Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

March 11, 2024 updated by: jasvinder singh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

please see details above

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. recommended total knee arthroplasty

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of efficacy and complications
Time Frame: 6-week postoperative
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
Time Frame: Day of surgery and 6-week postoperative
Answers to Question 4-6 on knowledge questionnaire
Day of surgery and 6-week postoperative
knowledge regarding risks of surgery
Time Frame: day of surgery and postoperative 6-weeks
answers to Questions 7-9 on quetionnaire
day of surgery and postoperative 6-weeks
Knowledge regarding peri- and post-operative results
Time Frame: day of surgery and postoperative 6-weeks
answers to Questions 10-13 on quetionnaire
day of surgery and postoperative 6-weeks
Patient satisfaction
Time Frame: day of surgery and postoperative 6-weeks
answers to satisfaction Question on quetionnaire
day of surgery and postoperative 6-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

jasvinder singh

Investigators

  • Principal Investigator: Terence Gioe, MD, Minneapolis VA Med crt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

April 18, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimated)

April 23, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MSPVA-124

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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