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Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582984
First Posted: April 23, 2012
Last Update Posted: April 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
jasvinder singh, Minneapolis Veterans Affairs Medical Center
  Purpose
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.

Condition Intervention
Knee Arthroplasty Other: video or education session in addition to standard consent

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by jasvinder singh, Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Knowledge of efficacy and complications [ Time Frame: 6-week postoperative ]
    answers to questionnaire assessing knowledge


Secondary Outcome Measures:
  • 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

  • knowledge regarding risks of surgery [ Time Frame: day of surgery and postoperative 6-weeks ]
    answers to Questions 7-9 on quetionnaire

  • Knowledge regarding peri- and post-operative results [ Time Frame: day of surgery and postoperative 6-weeks ]
    answers to Questions 10-13 on quetionnaire

  • Patient satisfaction [ Time Frame: day of surgery and postoperative 6-weeks ]
    answers to satisfaction Question on quetionnaire


Enrollment: 176
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:
please see details above
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. recommended total knee arthroplasty

Exclusion Criteria:

  1. Unwilling to participate
  2. Unable to complete questionnaire in English
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582984


Locations
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
jasvinder singh
Investigators
Principal Investigator: Terence Gioe, MD Minneapolis VA Med crt
  More Information

Responsible Party: jasvinder singh, worker without compensation, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01582984     History of Changes
Other Study ID Numbers: MSPVA-124
First Submitted: April 18, 2012
First Posted: April 23, 2012
Last Update Posted: April 24, 2012
Last Verified: April 2012

Keywords provided by jasvinder singh, Minneapolis Veterans Affairs Medical Center:
consent
Patient Understanding
Knee Arthroplasty