Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.

Not Applicable

Completed

• Conditions: Prosthetic Joint Infection
• Interventions: Behavioral: CRUTCH Pathway

• Registration Number: NCT04762706
• Lead Sponsor: West Virginia University

Brief Summary

The purpose of this study is to determine whether patients being treated for prosthetic joint infections (PJI) experience distress during the course of their treatment and how distress influences various aspects of their lives. WVU expects to enroll approximately 12 subjects. Patients identified as scoring ≥4 on the Distress Thermometer at the two-week follow-up visit will be offered the opportunity to participate in the novel CRUTCH Pathway. Once enrolled, you will meet virtually with a mental health provider. The mental health provider will complete a 30-minute intake visit where he will review your distress thermometer scoring, discuss contributing factors to current distress level, and assess for psychiatric comorbidities.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-21
• Study Start: 2021-03-04
• Primary Completion: 2024-01-01
• Status Verified: 2024-07
• Study Completion: 2024-07-01
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• ability to speak and read English, and cognitively sound. Patients scheduled for revision of total hip or knee arthroplasty will be categorized as septic or aseptic revisions. Patients identified as scoring ≥4 on the DT at the two-week follow-up visit.

Exclusion Criteria

• Patients younger than 18 or older than 89, patients unable to speak and/or read English, and patients who are not able to understand and answer questions asked on surveys. Elective primary total hip or knee arthroplasty, hemiarthroplasty, unicompartmental knee arthroplasty.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CRUTCH Pathway	CRUTCH Pathway	A novel behavioral health program.

Primary Outcome Measures

Name	Time	Method
Assess patient experience with a Distress Thermometer and Problem List	Two week post operative	Distress Thermometer and Problem List for Patients with a score from 0-10, where 0 is no distress and 10 extreme distress.

Trial Locations

Locations (1)

WVU Medicine University Town Center; 🇺🇸 Morgantown, West Virginia, United States