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

University of Missouri, Kansas City66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Knee Osteoarthritis

Interventions

ModelBEHAVIORAL

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

Knee Anatomy VideoBEHAVIORAL

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

VerbalBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Truman Medical Center and Dickson-Diveley Orthopaedic Clinic

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

The Nkem Test

This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".

Time frame: baseline

Data from ClinicalTrials.gov

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