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Completed Phase 1 Interventional

Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program

ClinicalTrials.gov ID: NCT00288899

Public ClinicalTrials.gov record NCT00288899. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 1, 2026, 1:31 AM EST

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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".

Study identification

NCT ID
NCT00288899
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
575 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 7, 2006 (Actual)
Primary completion
Mar 31, 2009 (Actual)
Completion
Mar 31, 2009 (Actual)
Last update posted
Jun 6, 2017

2006 – 2009

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
VA Eastern Colorado Health Care System, Denver, CO Denver Colorado 80220 —
James A. Haley Veterans' Hospital, Tampa, FL Tampa Florida 33612 —
Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia 30033 —
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts 02130 —
VA Portland Health Care System, Portland, OR Portland Oregon 97239 —
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania 15240 —
Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00288899, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 6, 2017 · Synced Nov 1, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00288899 live on ClinicalTrials.gov.

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