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

NCT ID: NCT04762706

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-04

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prosthetic Joint Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CRUTCH Pathway

A novel behavioral health program.

Group Type EXPERIMENTAL

CRUTCH Pathway

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

West Virginia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Allison Lastinger

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Allison Lastinger, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WVU Medicine University Town Center

Morgantown, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2101221058

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.