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

University of Missouri, Kansas City

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Knee Anatomy Video; Behavioral: Model; Behavioral: Verbal

Study type: Interventional

Funder types: Other

Identifiers

NCT02694237

OrthoInfo

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups

Verbal

Active Comparator group

Description:

This group will only receive a verbal discussion based on the same script used for all three groups. This is the control group.

Treatment:

Behavioral: Verbal

Verbal + Model

Active Comparator group

Description:

This group will receive a verbal discussion aided with an anatomic model intervention that group participants will be able to touch throughout the discussion.

Treatment:

Behavioral: Model

Verbal + Video

Active Comparator group

Description:

This group will receive a verbal discussion aided with a knee anatomy video intervention that will be played on silent an orated by an interviewer.

Treatment:

Behavioral: Knee Anatomy Video