Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

jasvinder singh

Status: Completed

Conditions: Knee Arthroplasty

Treatments: Other: video or education session in addition to standard consent

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01582984

MSPVA-124

Details and patient eligibility

About

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.

Full description

please see details above

Enrollment: 176 patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. recommended total knee arthroplasty

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 3 patient groups

iMedConsentTM and customized written handout group

Active Comparator group

Description:

iMedConsentTM and a customized written handout

Treatment:

Other: video or education session in addition to standard consent

iMedConsentTM, handout, and standard video g

Experimental group

Description:

iMedConsentTM, handout, and standard AAOS video

Treatment:

Other: video or education session in addition to standard consent

iMedConsentTM, handout, video, and formal education

Experimental group

Description:

iMedConsentTM, the handout, the video, and a formal education session

Treatment:

Other: video or education session in addition to standard consent