Shared Decision Making and How It Impacts the Patient Understanding
Primary Purpose
Knee Osteoarthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision Making Tool
Sponsored by
About this trial
This is an interventional other trial for Knee Osteoarthritis focused on measuring shared decision making
Eligibility Criteria
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:
- Obesity (BMI ≥ 30),
- Hypertension (ICD10 codes below)
- Diabetes (ICD10 codes below)
Exclusion Criteria:
- - Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
- Prior total knee replacement
- Recommended total knee replacement
- Acute knee trauma
Sites / Locations
- Michael L. Parks, MD
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard patient information data sheet
SDM Tool
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Personal Health Questionnaire (PHQ-8),
Depression Survey
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
joint specific functional outcome survey
Patient Experience Survey
Patient Information Survey- Qualitative portion
Shared Decision Making (SDM) Survey
Full Information
NCT ID
NCT04011488
First Posted
July 2, 2019
Last Updated
July 5, 2019
Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Pennsylvania, Johns Hopkins University, 3rd Coast Research Associates, Yale University, University Hospitals Cleveland Medical Center, PIH Family Practice Residency, Baylor College of Medicine, Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT04011488
Brief Title
Shared Decision Making and How It Impacts the Patient Understanding
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Low patient recruitment
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
University of Pennsylvania, Johns Hopkins University, 3rd Coast Research Associates, Yale University, University Hospitals Cleveland Medical Center, PIH Family Practice Residency, Baylor College of Medicine, Zimmer Biomet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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?
Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
shared decision making
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard patient information data sheet
Arm Type
No Intervention
Arm Title
SDM Tool
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Shared Decision Making Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Information Survey
Description
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.
Time Frame
One month afterwards
Secondary Outcome Measure Information:
Title
Personal Health Questionnaire (PHQ-8),
Description
Depression Survey
Time Frame
One month post intervention
Title
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)
Description
joint specific functional outcome survey
Time Frame
One month post intervention
Title
Patient Experience Survey
Time Frame
One month post intervention
Title
Patient Information Survey- Qualitative portion
Time Frame
One month post intervention
Title
Shared Decision Making (SDM) Survey
Time Frame
One month post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Obesity (BMI ≥ 30),
Hypertension (ICD10 codes below)
Diabetes (ICD10 codes below)
Exclusion Criteria:
- Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
Prior total knee replacement
Recommended total knee replacement
Acute knee trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Parks, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael L. Parks, MD
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Shared Decision Making and How It Impacts the Patient Understanding
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