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Shared Decision Making and How It Impacts the Patient Understanding

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04011488
Enrollment
108
Registered
2019-07-08
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

shared decision making

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?

Interventions

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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
3rd Coast Research Associates
CollaboratorUNKNOWN
Yale University
CollaboratorOTHER
University Hospitals Cleveland Medical Center
CollaboratorOTHER
PIH Family Practice Residency
CollaboratorUNKNOWN
Baylor College of Medicine
CollaboratorOTHER
Zimmer Biomet
CollaboratorINDUSTRY
Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 64 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Patient Information SurveyOne month afterwardsThe 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

MeasureTime frameDescription
Personal Health Questionnaire (PHQ-8),One month post interventionDepression Survey
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS,JR)One month post interventionjoint specific functional outcome survey
Patient Experience SurveyOne month post intervention
Patient Information Survey- Qualitative portionOne month post intervention
Shared Decision Making (SDM) SurveyOne month post intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026