Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.
Primary Purpose
Prosthetic Joint Infection
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRUTCH Pathway
Sponsored by
About this trial
This is an interventional supportive care trial for Prosthetic Joint Infection
Eligibility Criteria
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.
Sites / Locations
- WVU Medicine University Town CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CRUTCH Pathway
Arm Description
A novel behavioral health program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04762706
First Posted
February 16, 2021
Last Updated
August 9, 2023
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT04762706
Brief Title
Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.
Official Title
Treating the Whole Patient: Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prosthetic Joint Infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRUTCH Pathway
Arm Type
Experimental
Arm Description
A novel behavioral health program.
Intervention Type
Behavioral
Intervention Name(s)
CRUTCH Pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess patient experience with a Distress Thermometer and Problem List
Description
Distress Thermometer and Problem List for Patients with a score from 0-10, where 0 is no distress and 10 extreme distress.
Time Frame
Two week post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allison Lastinger, MD
Phone
304-293-3306
Ext
3
Email
alastinger@hsc.wvu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Eicher, BS
Phone
304-285-7445
Email
jeicher@hsc.wvu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Lastinger, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Medicine University Town Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahar Saaid
Phone
304-285-7222
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Measuring Distress in Prosthetic Joint Infection Using a Standardized Metric: CRUTCH Pathway Pilot.
We'll reach out to this number within 24 hrs