At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 575 enrolled

Drug / intervention

Enhanced surgical iMedConsent process (with "repeat back") +1 moreother

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00288899

NCT00288899Phase 1Completed

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

VA Office of Research and Development·interventional·Posted Feb 8, 2006·Updated Jun 6, 2017

In Brief

A Phase 1 clinical trial evaluating Enhanced surgical iMedConsent process (with "repeat back") and standard surgical iMedConsent process for Surgery and 4 related conditions. Completed, enrolled 575 participants across 7 sites.

Detailed 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".

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsSurgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip, Endarterectomy, Carotid

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

First PostedFeb 2006

Enrollment StartAug 2006

Primary CompletionMar 2009

TodayJul 2026

First PostedFeb 8, 2006

Enrollment StartAug 7, 2006

Primary CompletionMar 31, 2009

TodayJul 2, 2026

Enrollment to primary: 2.6 yearsPosted 20.4 years ago

Interventions

Enhanced surgical iMedConsent process (with "repeat back")other

Consent process engages patient in discussion about why they are having procedure, risks, benefits, alternatives. Then provider asks patient to "repeat back"what they understand.

standard surgical iMedConsent processother

Patients are consented in standard VA consent process, where are not necessarily asked to repeat back and no discussion is necessarily documented.