Shared Decision Making and How It Impacts the Patient Understanding
NCT ID: NCT04011488
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
108 participants
INTERVENTIONAL
2016-06-30
2019-06-30
Brief Summary
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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?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Standard patient information data sheet
No interventions assigned to this group
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior total knee replacement
* Recommended total knee replacement
* Acute knee trauma
45 Years
64 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Johns Hopkins University
OTHER
3rd Coast Research Associates
UNKNOWN
Yale University
OTHER
University Hospitals Cleveland Medical Center
OTHER
PIH Family Practice Residency
UNKNOWN
Baylor College of Medicine
OTHER
Zimmer Biomet
INDUSTRY
Hospital for Special Surgery, New York
OTHER
Responsible Party
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Principal Investigators
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Michael L Parks, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Locations
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Michael L. Parks, MD
New York, New York, United States
Countries
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Other Identifiers
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2016-462
Identifier Type: -
Identifier Source: org_study_id
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