Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories
2 other identifiers
observational
200
1 country
2
Brief Summary
This study will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. The investigators clinical support decision tool is designed to help physical therapists tailor rehabilitation treatments and dosages to the individual needs, goals, and preferences of Veterans recovering from TKA. This study has the potential to improve Veterans' functional recovery after TKA, while simultaneously reducing the average number of physical therapy visits Veterans attend after surgery by tailoring rehabilitation dosage based upon need. This will ensure the Veterans Health Administration (VHA) has the resources and capacity to provide adequate rehabilitation to every Veteran seeking TKA in the VHA system. Additionally, if successful, this clinical decision support tool could be used to improve outcomes and access for additional patient populations in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
March 21, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 25, 2026
March 1, 2026
4.5 years
March 10, 2022
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Knee Injury and Osteoarthritis Outcome - Joint Replacement (KOOS, JR)
The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness. KOOS JR will be assessed preoperatively at baseline and re-assessed at 90 (primary timepoint) and 180 days after TKA surgery. KOOS JR will also be assessed postoperatively throughout participants' rehabilitation episode at approximately 2-week intervals up to 180 days after surgery. We will use the interval scoring method for the KOOS JR which ranges from 0 (total knee disability) to 100 (perfect knee health)
Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)
Outpatient Physical Therapy Visit Utilization
The total outpatient physical therapy visits used in the first 90 postoperative days by each Veteran participant will be extracted from the electronic health record after the Veteran is formally discharged from outpatient rehabilitation. Any visits that occur prior to a Veteran's surgery or in the hospital setting will not count toward the total visit number. We chose postoperative day 90 as our primary endpoint because it corresponds with the average discharge timeframe for outpatient rehabilitation after total knee arthroplasty. Visit utilization will also be assed at at 30, 60, and 180 days after TKA surgery.
Postoperative day 90
Secondary Outcomes (4)
Lower Extremity Functional Scale (LEFS)
Collected preoperatively at baseline with follow up assessments at 90 and 180 days after TKA surgery
Timed Up and Go (TUG)
Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Knee range of motion (ROM)
Collected preoperatively at baseline and postoperatively at approximately 2-week intervals up to 180 days after TKA surgery
Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery
Other Outcomes (1)
Veterans Rand 12-item Health Survey (VR-12)
Collected preoperatively at baseline with one follow up assessment at 90 days after TKA surgery
Study Arms (2)
Control cohort
The investigators will collect outcomes for 100 Veterans treated with usual care rehabilitation after total knee arthroplasty. Data will be collected at all participating clinical locations. Data collection for these Veterans will precede data collection for the intervention cohort.
Intervention cohort
The investigators will implement the clinical decision support tool in all participating clinic locations. We will collect outcomes for 100 Veterans treated in rehabilitation with use of the clinical decision support tool. Data collection for these Veterans will occur after data collection is complete for the Control cohort.
Interventions
The investigators will integrate the CDS tool into clinical practice at each participating clinic after data collection for the Control cohort is complete. All physical therapists at the participating clinic locations will use the CDS tool to inform rehabilitation decision making for Veterans with total knee arthroplasty. The CDS tool will provide personalized information regarding each Veterans' recovery in addition to personalized visit utilization guidelines. Clinicians will use the CDS tool with Veterans at their initial postoperative visits and every 2weeks throughout their course of care thereafter.
Eligibility Criteria
Veterans with total knee replacement who seek postoperative outpatient physical therapy treatment at the participating clinics.
You may qualify if:
- Veterans who have undergone total knee arthroplasty who present for outpatient rehabilitation treatment at the participating clinics within three weeks of surgery.
You may not qualify if:
- postoperative rehabilitation treatment received in the home health or skilled nursing
- age \< 40 or \>90
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer E. Stevens-Lapsley, PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2022
First Posted
March 21, 2022
Study Start
April 1, 2022
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available after the main study results are published.
- Access Criteria
- Data will be available after the main study results are published for up to 5 years.
The research team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. All data released will be de-identified, with no information that could be linked to any study participants (patients and clinicians), or participating study practices to ensure the confidentiality of all participants and practices. If necessary, a data use agreement will be established.