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
Protocol serial number	PSI02-58
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	16 Years
Sex	All
Target sample size at registration	762
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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