Contact information
Type
Scientific
Primary contact
Prof Peter Tyrer
ORCID ID
Contact details
Division of Neuroscience & Psychological Medicine
Mental Health & Liaison Services Research Group
Imperial College School of Medicine
Paterson Centre
20 South Wharf Road
London
W2 1PD
United Kingdom
+44 (0)171 886 1648/1655
p.tyrer@ic.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBK99XX8
Study information
Scientific title
Acronym
Study hypothesis
1. To compare two models of care management for patients with severe mental illness. These models involve care management functions being provided
i. Internally within a fully integrated NHS team providing a community rehabilitation service (the intervention) and
ii. Externally.
2. To formally test the hypothesis that internal care management will deliver enhanced outcomes of reduced hospitalisation and costs and improved clinical outcome and satisfaction with care, when compared to external care management.
3. To identify aspects of the care management process which distinguish internal and external case management and to assess factors which appear to influence the outcomes observed.
4. With reference to the arrangements implemented in a non-experimental setting (Nottingham) to compare this to the experimental setting to explore the differences between the models.
5. To use the results of both experimental and qualitative investigations to develop a multi-site randomised controlled trials. This will test hypotheses developed on the basis of findings from the proposed study and assess the value of an intervention refined on the basis of both qualitative and qualitative insights from the proposed study.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mental and behavioural disorders: Schizophrenia and other psychoses; Mental and behavioural disorders: Depression, anxiety, neuroses
Intervention
To compare two models of care management for patients with severe mental illness. These models involve care management functions being provided:
i. Internal model of care within a fully integrated NHS team providing a community rehabilitation service (the intervention)
ii. External model of care
Intervention type
Other
Phase
Phase I/II
Drug names
Primary outcome measure
The primary outcome measure will be the duration of psychiatric in-patient card during the six months of the study. This has been found to be a sensitive measure in previous studies and, if integrated care and case management is beneficial, is likely to be demonstrated first in fewer hospital admissions of shorter duration. Secondary outcome measures include number of admissions, improvement in clinical and social functioning, costs and satisfaction with care. Results will be disseminated by workshops and seminars locally in Nottingham and Paddington and more widely at centres in the Trent and North Thames regions: through national conferences; and through publications submitted to peer-reviewed journals covering all mental health disciplines.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1999
Overall trial end date
28/02/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Phase I - 21 interviews (the "internal" CRAFT care manager, 5 CRAFT case managers, 5 "external" care managers with clients from the experimental study population, 5 care managers and 5 NHS care managers from the non experimental setting).
Phase II - 20 patients will be sampled, 10 from each site and both respective care managers and NHS case managers will be interviewed (i.e. 40 interviews).
i. RCT - all patients under the care of CRAFT who are referred for care management between 1 August 1999 and 31 July 2000. Referral criteria include: age between 16-65; diagnosis of severe mental illness; at least 2 hospital admissions in last 10 years; known to existing community or in-patient psychiatric services; under the highest level of the Care Programme Approach; to qualify for care management; to reside in the catchment area of North West London Mental Health NHS Trust.
ii. Cases are to be selected purposively to accommodate range and diversity in order to generate robust explanations and to make valid and reliable generalisations.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1999
Recruitment end date
28/02/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Neuroscience & Psychological Medicine
London
W2 1PD
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive Trent
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://informahealthcare.com/doi/abs/10.1080/09638230400006759