Shared Decision Making and How It Impacts the Patient Understanding

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04011488
• Other study ID #: 2016-462
• Status: Terminated
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Michael L. Parks, MD	New York	New York

Sponsors (9)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	3rd Coast Research Associates, Baylor College of Medicine, Johns Hopkins University, PIH Family Practice Residency, University Hospitals Cleveland Medical Center, University of Pennsylvania, Yale University, Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

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