Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Knee Arthroplasty Clinical Trial

Official title:

Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582984
• Other study ID #: MSPVA-124
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: March 2024
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

please see details above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

1. recommended total knee arthroplasty

Exclusion Criteria:

1. Unwilling to participate

2. Unable to complete questionnaire in English

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Other:
• video or education session in addition to standard consent
Video added to standard consent + handout Video + education session added to standard consent + handout

Locations

Country	Name	City	State
United States	Minneapolis VA Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
jasvinder singh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of efficacy and complications	answers to questionnaire assessing knowledge	6-week postoperative
Secondary	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
Secondary	knowledge regarding risks of surgery	answers to Questions 7-9 on quetionnaire	day of surgery and postoperative 6-weeks
Secondary	Knowledge regarding peri- and post-operative results	answers to Questions 10-13 on quetionnaire	day of surgery and postoperative 6-weeks
Secondary	Patient satisfaction	answers to satisfaction Question on quetionnaire	day of surgery and postoperative 6-weeks