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Shared Decision Making and How It Impacts the Patient Understanding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04011488
Recruitment Status : Terminated (Low patient recruitment)
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
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
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

  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?

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Shared Decision Making Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.





Primary Outcome Measures :
  1. Patient Information Survey [ Time Frame: One month afterwards ]
    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 :
  1. Personal Health Questionnaire (PHQ-8), [ Time Frame: One month post intervention ]
    Depression Survey

  2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR) [ Time Frame: One month post intervention ]
    joint specific functional outcome survey

  3. Patient Experience Survey [ Time Frame: One month post intervention ]
  4. Patient Information Survey- Qualitative portion [ Time Frame: One month post intervention ]
  5. Shared Decision Making (SDM) Survey [ Time Frame: One month post intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011488


Locations
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United States, New York
Michael L. Parks, MD
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
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
Investigators
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Principal Investigator: Michael L Parks, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04011488     History of Changes
Other Study ID Numbers: 2016-462
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital for Special Surgery, New York:
shared decision making

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases