A randomised controlled trial of a computerised clinical decision support system for the management of psychiatric disorder in primary care.

ISRCTN ISRCTN57116180
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

Psychological Medicine
University of Wales College of Medicine
Monmouth House
Heath Park
Cardiff
CF14 4XN
United Kingdom

Phone +44 (0)29 2074 4394

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeOther
Scientific title
Study objectivesTo 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) studiedSchizophrenia and other psychoses
InterventionCases 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 typeOther
Primary outcome measure12-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 measures1. 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 date01/12/1996
Completion date01/01/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit16 Years
SexBoth
Target number of participants762 individuals from 5 practices (added 01/12/09)
Key inclusion criteria1. 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 criteria1. 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 enrolment01/12/1996
Date of final enrolment01/01/2001

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Psychological Medicine
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

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

Website http://www.doh.gov.uk

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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2004 Yes No