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

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.

Completed

Looking for future studies?

Notify Me

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Verbal+Anatomic Model

Behavioral

Verbal+Video

Behavioral

Primary outcomes

The Nkem Test

Time frame: 20 minutes

Comprehension based examination of an informed consent discussion

Secondary outcomes

Patient Satisfaction Survey

Time frame: 5 minutes

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
First posted: Apr 15, 2015
Registry last updated: Oct 4, 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