Randomised controlled trial (RCT) to evaluate a patient-held shared record card for patients with long term mental illness

ISRCTN	ISRCTN37144448
DOI	https://doi.org/10.1186/ISRCTN37144448
Protocol serial number	844
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive West Midlands (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Helen Lester
Scientific

Dept of General Practice
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 3760

Primary study design	Interventional
Study design	Cluster randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	From the viewpoint of both primary and secondary care, what is the effect of a patient held shared record card on the pattern of service use and satisfaction with medical care for people with long term mental illness, compared to current practice?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Schizophrenia and other psychoses
Intervention	Randomly selected patients entered on the North Birmingham Community District Mental Health Team's "community team case load census" database will be randomised: 1. Patient-held records 2. Current practice 100 patients will be required for each arm of the study. To avoid contamination bias, patients in the study and control arm will be drawn from different general practices.
Intervention type	Other
Primary outcome measure(s)	1. Adherence with treatment 2. Loss to follow up 3. Satisfaction with medical care 4. Number of psychiatric admissions/year 5. Length of inpatient stay
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key inclusion criteria	All patients with more than 2 years history of schizophrenia or other psychoses, severe personality disorder, or severe neurosis who require long-term supervision.
Key exclusion criteria	1. Dementia, or other brain disorder 2. Alcohol or drug misuse 3. Learning disability 4. 15 years or under 5. 65 year or older.
Date of first enrolment	01/11/1997
Date of final enrolment	31/07/2001

Dept of General Practice

Birmingham
B15 2TT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2003		Yes	No