Interstitial Lung DiseasesNCT05455437
Monitoring and Evaluation Study of Project ECHO for ILD
An observational study of Interstitial Lung Diseases, run by Pulmonary Care and Research Collaborative Limited at 1 site in United States.
Trial summary
The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project ECHO for ILD at baseline, at 6 months, and at study end. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Diseases
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Who may be able to join
- Pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Pulmonary Care and Research Collaborative, Ltd.
Boston, Massachusetts, 02130
About this study
The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project ECHO for ILD at baseline, at 6 months, and at study end.
Read the detailed 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. It is a guided, technology-enabled collaborative practice model in which community providers become experts in an area of community need within the scope of their practice, operating with increasing independence as their skills and self-efficacy grow. The model establishes meaningful, ongoing relationships with hub specialists who serve as telementors for spoke providers and relies on case-based learning from presentations of real-world de-identified patient cases.
The overarching goal of the project is to implement and evaluate an adaptation of the ECHO model to interstitial lung disease (ILD) diagnosis and care among primary care physicians (PCPs) and community pulmonologists in non-urban or underserved communities.
- Conditions
- Interstitial Lung Diseases
- Keywords
- Progressive Fibrosing Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Associated With Systemic Sclerosis, Myositis-Associated Interstitial Lung Disease, Sarcoidosis, Hypersensitivity Pneumonitis, Pulmonary Fibrosis
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Alveolitis, Extrinsic Allergic, Pulmonary Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on procedural knowledge
Change in participants' skills or competence in knowing ILD testing and treatment procedures based on a Likert scale rating (1=no skill and 7=expert, teach other) included in the structured participant surveys administered at baseline, 6 months, and at study end.
Measured: Up to 18 months
Impact on local care utilization
Change of proportion of patients utilizing local ILD care services, including the frequency of local follow-up visits and testing. Change in scores will be calculated between structured participant surveys responses at baseline, 6 months, and at study end.
Measured: Up to 18 months
Secondary outcomes (2)
Time to ILD diagnosis
The amount of time it takes for a participant's patient to be given an established, named ILD diagnosis (IPAF, IPF, HP, CTD-ILD, myositis-ILD, idiopathic NSIP, etc.) from onset of respiratory symptoms and from the time of first pulmonologist appointment. This data will be obtained from teleECHO clinic management records and participants' case and follow-up reporting for patients who were presented to the ECHO for diagnosis.
Measured: Up to 18 months
Content expert facilitation
Proportion of participants who agree that the quality of content expert facilitation was adequate during the teleECHO session. This will be collected monthly from post-session surveys via a Likert scale (1=strongly disagree and 5=strongly agree).
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmonary Care and Research Collaborative Limited
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Aliaa Barakat, PhD, Principal investigator, Pulmonary Care and Research Collaborative, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455437
- Sponsor's protocol ID
- ILDC-002
- Status last verified
- Jul 2022
- First submitted
- 30 Jun 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Evaluation Study of Project ECHO for ILD
- ClinicalTrials.gov ID
- NCT05455437
- Acronym / sponsor ID
- ILDC-002
- Conditions
- Interstitial Lung Diseases
- Keywords
- Progressive Fibrosing Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease Associated With Systemic Sclerosis, Myositis-Associated Interstitial Lung Disease, Sarcoidosis, Hypersensitivity Pneumonitis, Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Pulmonary Care and Research Collaborative LimitedUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will utilize pre-post survey measures to evaluate Project ECHO for ILD with respect to an initial set of practice and clinical outcomes and relies on questionnaire data obtained from providers participating in Project ECHO for ILD at baseline, at 6 months, and at study end.
Detailed 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. It is a guided, technology-enabled collaborative practice model in which community providers become experts in an area of community need within the scope of their practice, operating with increasing independence as their skills and self-efficacy grow. The model establishes meaningful, ongoing relationships with hub specialists who serve as telementors for spoke providers and relies on case-based learning from presentations of real-world de-identified patient cases.
The overarching goal of the project is to implement and evaluate an adaptation of the ECHO model to interstitial lung disease (ILD) diagnosis and care among primary care physicians (PCPs) and community pulmonologists in non-urban or underserved communities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Key inclusion criteria (1 listed)
- Pulmonologists and primary care physicians who participate in Project ECHO for ILD.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact on procedural knowledge
Time frame: Up to 18 months
Change in participants' skills or competence in knowing ILD testing and treatment procedures based on a Likert scale rating (1=no skill and 7=expert, teach other) included in the structured participant surveys administered at baseline, 6 months, and at study end.
Impact on local care utilization
Time frame: Up to 18 months
Change of proportion of patients utilizing local ILD care services, including the frequency of local follow-up visits and testing. Change in scores will be calculated between structured participant surveys responses at baseline, 6 months, and at study end.
2 secondary outcomes
Time to ILD diagnosis
Time frame: Up to 18 months
Content expert facilitation
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Barakat, PhD principal investigator
Pulmonary Care and Research Collaborative, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Diseases, run by Pulmonary Care and Research Collaborative Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on procedural knowledge (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.