Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

Completed

• Conditions: Total Knee Replacement
• Interventions: Other: Clinical decision support (CDS) tool

• Registration Number: NCT05900453
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

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 Timeline

• Study Start: 2018-05-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 675

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDS tool TKA rehabilitation	Clinical decision support (CDS) tool	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).

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)	KOOS-JR was assessed postoperatively up to 6 months after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Knee range of motion (ROM)	ROM was assessed postoperatively up to 6 months after surgery	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.
Outpatient Physical Therapy Visit Utilization	All visits from initial evaluation to discharge up to 1 year after surgery	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.
Time Up and Go (TUG)	TUG was assessed postoperatively up to 6 months after surgery	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.
Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.	Surveys were assessed postoperatively up to 6 months after surgery	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).

Trial Locations

Locations (1)

ATI Physical Therapy; 🇺🇸 Greenville, South Carolina, United States