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

NCT00288899 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2017-06-06

No results posted yet for this 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".

Conditions

  • Surgery
  • Cholecystectomy, Laparoscopic
  • Prostatectomy
  • Arthroplasty, Replacement, Hip
  • Endarterectomy, Carotid

Interventions

OTHER

Enhanced surgical iMedConsent process (with "repeat back")

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.

OTHER

standard surgical iMedConsent process

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

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Aaron S Fink, MD · Atlanta VA Medical and Rehab Center, Decatur, GA

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-07
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00288899 on ClinicalTrials.gov