Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Replacement
• Intervention / Treatment: Other: Clinical decision support (CDS) tool

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 675

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • ATI Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who attend post-TKA rehabilitation at the participating outpatient physical therapy clinics in the Greenville, SC area.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Usual Care TKA rehabilitation; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: ATI Physical Therapy
• Investigators: Principal Investigator: Jennifer E Stevens-Lapsley, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 15, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: prognosis; patient-centered care; Decision Support Systems, Clinical; precision medicine
• Other Study ID Numbers: 18-1246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No