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

NCT04762706 | Completed

• 1 other identifier: 2101221058
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Assess patient experience with a Distress Thermometer and Problem List

  Distress Thermometer and Problem List for Patients with a score from 0-10, where 0 is no distress and 10 extreme distress.

  Two week post operative

Study Arms (1)

CRUTCH Pathway

EXPERIMENTAL

A novel behavioral health program.

Behavioral: CRUTCH Pathway

Interventions

CRUTCH Pathway BEHAVIORAL

Patients will be offered referral to a behavioral medicine specialist in the novel Combined Rehabilitation Using Team Centered Help (CRUTCH) Pathway. Once enrolled, these patients will meet virtually with a psychiatrist. The psychiatrist will complete a 30-minute intake visit where he will review the patient's DT scoring, discuss contributing factors to current distress level, and assess for psychiatric comorbidities. Following this assessment, psychotherapy, psychotropic medication, and referral for social work/financial services will be offered to the patient as indicated. If more frequent behavioral health follow-up is clinically indicated, it will be provided to the patients.

CRUTCH Pathway

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine University Town Center

Morgantown, West Virginia, 26501, United States

Location

Study Officials

• Allison Lastinger, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 21, 2021
• Study Start: March 4, 2021
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)