Randomised controlled trial (RCT) on qualitative analysis of internal and external care management in severe mental illness

ISRCTN	ISRCTN01712888
DOI	https://doi.org/10.1186/ISRCTN01712888
Secondary identifying numbers	RBK99XX8

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 01/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Tyrer
Scientific

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

Phone	+44 (0)171 886 1648/1655
Email	p.tyrer@ic.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/09/1999
Completion date	28/02/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1999
Date of final enrolment	28/02/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Division of Neuroscience & Psychological Medicine

London
W2 1PD
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2004		Yes	No