Shared Decision Making and How It Impacts the Patient Understanding

• Sponsor: Hospital for Special Surgery, New York (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04011488
• Collaborator: University of Pennsylvania (Other), Johns Hopkins University (Other), 3rd Coast Research Associates (Other), Yale University (Other), University Hospitals Cleveland Medical Center (Other), PIH Family Practice Residency (Other), Baylor College of Medicine (Other), Zimmer Biomet (Industry)
• Enrollment: 108
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.9
• Patients Per Site Per Month: 2.9

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2016
• Actual Primary Completion Date: Jun 30, 2019
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Patient Information Survey [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), [One month post intervention]

   Depression Survey

2. Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR) [One month post intervention]

   joint specific functional outcome survey

3. Patient Experience Survey [One month post intervention]

4. Patient Information Survey- Qualitative portion [One month post intervention]

5. Shared Decision Making (SDM) Survey [One month post intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 64 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

• Principal Investigator: Michael L Parks, MD, Hospital for Special Surgery, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT04011488
• Other Study ID Numbers: 2016-462
• First Posted: Jul 8, 2019
• Last Update Posted: Jul 8, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 8, 2019