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

NCT02694237 | Completed

• 1 other identifier: OrthoInfo
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Nkem Test

  This knowledge based questionnaire assesses patient comprehension of an informed consent discussion. The score of the test is known as "The Nkem Score".

  baseline

Study Arms (3)

Verbal

ACTIVE COMPARATOR

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

Behavioral: Verbal

Verbal + Model

ACTIVE COMPARATOR

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

Behavioral: Model

Verbal + Video

ACTIVE COMPARATOR

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.

Behavioral: Knee Anatomy Video

Interventions

Model BEHAVIORAL

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

Verbal + Model

Knee Anatomy Video BEHAVIORAL

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

Verbal + Video

Verbal BEHAVIORAL

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

Verbal

Eligibility Criteria

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

You may qualify if:

• Knee osteoarthritis patients over the age of 18 with a college education deemed appropriate for medical management with a knee injection.

You may not qualify if:

• Patients without the capacity to provide consent
• Patients with a visual, auditory, psychological or tactile impairment requiring the assistance of another person.

Sponsors & Collaborators

• University of Missouri, Kansas City: lead

Study Sites (1)

Truman Medical Center and Dickson-Diveley Orthopaedic Clinic

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Models, Biological; Memory and Learning Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Nkem Egekeze, MD

  UMKC Department of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

• Karen Williams, PhD

  UMKC Department of Health Insight and Research

  STUDY DIRECTOR

• Luv Singh, MD

  UMKC Department of Orthopaedic Surgery

  STUDY DIRECTOR

• Dan Gurba, MD

  Dickson-Diveley Orthopaedic Clinic

  STUDY DIRECTOR

• Charles Rhoades, MD

  UMKC Department of Orthopaedic Surgery

  STUDY DIRECTOR

• Mark Bernhardt, MD

  UMKC Dept of Orthopaedic Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UMKC Orthopaedic Research Fellow

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04

Locations

US (1)