Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Study Overview
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Brief Summary
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This study will compare the postoperative recovery of two patient cohorts who attended outpatient physical therapy at two clinics in the Greenville, South Carolina area. The Usual Care cohort received care according to each clinic's pre-existing care guidelines. The CDS Cohort received care informed by a new clinical decision support (CDS) tool.

Detailed Description
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In this cohort study, the investigators will use regression to examine whether CDS tool exposure was associated with patient outcomes after total knee replacement. Linear mixed effect models will be used for continuous outcomes that have multiple assessment points per patient. For count outcomes (e.g., visit utilization), the investigators will use Poisson/negative binomial regression or linear regression with appropriate outcome transformations.

Official Title
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Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Other: Clinical decision support (CDS) tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient underwent TKA for primary knee osteoarthritis Patient underwent postoperative TKA rehabilitation at one of the two participating physical therapy clinics in the Greenville, SC area Exclusion Criteria: Patients < 40 years old Patients whose total episode of care length in outpatient physical therapy was < 21 days Patients who attended < 3 outpatient physical therapy visits throughout their episode of care Outcomes collected > 6 months after surgery (except for visit utilization, which can include data up to 1 year after surgery) Patients who were not exposed to the CDS tool, but were treated by a clinician who was trained to use the CDS tool

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Usual Care TKA rehabilitation<br>This cohort of patients received Usual Care TKA rehabilitation at two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients received treatment guided by their clinician's professional judgment and the clinic's best practice guidelines for TKA. | |
| CDS tool TKA rehabilitation<br>This cohort of patients received TKA rehabilitation at the same two outpatient physical therapy clinics in the Greenville, South Carolina, USA area. These patients also received treatment guided by their clinician's professional judgement and the clinic's best practice guidelines. Additionally, this cohort of patients was exposed to the CDS tool (i.e., clinicians used the tool to view personalized information about the patient at least once during the patient's episode of care). | Other: Clinical decision support (CDS) tool<br>* The web-based clinical decision support (CDS) tool uses patient information (e.g., age, sex, BMI, perioperative status) to create personalized predictions of recovery following knee replacement. The CDS tool predicts range of motion, physical function, and pain recovery. Clinicians can use these predictions to (1) inform patients of their expected prognosis, (2) monitor patients' recovery against their predicted recovery, and (3) tailor treatments according to individual patients' needs. Clinicians were provided with basic training for how to use the CDS tool, and were given examples of how to integrate it into clinical care. However, the CDS tool did not dictate any treatment decisions; clinicians were free to use the CDS tool at their discretion to inform decision making.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR) | The KOOS-JR is a patient-reported measure of physical function developed specifically for patients with total knee arthroplasty (TKA). The KOOS-JR is scored on a 100-point scale with 0 representing complete knee disability and 100 representing perfect knee health. It can be completed quickly (only 7 items) and has established validity, reliability, and responsiveness in the TKA population. | KOOS-JR was assessed postoperatively up to 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outpatient Physical Therapy Visit Utilization | The total number of outpatient physical therapy visits attended by each patient during the year immediately following their TKA will be extracted from the electronic medical record. Only visits associated with the patient's episode of care for TKA will be included. | All visits from initial evaluation to discharge up to 1 year after surgery | 
| Time Up and Go (TUG) | The TUG is a basic measure of mobility and balance that consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. The TUG is responsive to change with adequate reliability in the acute recovery period after TKA. | TUG was assessed postoperatively up to 6 months after surgery | 
| Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation. | Patients completed surveys regarding their perceived knowledge of their postoperative recovery and their engagement in rehabilitation decision making. The surveys were scored on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). | Surveys were assessed postoperatively up to 6 months after surgery | 
| Knee range of motion (ROM) | Knee flexion and extension ROM was measured manually by goniometry, which is a valid and reliable technique for measuring knee mobility. Recovery of ROM after TKA is necessary for many functional activities and is emphasized in rehabilitation after TKA. | ROM was assessed postoperatively up to 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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precision medicine, prognosis, patient-centered care, Decision Support Systems, Clinical