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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05450276
Other study ID # ILDC-003
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date July 2022
Est. completion date March 2024

Study information

Verified date July 2022
Source Pulmonary Care and Research Collaborative Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study will assess whether patients of providers participating in Project ECHO for ILD experience reduced stress, including financial stress, based on their ability to receive timely and local care and services, The study will employ nested mixed-method design at baseline, at 6 months and at 12 months to answer the study question.


Description:

Project ECHO (Extension for Community Healthcare Outcomes) is a knowledge-sharing model to expand the capacity of the health care workforce so that more people can get high quality care for their health conditions in or near the communities where they live. The model brings specialty disease expertise to community providers through its hub-and-spoke networks. The model relies on videoconferencing to connect local providers in non-urban or underserved communities (spoke sites) with an interdisciplinary team of specialist providers at academic medical centers (hubs) during virtual "teleECHO" clinic sessions, which include brief educational lectures and case-based, experiential learning. The ECHO model addresses barriers of long wait times for a first appointment, the time and expense associated with long distance travel, and the disinclination to follow through on repeated care appointments in the face of these persistent barriers, all with the additional objective of achieving health equity. Most patients perceive the diagnostic and care pathways in ILDs as a major struggle because of lack of awareness about the diseases, delayed access to specialty centers, providers' focus on disease- versus patient-centered care, and lack of reliable information and education about the diseases and supportive care resources.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 56
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed diagnosis of interstitial lung disease - Not be currently followed by an ILD specialist at an academic institution or must live more than 50 miles away from an academic ILD center Exclusion Criteria: -

Study Design


Locations

Country Name City State
United States Pulmonary Care and Research Collaborative, Ltd. Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Pulmonary Care and Research Collaborative Limited Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in patients' stress level Assessed by the Perceived Stress Scale at baseline, 6 months, and at study end. The range of scores is 0-40, with higher scores indicating more appraised stress. Up to 18 months
Primary Patients' satisfaction of care Assessed by the Patient Satisfaction Survey, a self-report scale assessing patient experience and satisfaction with local ILD care, which is composed of 28 items rated on a Likert Scale and Yes/No grading; the summed items produce a single satisfaction score. Up to 18 months
Secondary Change in patients' perceptions regarding local ILD care Patient participants in the study will complete interviews at baseline (their community PCP or pulmonologist attending their first ILD teleECHO clinic), at 6 months and at 12 months. The interviews will be open-ended to solicit the perspectives of participants regarding their experience with the local ILD care in their communities before, during and after their PCPs or local pulmonologists participate in Project ECHO for ILD. Up to 18 months
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