Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/12/2010
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

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2004 results in http://informahealthcare.com/doi/abs/10.1080/09638230400006759

Publication citations

Additional files

Editorial Notes