Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

Duke University

Status: Completed

Conditions: Total Knee Replacement

Treatments: Other: No intervention; Device: Virtual physical therapy rehabilitation program

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02914210

Pro00074409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age
2. Scheduled to have a non-traumatic TKR
3. Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
4. Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

Exclusion criteria

1. Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
2. Scheduled for staged bilateral TKR
3. Living in a nursing home prior to surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Virtual physical therapy

Other group

Description:

Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists

Treatment:

Device: Virtual physical therapy rehabilitation program

Traditional physical therapy

Other group

Description:

No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.

Treatment:

Other: No intervention