Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Peter Tyrer


Contact details

Division of Neuroscience & Psychological Medicine
Mental Health & Liaison Services Research Group
Imperial College School of Medicine
Paterson Centre
20 South Wharf Road
W2 1PD
United Kingdom
+44 (0)171 886 1648/1655

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Mental and behavioural disorders: Schizophrenia and other psychoses; Mental and behavioural disorders: Depression, anxiety, neuroses


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


Participant exclusion criteria

Not provided at time of registration

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Division of Neuroscience & Psychological Medicine
W2 1PD
United Kingdom

Sponsor information


NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

NHS Executive Trent

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes