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The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent

NCT02416505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2016-10-04

No results posted yet for this study

Summary

This study is a Non-funded, Single Center, Multi-Arm, Parallel Group Randomize Control Trial.

In this study, the investigators aim to evaluate the impact of a visual aid on patient comprehension an orthopedic informed consent discussion in low socioeconomic populations.

The primary outcome is patient comprehension measured by a Validated Knowledge-Based Multiple Choice Questionnaire.

The secondary outcomes include: Patient satisfaction and Time efficiency.

The investigators hypothesize that using an Anatomic Model Visual Aid during an orthopedic informed consent discussion will improve patient comprehension, satisfaction and time-efficiency of orthopedic care.

Conditions

Interventions

BEHAVIORAL

Verbal+Anatomic Model

BEHAVIORAL

Verbal+Video

Sponsors & Collaborators

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Mark Bernhardt, MD · UMKC Department of Orthopaedic Surgery

  • Johnathan Dubin, MD · UMKC Department of Orthopaedic Surgery

  • Karen Williams, PhD · UMKC Dept of Bioinformatics

  • Nkem Egekeze, MD · UMKC Dept of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02416505 on ClinicalTrials.gov