The Age of OrthoInfo: A Randomized Controlled Trial Evaluating Patient Comprehension of Informed Consent in a Private Practice

April 28, 2016 updated by: Nkemakolam Egekeze, University of Missouri, Kansas City
The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Truman Medical Center and Dickson-Diveley Orthopaedic Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.

Exclusion Criteria:

  • Patients without the capacity to provide consent
  • Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Verbal
This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.
Behavioral: Verbal
Each participant will receive a verbal informed consent discussion without a visual aid.
Active Comparator: Verbal + Model
This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.
Behavioral: Model
Each participant will receive an informed consent discussion with the aid of an anatomic knee model.
Active Comparator: Verbal + Video
This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer.
Behavioral: Knee Anatomy Video
Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Nkem Test
Time Frame: baseline
This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri, Kansas City

Investigators

  • Principal Investigator: Nkem Egekeze, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Charles Rhoades, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Karen Williams, PhD, UMKC Department of Health Insight and Research
  • Study Director: Luv Singh, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Dan Gurba, MD, Dickson-Diveley Orthopaedic Clinic
  • Study Chair: Mark Bernhardt, MD, UMKC DEPT OF ORTHOPAEDIC SURGERY

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 18, 2016

First Submitted That Met QC Criteria

February 26, 2016

First Posted (Estimate)

February 29, 2016

Study Record Updates

Last Update Posted (Estimate)

May 2, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoInfo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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