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
Protocol serial number	PSI04-13
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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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
Health condition(s) or problem(s) studied	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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1999

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	112
Key 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
Key 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
Date of first enrolment	01/01/1996
Date of final enrolment	31/12/1999

Primary Care and Population Sciences

London
N19 3EU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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