Randomised controlled trial and cost-effectiveness evaluation of an interactive video system to promote shared decision making in general practice

ISRCTN	ISRCTN37846533
DOI	https://doi.org/10.1186/ISRCTN37846533
Secondary identifying numbers	PSI04-13

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Elizabeth Murray
Scientific

Primary Care and Population Sciences
University College London
Holborn Union Building
Archway Campus
London
N19 3EU
United Kingdom

Phone	+44 (0)20 7288 3091
Email	elizabeth.murray@pcps.ucl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Diagnostic
Scientific title
Study hypothesis	To determine whether a decision aid on benign prostatic hypertrophy influences decision making, health outcomes, and resource use.
Ethics approval(s)	Not provided at time of registration
Condition	Urological and genital diseases: Other urological and genital disease
Intervention	Patients with clinical diagnosis of benign prostatic hypertrophy were referred into the study by their General Practitioner (GP). The intervention group received an information package consisting of a session with an evidence based interactive video disc plus printout plus booklet; the control group received normal care only. Data were collected at baseline, three months and nine months.
Intervention type	Other
Primary outcome measure	Patients' and general practitioners' perceptions of who made the decision, decisional conflict scores, treatment choice and prostatectomy rate, American Urological Association symptom scale, costs, anxiety, utility, and general health status.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1996
Overall study end date	31/12/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	112
Participant inclusion criteria	1. Men attending participating general practices with a clinical diagnosis of benign prostatic hypertrophy and sufficient command of English to consult without an interpreter 2. Any clinical suggestion of carcinoma of the prostate 3. Chronic retention of urine 4. Recent urinary tract infection 5. Recent acute urinary retention 6. History of prostate surgery 7. Severe visual or hearing impairment, such that the patient could not use the decision aid 8. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision
Participant exclusion criteria	1. Any clinical suggestion of carcinoma of the prostate 2. Chronic retention of urine 3. Recent urinary tract infection 4. Recent acute urinary retention 5. History of prostate surgery 6. Severe visual or hearing impairment, such that the patient could not use the decision aid 7. Severe learning difficulties or mental illness, such that the patient might not be competent to reach an informed decision
Recruitment start date	01/01/1996
Recruitment end date	31/12/1999

Primary Care and Population Sciences

London
N19 3EU
United Kingdom

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

Government

NHS Primary and Secondary Care Interface National Research and Development Programme (UK)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/09/2001		Yes	No