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

The aim of the study is determine which method of informed consent improves comprehension in college educated patients in a private practice setting.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Truman Medical Center and Dickson-Diveley Orthopaedic Clinic

Kansas City, Missouri, 64108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Model

Behavioral

Each participant will receive an informed consent discussion with the aid of an anatomic knee model.

Knee Anatomy Video

Behavioral

Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.

Verbal

Behavioral

Each participant will receive a verbal informed consent discussion without a visual aid.

Primary outcomes

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".

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2016
First posted: Feb 29, 2016
Registry last updated: May 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed