Clinical trial NCT05900453: Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty
Official title: Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Keywords: precision medicine
prognosis
patient-centered care
Decision Support Systems, Clinical
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: ATI Physical Therapy
First posted: 2023-06-12
Enrollment: 675
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score - Joint Replacement (KOOS-JR)
timeFrame: KOOS-JR was assessed postoperatively up to 6 months after surgery
Secondary outcomes:
measure: Outpatient Physical Therapy Visit Utilization
timeFrame: All visits from initial evaluation to discharge up to 1 year after surgery
measure: Time Up and Go (TUG)
timeFrame: TUG was assessed postoperatively up to 6 months after surgery
measure: Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.
timeFrame: Surveys were assessed postoperatively up to 6 months after surgery
measure: Knee range of motion (ROM)
timeFrame: ROM was assessed postoperatively up to 6 months after surgery
Other outcomes:
Locations:
city: Greenville
country: United States
facility: ATI Physical Therapy
state: South Carolina
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer E Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: