Shared Decision Making and How It Impacts the Patient Understanding

Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol

Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis.

1. Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women?
2. Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
3. What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Shared Decision Making Tool

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Michael L. Parks, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• - Aged 45 to 64 years
• Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician
• Self-identified as African American and/or Hispanic

• At least one of the following comorbidities:

  1. Obesity (BMI ≥ 30),
  2. Hypertension (ICD10 codes below)
  3. Diabetes (ICD10 codes below)

Exclusion Criteria:

• - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
• Prior total knee replacement
• Recommended total knee replacement
• Acute knee trauma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard patient information data sheet
Experimental: SDM Tool; A simple, one-page tool that provides a framework for the patient discussion, which improves the consistency of the patient-provider communication. This SDM can also be customized to a specific patient based on gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).	Other: Shared Decision Making Tool; We've used the framework from this model and adapted it to the patient perspective to create a Patient Shared Decision Making Tool. The model is interactive so it can be customized to a specific patient. It has adjustments built in for gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes). The strongest, underlying message is that any treatment choice is better than not seeking treatment. To illustrate this, a "Do Nothing" pathway is included for comparison purposes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Information Survey	The primary outcome instrument is the Patient Information Survey administered shortly after the evaluation. There is both a qualitative and quantitative portion of the survey.	One month afterwards

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Health Questionnaire (PHQ-8),	Depression Survey	One month post intervention
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)	joint specific functional outcome survey	One month post intervention
Patient Experience Survey		One month post intervention
Patient Information Survey- Qualitative portion		One month post intervention
Shared Decision Making (SDM) Survey		One month post intervention

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Johns Hopkins University; Baylor College of Medicine; University of Pennsylvania; Yale University; Zimmer Biomet; University Hospitals Cleveland Medical Center; 3rd Coast Research Associates; PIH Family Practice Residency
• Investigators: Principal Investigator: Michael L Parks, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 2, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 5, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: shared decision making
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2016-462

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No