A randomised controlled trial of a computerised clinical decision support system for the management of psychiatric disorder in primary care.
ISRCTN | ISRCTN57116180 |
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DOI | https://doi.org/10.1186/ISRCTN57116180 |
Secondary identifying numbers | PSI02-58 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 21/12/2009
- 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 Glyn Lewis
Scientific
Scientific
Psychological Medicine
University of Wales College of Medicine
Monmouth House
Heath Park
Cardiff
CF14 4XN
United Kingdom
Phone | +44 (0)29 2074 4394 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | GP practice |
Study type | Other |
Scientific title | |
Study objectives | To evaluate the cost-effectiveness, under service conditions, of case finding followed by computer-generated patient-specific clinical practice guidelines, compared with locally-agreed guidelines only, for the management of common mental disorders in primary care. The self-administered computerised assessment included 1. The Revised Clinical Interview Schedule (CIS-R), and 2. A social assessment covering sociodemographic characteristics, any current difficulties in housing, employment, finance and personal relationships, and the availability of social support. In the course of this project, the previous version of the computer program entitled PROQSY (PROgrammable Questionnaire System) was upgraded so as to be compatible with Windows 95 and subsequent versions. Further modifications were also made. These included a method for detecting errors in the questionnaire files (or scripts), an integral randomisation command and new commands to provide more variety in the type face when generating the output for clinicians. The clinical practice guidelines were based on those developed by the World Health Organisation (WHO) for the management of psychiatric disorders in primary care (ICD10-PHC, Goldberg, 1994). These guidelines were discussed with the GPs in all 5 practices and they were given opportunities to alter any of the advice given in the guidelines. We also provided them with a list of local voluntary sector organisations and self-help groups and established whether the GPs regarded these as a useful organisations for patients. These groups were then incorporated in the guidelines. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Schizophrenia and other psychoses |
Intervention | Cases of common mental disorder were identified by case-finding questionnaire and then randomly allocated within practices to 1. An intervention group, in which the GP was given the results of a detailed self-administered computerised psycho-social assessment, combined with patient-specific treatment recommendations, or 2. A control group, in which the GP was not given any additional information or advice, but who had access to a copy of locally agreed clinical practice guidelines. Randomisation was performed by the computer which administered the questionnaires and generated the advice for the GP. The randomisation was therefore concealed from the research assistant and the subject. |
Intervention type | Other |
Primary outcome measure | 12-item General Health Questionnaire (GHQ12) Outcome was assessed at 6 weeks and 6 months. The subjects were sent the questionnaires by post and were reminded by telephone if they did not respond. |
Secondary outcome measures | 1. Quality of life assessed with 6 questions 2. Satisfaction with treatment assessed with 1 question: If a friend were in need of similar help from a general practitioner would you recommend your GP to him/her? 3. Number of consultations in primary care assessed both by asking the subjects, and also by recording the number of consultations in the primary care notes of the subjects 4. In 2 of the practices we recorded the psychotropic medication prescriptions for all those in the trial. |
Overall study start date | 01/12/1996 |
Completion date | 01/01/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 16 Years |
Sex | Both |
Target number of participants | 762 individuals from 5 practices (added 01/12/09) |
Key inclusion criteria | 1. Five general practices in Bristol and Cardiff participated in the study. 2. Eligible subjects were consecutive general practitioner (GP) attenders who were aged 16 years and over who completed the general health questionnaire (GHQ-12). 3. Subjects who had a positive GHQ score (i.e. >3) and who achieved a score of 12 or more on the CIS-R (Computerised Interview Schedule [Reduced]) were randomised. |
Key exclusion criteria | 1. A previous diagnosis of a psychotic illness 2. A mental handicap or cognitive impairment 3. Language or literacy difficulties 4. A severe or terminal physical illness |
Date of first enrolment | 01/12/1996 |
Date of final enrolment | 01/01/2001 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Psychological Medicine
Cardiff
CF14 4XN
United Kingdom
CF14 4XN
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
NHS Primary and Secondary Care Interface National Research and Development Programme (UK)
No information available
Results and Publications
Intention to publish date | |
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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? |
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Results article | results | 01/11/2004 | Yes | No |