Novel Strategies for Personalized Clinical Decisions in Knee Arthroplasty

NCT05900453 | Completed

• 1 other identifier: 18-1246
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Replacement

Keywords

precision medicine; prognosis; patient-centered care; Decision Support Systems, Clinical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Outpatient Physical Therapy Visit Utilization

  All visits from initial evaluation to discharge up to 1 year after surgery

• Time Up and Go (TUG)

  TUG was assessed postoperatively up to 6 months after surgery

• Surveys of patients' perceived knowledge of their recovery and engagement in their rehabilitation.

  Surveys were assessed postoperatively up to 6 months after surgery

• Knee range of motion (ROM)

  ROM was assessed postoperatively up to 6 months after surgery

Study Arms (2)

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

Interventions

Clinical decision support (CDS) tool 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.

CDS tool TKA rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• ATI Physical Therapy: collaborator

Study Sites (1)

ATI Physical Therapy

Greenville, South Carolina, 29601, United States

Location

MeSH Terms

Interventions

Compact Disks; Equipment and Supplies

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Jennifer E Stevens-Lapsley, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 12, 2023
• Study Start: May 15, 2018
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)