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Patient Understanding and Satisfaction in Informed Consent for Total Knee Arthroplasty

NCT ID: NCT01582984

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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please see details above

Conditions

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Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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iMedConsentTM and customized written handout group

iMedConsentTM and a customized written handout

Group Type ACTIVE_COMPARATOR

video or education session in addition to standard consent

Intervention Type OTHER

Video added to standard consent + handout Video + education session added to standard consent + handout

iMedConsentTM, handout, and standard video g

iMedConsentTM, handout, and standard AAOS video

Group Type EXPERIMENTAL

video or education session in addition to standard consent

Intervention Type OTHER

Video added to standard consent + handout Video + education session added to standard consent + handout

iMedConsentTM, handout, video, and formal education

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

Group Type EXPERIMENTAL

video or education session in addition to standard consent

Intervention Type OTHER

Video added to standard consent + handout Video + education session added to standard consent + handout

Interventions

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video or education session in addition to standard consent

Video added to standard consent + handout Video + education session added to standard consent + handout

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. recommended total knee arthroplasty

Exclusion Criteria

1. Unwilling to participate
2. Unable to complete questionnaire in English
Minimum Eligible Age

18 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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jasvinder singh

FED

Sponsor Role lead

Responsible Party

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jasvinder singh

worker without compensation

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Terence Gioe, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis VA Med crt

Locations

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Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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MSPVA-124

Identifier Type: -

Identifier Source: org_study_id

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