Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Completed · Phase 1
Conditions studied: Surgery, Cholecystectomy, Laparoscopic, Prostatectomy, Arthroplasty, Replacement, Hip, Endarterectomy, Carotid
In brief
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".
Key facts
- Study ID
- NCT00288899
- Run by
- VA Office of Research and Development
- People needed
- 575
- Starts
- 2006-08-07
- Expected to finish
- 2009-03-31
- Last updated by the study team
- 2017-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veterans who are scheduled for one of the four elective surgical procedures;
- who give informed consent to participate in the study;
- and who are also part of the NSQIP.
You may not qualify if…
- Inability to give informed consent;
- requirement for surrogate consent;
- non-elective surgery;
- requirement for more than one elective surgery;
- refusal to participate;
- inability to communicate in English;
- severe visual problems;
- severe psychiatric illness;
- ongoing substance abuse.
Where it is running
- VA Eastern Colorado Health Care System, Denver, CO — Denver, Colorado, United States
- James A. Haley Veterans' Hospital, Tampa, FL — Tampa, Florida, United States
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
- VA Portland Health Care System, Portland, OR — Portland, Oregon, United States
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
- Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States
Full record on ClinicalTrials.gov
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