Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
844
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Cluster randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1997
Overall trial end date
31/07/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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.
Recruitment start date
01/11/1997
Recruitment end date
31/07/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of General Practice
Birmingham
B15 2TT
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
Funders
Funder type
Government
Funder name
NHS Executive West Midlands (UK)
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
Basic results (scientific)
Publication list
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14694695
Publication citations
-
Results
Lester H, Allan T, Wilson S, Jowett S, Roberts L, A cluster randomised controlled trial of patient-held medical records for people with schizophrenia receiving shared care., Br J Gen Pract, 2003, 53, 488, 197-203.