Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

NCT ID: NCT05900453

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 675 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-15
• Study Completion Date: 2022-12-30

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.

Conditions

Total Knee Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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).

Clinical decision support (CDS) tool

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ATI Physical Therapy

UNKNOWN

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer E Stevens-Lapsley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

ATI Physical Therapy

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

18-1246

Identifier Type: -

Identifier Source: org_study_id