Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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please see details above

Official Title
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Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Other: video or education session in addition to standard consent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recommended total knee arthroplasty Exclusion Criteria: Unwilling to participate Unable to complete questionnaire in English
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: iMedConsentTM and customized written handout group<br>iMedConsentTM and a customized written handout | Other: video or education session in addition to standard consent<br>* Video added to standard consent + handout Video + education session added to standard consent + handout<br>|
| Experimental: iMedConsentTM, handout, and standard video g<br>iMedConsentTM, handout, and standard AAOS video | Other: video or education session in addition to standard consent<br>* Video added to standard consent + handout Video + education session added to standard consent + handout<br>|
| Experimental: iMedConsentTM, handout, video, and formal education<br>iMedConsentTM, the handout, the video, and a formal education session | Other: video or education session in addition to standard consent<br>* Video added to standard consent + handout Video + education session added to standard consent + handout<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge of efficacy and complications | answers to questionnaire assessing knowledge | 6-week postoperative | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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consent, Patient Understanding, Knee Arthroplasty