Clinical trial NCT05288803: Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories
Official title: Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Total Knee Arthroplasty
Keywords: total knee arthroplasty
patient-centered care
precision medicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans with total knee replacement who seek postoperative outpatient physical therapy treatment at the participating clinics.

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.

Detailed description: Rehabilitation after total knee arthroplasty (TKA) is typically generic and inefficient; most patients receive the same contents and dosage of rehabilitation regardless of the patients individual needs, preferences, or expectations. This generic treatment paradigm will be unsustainable in the Veterans Health Administration (VHA) as the demand for TKA surgery and postoperative care increase exponentially in the near future. Without new strategies to improve the efficiency of TKA rehabilitation, organizations like the VHA will struggle to meet and pay for this surging demand, and Veterans may be denied timely access to the postoperative care they need for optimal recovery. The investigators have developed an innovative new clinical decision support (CDS) tool to optimize efficiency in TKA rehabilitation. Using the actual recovery data of similar historical patients, the tool can predict the recovery trajectory for new patients after TKA. This allows clinicians to (1) allocate rehabilitation resources based upon individual need, (2) identify Veterans at risk for suboptimal outcomes early after surgery, (3) tailor treatment strategies to Veterans' unique goals and clinical presentation, and (4) monitor Veterans' recovery relative to expected throughout postoperative rehabilitation. In this project, the investigators propose to expand the CDS tool's capabilities by establishing utilization guidelines based upon individual Veteran's predicted recovery (Aim 1). These guidelines will be established by expert consensus in a three round Delphi process. Subsequently, the investigators will test the CDS tool's impact on Veteran's functional recovery and rehabilitation utilization in four VHA outpatient physical therapy clinics using a pre-post design (Aim 2). The investigators will compare patient-reported function (Lower Extremity Functional Scale) and physical therapy visit utilization between cohorts of Veterans treated with and without the CDS tool. Additionally, the investigators will gather data from participating VHA clinicians and Veterans regarding the translation of the investigators tool into clinical practice to assess its readiness for dissemination throughout the VHA (Aim 3). This will include qualitative data from participant focus groups and quantitative process data regarding the tool's utilization. Ultimately, the investigators expect this study will serve as a template for expanding the investigators tool's capabilities into numerous VHA populations in rehabilitation and beyond.

Eligibility criteria: Inclusion Criteria:

-Veterans who have undergone total knee arthroplasty who present for outpatient rehabilitation treatment at the participating clinics within three weeks of surgery.

Exclusion Criteria:

* postoperative rehabilitation treatment received in the home health or skilled nursing
* age \< 40 or \>90

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome - Joint Replacement (KOOS, JR)
timeFrame: Change in KOOS Jr from preop (baseline) to postop (90 days after TKA surgery)
measure: Outpatient Physical Therapy Visit Utilization
timeFrame: Postoperative day 90
Secondary outcomes:
measure: Lower Extremity Functional Scale (LEFS)
timeFrame: Change in LEFS from preop (baseline) to postop (90 days after TKA surgery).
measure: Timed Up and Go (TUG)
timeFrame: Change in TUG from preop (baseline) to postop (90 days after TKA surgery)
measure: Knee range of motion (ROM)
timeFrame: Change in knee ROM from preop (baseline) to postop (90 days after TKA surgery)
measure: Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale
timeFrame: Change in WOMAC pain subscale from preop (baseline) to postop (90 days after TKA surgery)
Other outcomes:
measure: Veterans Rand 12-item Health Survey (VR-12)
timeFrame: Collected at preop (baseline) and 90 days after TKA surgery
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Jennifer E. Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: