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

Prosthetic Joint Infection Clinical Trial

Official title:

Treating the Whole Patient: Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762706
• Other study ID #: 2101221058
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: West Virginia University
• Contact: Allison Lastinger, MD
• Phone: 304-293-3306
• Email: alastinger[@]hsc.wvu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infections
• Prosthetic Joint Infection

Intervention

Behavioral:
• CRUTCH Pathway
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.

Locations

Country	Name	City	State
United States	WVU Medicine University Town Center	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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