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

Hospital for Special Surgery, New York1 site in 1 country108 target enrollmentJune 2016

ConditionsKnee Osteoarthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Hospital for Special Surgery, New York
Enrollment: 108
Locations: 1
Primary Endpoint: Patient Information Survey
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

June 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hospital for Special Surgery, New York

Responsible Party

Sponsor

Eligibility 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:
•Obesity (BMI ≥ 30),
•Hypertension (ICD10 codes below)
•Diabetes (ICD10 codes below)

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

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)