Contact information
Type
Scientific
Contact name
Dr Elizabeth Murray
ORCID ID
Contact details
Primary Care and Population Sciences
University College London
Holborn Union Building
Archway Campus
London
N19 3EU
United Kingdom
+44 (0)20 7288 3091
elizabeth.murray@pcps.ucl.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
PSI04-13
Study information
Scientific title
Acronym
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Diagnostic
Patient information sheet
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
Reason abandoned (if study stopped)
Eligibility
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 type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
112
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
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Primary Care and Population Sciences
London
N19 3EU
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2001 | Yes | No |