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Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
jasvinder singh, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT01582984
First received: April 18, 2012
Last updated: April 21, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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

Primary Outcome Measures:
  • Knowledge of efficacy and complications [ Time Frame: 6-week postoperative ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Answers to Question 4-6 on knowledge questionnaire

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

  • Knowledge regarding peri- and post-operative results [ Time Frame: day of surgery and postoperative 6-weeks ] [ Designated as safety issue: No ]
    answers to Questions 10-13 on quetionnaire

  • Patient satisfaction [ Time Frame: day of surgery and postoperative 6-weeks ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 18, 2012
Last Updated: April 21, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 16, 2013