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

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN37846533
• Date of registration: 23/01/2004
• Prospective Registration: No
• Primary sponsor: Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
• Public title: Randomised controlled trial and cost-effectiveness evaluation of an interactive video system to promote shared decision making in general practice
• Date of first enrolment: 01/01/1996
• Target sample size: 112
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37846533
• Study type: Interventional
• Study design: Randomised controlled trial (Diagnostic)

Countries of recruitment

United Kingdom

Contacts

• Name: Elizabeth Murray

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Urological and genital diseases: Other urological and genital disease
Urological and Genital Diseases
Benign prostatic hypertrophy

Intervention(s)

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.

Primary Outcome(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.

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

PSI04-13

Source(s) of Monetary Support

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