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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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (858% higher). 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 |
What the finished NCT00288899 record still lists
NCT00288899 is an interventional study that assigns participants to a tested intervention. The registered 575 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (858% higher).
The record links to 0 conditions, and to 2 interventions - of which Enhanced surgical iMedConsent process (with "repeat back") is the first listed.
NCT00288899 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00288899's enrollment target sits among peer trials
575 32nd of 2000 higher than 1,968 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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