Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- jasvinder singh
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Knowledge of efficacy and complications
Study Overview
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.
Detailed Description
please see details above
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •recommended total knee arthroplasty
Exclusion Criteria
- •Unwilling to participate
- •Unable to complete questionnaire in English
Arms & Interventions
iMedConsentTM and customized written handout group
iMedConsentTM and a customized written handout
Intervention: video or education session in addition to standard consent (Other)
iMedConsentTM, handout, and standard video g
iMedConsentTM, handout, and standard AAOS video
Intervention: video or education session in addition to standard consent (Other)
iMedConsentTM, handout, video, and formal education
iMedConsentTM, the handout, the video, and a formal education session
Intervention: video or education session in addition to standard consent (Other)
Outcomes
Primary Outcomes
Knowledge of efficacy and complications
Time Frame: 6-week postoperative
answers to questionnaire assessing knowledge
Secondary Outcomes
- Patient satisfaction(day of surgery and postoperative 6-weeks)
- Knowledge regarding peri- and post-operative results(day of surgery and postoperative 6-weeks)
- 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)
Investigators
jasvinder singh
worker without compensation
Minneapolis Veterans Affairs Medical Center