Shared Decision Making and How It Impacts the Patient Understanding

Not Applicable

Terminated

• Conditions: Knee Osteoarthritis
• Interventions: Other: Shared Decision Making Tool

• Registration Number: NCT04011488
• Lead Sponsor: 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?

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-05
• Last Update Submitted: 2019-07-05
• Study First Posted: 2019-07-08
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SDM Tool	Shared Decision Making 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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Personal Health Questionnaire (PHQ-8),	One month post intervention	Depression Survey
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)	One month post intervention	joint specific functional outcome survey
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

Trial Locations

Locations (1)

Michael L. Parks, MD; 🇺🇸 New York, New York, United States