- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04499391
COVID-19 Project ECHO in Nursing Homes
August 19, 2024 updated by: Jennifer Kraschnewski, Milton S. Hershey Medical Center
COVID-19 Project ECHO for Nursing Homes: A Patient-centered, Randomized-controlled Trial to Implement Infection Control and Quality of Life Best Practice
Nursing homes are ground zero for the COVID-19 pandemic.
Nursing homes are ill-equipped for the pandemic; though facilities are required to have infection control staff, only 3% have taken a basic infection control course.
Significant research has focused on infection control in the acute care setting.
However, little is known about the implementation of practices and effective interventions in long-term care facilities.The investigators propose an intervention utilizing Project ECHO, an evidence-based telehealth model, to connect Penn State University experts with remote nursing home staff and administrators to proactively support evidence-based infection control guideline implementation.
Our study seeks to answer the critical research question of how evidence-based infection control guidelines can be implemented effectively in nursing homes
Study Overview
Detailed Description
The investigators will recruit 200 nursing homes with approximately 24,560 residents from across the United States through collaborations with our stakeholders.
Nursing homes will be randomized to one of two arms: 1) AHRQ-funded COVID-19 ECHO that includes 16 weekly telehealth sessions addressing COVID-19 guidelines and best practices or 2) AHRQ-funded COVID-19 ECHO plus an additional 9 sessions with a focus on CDC infection control training.
Randomization will be stratified by characteristics of nursing homes to ensure balance among the two trial groups, including size (number of beds),geographic location, and current COVID-19 infection rate.
Patient-centered outcomes (nursing home residents with COVID-19 infections, hospitalizations, deaths, and QOL) will be assessed at baseline, 4, 6, 12, and 18 months.
Our study is guided by the RE-AIM framework to critically evaluate both effectiveness and implementation outcomes of the proposed intervention.
The RE-AIM framework is frequently utilized to improve sustainable adoption and implementation of effective, generalizable, evidence-based interventions like Project ECHO.
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria for Facilities Skilled Nursing Facility in United States Access to computer or electronic device
Exclusion Criteria for Facilities Previously participated in Project ECHO COVID-19 series either through Penn State or another institution
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ECHO plus
Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants.
Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times.
Participants in this arm will receive a 2 month (8 sessions total) refresher course in Fall 2021.
Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation
|
Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation.
This differentiates ECHO from traditional learning and facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care.studying
innovative approaches.
|
|
Active Comparator: ECHO
Nursing homes in this arm will receive the intervention via real-time, interactive videoconferencing using Zoom at no cost to participants.
Sessions will be 90 minutes in duration and held weekly for 6 months (25 sessions total) at regularly scheduled times.
Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation
|
Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation.
This differentiates ECHO from traditional learning and facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care.studying
innovative approaches.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Infection Rate
Time Frame: Baseline, 4, 6, 12, 18 months
|
Rate of COVID-19 infection in enrolled nursing homes, as measured by the cumulative 4-week incidence at study points for Confirmed COVID-19 cases per 1,000 residents
|
Baseline, 4, 6, 12, 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalization
Time Frame: Baseline, 4, 6, 12, 18 months
|
Number of COVID-19 hospitalizations from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 admissions
|
Baseline, 4, 6, 12, 18 months
|
|
Death
Time Frame: Baseline, 4, 6, 12, 18 months
|
Number of COVID-19 deaths from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 deaths
|
Baseline, 4, 6, 12, 18 months
|
|
Flu-like Illness
Time Frame: Baseline, 4, 6, 12, 18 months
|
Number of flu-like illnesses reported from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total confirmed new influenza per 1,000 residents in 4 weeks
|
Baseline, 4, 6, 12, 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Kraschnewski, Penn State College of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2020
Primary Completion (Actual)
September 27, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
July 31, 2020
First Submitted That Met QC Criteria
August 3, 2020
First Posted (Actual)
August 5, 2020
Study Record Updates
Last Update Posted (Actual)
August 22, 2024
Last Update Submitted That Met QC Criteria
August 19, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCORI Nursing Homes
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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