis plans on use of compulsory treatment in psychiatry: single blind randomised controlled trial., BMJ, 2004, 329, 7458, 136, doi: 10.1136/bmj.38155.585046.63.

Additional files

Editorial Notes