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NCT00288899 · ClinicalTrials.gov registry record · Phase 1
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 575
- Enrollment target
NCT00288899: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT00288899 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 575 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00288899, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 575 participants
- Enrollment target
Study Summary
This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and radical prostatectomy). Baseline covariates include health status (SF-12), reading ability (REALM), and demographics. Primary outcomes are patient comprehension of the informed consent, patient satisfaction with the informed consent and decision making processes, patient satisfaction with care, anxiety (STAI), and provider assessment of the "repeat back" process. In addition, we are electronically capturing data detailing time spent in each phase of the consent process including "repeat back".
Interventions
- OTHER Enhanced surgical iMedConsent process (with "repeat back")
- OTHER standard surgical iMedConsent process
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2006-08-07 |
| Est. Completion | 2009-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00288899
The ClinicalTrials.gov registry entry for NCT00288899 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Enhanced surgical iMedConsent process (with "repeat back") is the first listed.
NCT00288899 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00288899 about?
NCT00288899 is a clinical study titled "Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program". This is a VA Merit Review Study involving 7 VA medical centers participating in a parallel group randomized trial comparing "repeat back" versus standard electronic consent for 4 common elective surgical procedures (total hip arthroplasty, carotid endarterectomy, laparoscopic cholecystectomy, and ra...
What is the current status of trial NCT00288899?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 575 participants. The study started on 2006-08-07. Estimated completion is 2009-03-31.
What interventions are being tested in trial NCT00288899?
The interventions under investigation include: Enhanced surgical iMedConsent process (with "repeat back") (OTHER), standard surgical iMedConsent process (OTHER).
Who is sponsoring clinical trial NCT00288899?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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