COVID-19 Project ECHO in Nursing Homes

Sponsor

Milton S. Hershey Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04499391

Collaborator

(none)

136

Enrollment

Location

Arms

20.9

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Other: Project ECHO	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

stratified cluster randomized designstratified cluster randomized design

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

COVID-19 Project ECHO for Nursing Homes: A Patient-centered, Randomized-controlled Trial to Implement Infection Control and Quality of Life Best Practice

Actual Study Start Date :

Dec 4, 2020

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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	Other: Project ECHO 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	Other: Project ECHO 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.

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

Other: Project ECHO

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

Other: Project ECHO

Outcome Measures

Primary Outcome Measures

Infection rate [Baseline, 4, 6, 12, 18 months]
Rate of COVID-19 infection in enrolled nursing homes

Secondary Outcome Measures

Hospitalization [Baseline, 4, 6, 12, 18 months]
Number of COVID-19 hospitalizations from enrolled nursing homes
Death [Baseline, 4, 6, 12, 18 months]
Number of COVID-19 deaths from enrolled nursing homes
Flu-like illness [Baseline, 4, 6, 12, 18 months]
Number of flu-like illnesses reported from enrolled nursing homes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033

Sponsors and Collaborators

Milton S. Hershey Medical Center

Investigators

Principal Investigator: Jennifer Kraschnewski, Penn State College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Kraschnewski, Associate Professor and Vice Chair for Research, Department of Medicine, Milton S. Hershey Medical Center

ClinicalTrials.gov Identifier:

NCT04499391

Other Study ID Numbers:

PCORI Nursing Homes

First Posted:

Aug 5, 2020

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jennifer Kraschnewski, Associate Professor and Vice Chair for Research, Department of Medicine, Milton S. Hershey Medical Center

Project ECHO

telehealth

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Aug 23, 2022