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 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 trial start date
04/01/2000
Overall trial end date
31/03/2004
Reason abandoned (if study stopped)
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
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15240438
Publication citations
-
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.