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

University of Missouri, Kansas City

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Behavioral: Verbal+Video; Behavioral: Verbal+Anatomic Model

Study type: Interventional

Funder types: Other

Identifiers

NCT02416505

14-334

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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67 participants in 3 patient groups

Verbal Discussion: Control Group

No Intervention group

Description:

In this group, participants will receive a 10 minute Verbal Only Knee Osteoarthritis Steroid Injection Informed Consent discussion. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.

Verbal+Anatomic Model

Active Comparator group

Description:

This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Knee Model. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.

Treatment:

Behavioral: Verbal+Anatomic Model

Verbal+Video Presentation

Active Comparator group

Description:

This intervention group will receive a 10 minute Knee Osteoarthritis Steroid Injection Informed Consent discussion with the aid of a Video. This discussion will cover the relevant topics of Knee OA causes, relevant anatomy, symptoms, diagnosis, and treatment options. This discussion will also include the risks, benefits, and alternatives to a steroid injection.

Treatment:

Behavioral: Verbal+Video