Shared Decision Making and How It Impacts the Patient Understanding

NCT04011488 | Terminated

• 1 other identifier: 2016-462
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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. 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. 2.Did use of the MIL SMD tool increase subject likeliness to recommend the physician?
3. 3.What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?

Conditions

Knee Osteoarthritis

Keywords

shared decision making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Personal Health Questionnaire (PHQ-8),

  One month post intervention

• Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)

  One month post intervention

• Patient Experience Survey

  One month post intervention

• Patient Information Survey- Qualitative portion

  One month post intervention

• Shared Decision Making (SDM) Survey

  One month post intervention

Study Arms (2)

Standard patient information data sheet

NO INTERVENTION

SDM Tool

EXPERIMENTAL

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

Interventions

Shared Decision Making Tool OTHER

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.

SDM Tool

Eligibility Criteria

• Age: 45 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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)

You may not qualify if:

• \- Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis)
• Prior total knee replacement
• Recommended total knee replacement
• Acute knee trauma

Sponsors & Collaborators

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

Study Sites (1)

Michael L. Parks, MD

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Michael L Parks, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 8, 2019
• Study Start: June 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)