The goals of this research study are the following: 1. To compare the effects of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy for total knee replacement (TKR) on 90-day health service use costs. 2. To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes 3. To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.
This study will compare the effects on health service use costs of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy following total knee replacement (TKR) surgery. It will also examine standard post-surgical clinical measures to confirm non-inferiority of outcomes between groups. A total of 300 patients will receive standard pre- and post-surgical medical care from their healthcare providers, and be randomized to receive pre-surgery rehabilitation exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based physical therapy regimen (control group, n=150). Data will be collected by sites at enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and 3 months after surgery. Patients will also keep a diary from hospital discharge through 3 months documenting healthcare utilization and progress toward a personal recovery goal. Diary information will be collected over the phone concurrently with administration of the 6-week and 3-month surveys. The episode for analysis will be from surgery through 3 months post-discharge, in alignment with the Centers for Medicare and Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or benefits to patients for participating in this study are as expected from standard pre- and post-surgical physical therapy associated with total knee replacement surgery. The low risk of loss of confidentiality for all subjects will be minimized using appropriate safeguards.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
306
Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
Traditional physical therapy delivered in clinic or via home-health visits
University of North Carolina Orhthopedics
Chapel Hill, North Carolina, United States
Duke Orthopaedics
Durham, North Carolina, United States
Greensboro Orthopedics
Greensboro, North Carolina, United States
Raleigh Orthopaedics
Raleigh, North Carolina, United States
Cost Difference in US Dollars
Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.
Time frame: 12 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Survey regarding health \[Knee Injury and Osteoarthritis Outcome Score (KOOS)\] for pain, symptoms, activities of daily living, function in sports and recreation, and knee-related quality of life (QOL) at 6 weeks and 12 weeks, scored from 0 to 100. Higher score indicates better outcomes.
Time frame: 6 weeks and 12 weeks
Range of Motion
Knee range of motion \[lower (extension) and upper range of motion (flexion)\] at 6 weeks
Time frame: 6 weeks
10-meter Gait Speed
Gait speed 6 weeks after surgery
Time frame: 6 weeks
Pain Score
Non-inferiority safety endpoint: pain score at 12 weeks. Measured on scale from 0 to 10, with 0 being no pain and 10 being worst pain imaginable.
Time frame: 12 weeks
Report of Falls
Any fall reported between hospital discharge and 12-week follow-up (yes/no)
Time frame: 12 weeks
Re-hospitalization
Re-hospitalizations since hospital discharge (total count)
Time frame: 12 weeks
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