Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
1 other identifier
interventional
176
1 country
1
Brief Summary
A structured consent process, in combination with one or a number of the aforementioned modalities (nursing education, handout, video, etc), may reasonably be expected to improve surgical informed consent. The investigators hypothesized that overall patient knowledge/retention would be influenced by the type of consent process and that more intensive training and review would result in better patient retention and recall. The investigators further hypothesized that the knowledge retention would decline following the consent process and surgery, but in a stratified manner based on the nature of preoperative teaching.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 18, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedMarch 13, 2024
March 1, 2024
1.5 years
April 18, 2012
March 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge of efficacy and complications
answers to questionnaire assessing knowledge
6-week postoperative
Secondary Outcomes (4)
knowledge regarding procedural questions with regard to the surgery and implants
Day of surgery and 6-week postoperative
knowledge regarding risks of surgery
day of surgery and postoperative 6-weeks
Knowledge regarding peri- and post-operative results
day of surgery and postoperative 6-weeks
Patient satisfaction
day of surgery and postoperative 6-weeks
Study Arms (3)
iMedConsentTM and customized written handout group
ACTIVE COMPARATORiMedConsentTM and a customized written handout
iMedConsentTM, handout, and standard video g
EXPERIMENTALiMedConsentTM, handout, and standard AAOS video
iMedConsentTM, handout, video, and formal education
EXPERIMENTALiMedConsentTM, the handout, the video, and a formal education session
Interventions
Video added to standard consent + handout Video + education session added to standard consent + handout
Eligibility Criteria
You may qualify if:
- recommended total knee arthroplasty
You may not qualify if:
- Unwilling to participate
- Unable to complete questionnaire in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- jasvinder singhlead
Study Sites (1)
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terence Gioe, MD
Minneapolis VA Med crt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- worker without compensation
Study Record Dates
First Submitted
April 18, 2012
First Posted
April 23, 2012
Study Start
February 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
March 13, 2024
Record last verified: 2024-03