Virtual Exercise Rehabilitation In-home Therapy: A Randomized Study (VERITAS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Total Knee Replacement
- Sponsor
- Duke University
- Enrollment
- 306
- Locations
- 4
- Primary Endpoint
- Cost Difference in US Dollars
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The goals of this research study are the following:
- 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.
- To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
- To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •≥ 18 years of age
- •Scheduled to have a non-traumatic TKR
- •Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
- •Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization
Exclusion Criteria
- •Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
- •Scheduled for staged bilateral TKR
- •Living in a nursing home prior to surgery
Outcomes
Primary Outcomes
Cost Difference in US Dollars
Time Frame: 12 weeks
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.
Secondary Outcomes
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(6 weeks and 12 weeks)
- Range of Motion(6 weeks)
- Report of Falls(12 weeks)
- Re-hospitalization(12 weeks)
- 10-meter Gait Speed(6 weeks)
- Pain Score(12 weeks)