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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02416505
Enrollment
67
Registered
2015-04-15
Start date
2014-09-30
Completion date
Unknown
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief 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.

Interventions

BEHAVIORALVerbal+Anatomic Model
BEHAVIORALVerbal+Video

Sponsors

University of Missouri, Kansas City
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Nkem Test20 minutesComprehension based examination of an informed consent discussion

Secondary

MeasureTime frame
Patient Satisfaction Survey5 minutes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026