Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Other: video or education session in addition to standard consent

• Registration Number: NCT01582984
• Lead Sponsor: jasvinder singh

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 Timeline

• Study Start: 2008-02
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2012-04-18
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

1. recommended total knee arthroplasty

Exclusion Criteria

1. Unwilling to participate
2. Unable to complete questionnaire in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iMedConsentTM, handout, and standard video g	video or education session in addition to standard consent	iMedConsentTM, handout, and standard AAOS video
iMedConsentTM, handout, video, and formal education	video or education session in addition to standard consent	iMedConsentTM, the handout, the video, and a formal education session
iMedConsentTM and customized written handout group	video or education session in addition to standard consent	iMedConsentTM and a customized written handout

Primary Outcome Measures

Name	Time	Method
Knowledge of efficacy and complications	6-week postoperative	answers to questionnaire assessing knowledge

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	day of surgery and postoperative 6-weeks	answers to satisfaction Question on quetionnaire
Knowledge regarding peri- and post-operative results	day of surgery and postoperative 6-weeks	answers to Questions 10-13 on quetionnaire
knowledge regarding procedural questions with regard to the surgery and implants	Day of surgery and 6-week postoperative	Answers to Question 4-6 on knowledge questionnaire
knowledge regarding risks of surgery	day of surgery and postoperative 6-weeks	answers to Questions 7-9 on quetionnaire

Trial Locations

Locations (1)

Minneapolis VA Medical Center; 🇺🇸 Minneapolis, Minnesota, United States