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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02694237

Enrollment

Registered

2016-02-29

Start date

2016-03-31

Completion date

Unknown

Last updated

2016-05-02

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

Conditions

Knee Osteoarthritis

Brief summary

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

Interventions

BEHAVIORALModel

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

BEHAVIORALKnee Anatomy Video

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

BEHAVIORALVerbal

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The Nkem Test	baseline	This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as The Nkem Score.

Countries

United States

Outcome results

None listed

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