Status:
COMPLETED
Benefits of 'Repeat Back' Protocols Within A Computer-Based Informed Consent Program
Lead Sponsor:
VA Office of Research and Development
Conditions:
Surgery
Cholecystectomy, Laparoscopic
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 surgi...
Detailed Description
Background: Informed consent for surgical procedures is critical to patient care in the VA and in other health care settings. Many studies document limitations in current methods of obtaining informed...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT00288899
Start Date
August 7 2006
End Date
March 31 2009
Last Update
June 6 2017
Active Locations (7)
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1
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
2
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
3
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033
4
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130