Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PSI02-58
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled 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
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
Phase
Not Applicable
Drug names
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 trial start date
01/12/1996
Overall trial end date
01/01/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
762 individuals from 5 practices (added 01/12/09)
Participant 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
Recruitment start date
01/12/1996
Recruitment end date
01/01/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Psychological Medicine
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Primary and Secondary Care Interface National Research and Development Programme (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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15527609
Publication citations
-
Results
Thomas HV, Lewis G, Watson M, Bell T, Lyons I, Lloyd K, Weich S, Sharp D, Computerised patient-specific guidelines for management of common mental disorders in primary care: a randomised controlled trial., Br J Gen Pract, 2004, 54, 508, 832-837.