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

NCT02416505 | Completed

• 1 other identifier: 14-334
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Nkem Test

  Comprehension based examination of an informed consent discussion

  20 minutes

Secondary Outcomes (1)

• Patient Satisfaction Survey

  5 minutes

Study Arms (3)

Verbal Discussion: Control Group

NO INTERVENTION

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

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.

Behavioral: Verbal+Anatomic Model

Verbal+Video Presentation

ACTIVE COMPARATOR

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.

Behavioral: Verbal+Video

Interventions

Verbal+Anatomic Model BEHAVIORAL

Verbal+Anatomic Model

Verbal+Video BEHAVIORAL

Verbal+Video Presentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark Bernhardt, MD

  UMKC Department of Orthopaedic Surgery

  STUDY CHAIR

• Johnathan Dubin, MD

  UMKC Department of Orthopaedic Surgery

  STUDY DIRECTOR

• Karen Williams, PhD

  UMKC Dept of Bioinformatics

  STUDY DIRECTOR

• Nkem Egekeze, MD

  UMKC Dept of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgery Researcher

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 15, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: October 4, 2016

Record last verified: 2016-10