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

October 2, 2016 updated by: Nkemakolam Egekeze, University of Missouri, Kansas City

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

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:

  • Patients newly diagnosed with Knee Osteoarthritis managed with steroid injections
  • Patients who express lack of knowledge regarding knee osteoarthritis (causes, diagnosis, treatment, anatomy)
  • English speaking
  • Patients that meet the Federal Poverty Guideline for Healthcare (i.e. Medicaid)

Exclusion Criteria:

  • Patients under the age of 18
  • College graduates
  • Non-English speaking
  • Patient without the capacity to give consent
  • Patients with a tactile, mental, visual or auditory disability

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Verbal Discussion: Control Group

In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion.

This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
Active Comparator: Verbal+Anatomic Model

This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model.

This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
Behavioral: Verbal+Anatomic Model
Active Comparator: Verbal+Video Presentation

This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video.

This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.
Behavioral: Verbal+Video

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Nkem Test
Time Frame: 20 minutes
Comprehension based examination of an informed consent discussion
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Satisfaction Survey
Time Frame: 5 minutes
5 minutes

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 DEPT OF ORTHOPAEDIC SURGERY
  • Study Director: Karen Williams, PhD, UMKC DEPT OF BIOINFORMATICS
  • Study Chair: Mark Bernhardt, MD, UMKC Department of Orthopaedic Surgery
  • Study Director: Johnathan Dubin, MD, UMKC Department 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

September 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 9, 2015

First Posted (Estimate)

April 15, 2015

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 2, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-334

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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