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 |
| Protocol serial number | RBK99XX8 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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 |
|---|---|
| p.tyrer@ic.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
W2 1PD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
