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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416505
• Other study ID #: 14-334
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: October 2, 2016
• Start date: September 2014

Study information

• Verified date: October 2016
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Verbal+Anatomic Model

• Verbal+Video

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri, Kansas City

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Nkem Test	Comprehension based examination of an informed consent discussion	20 minutes	No
Secondary	Patient Satisfaction Survey		5 minutes	No