Covid19NCT04499391

COVID-19 Project ECHO in Nursing Homes

A study testing Project ECHO in people with Covid19, run by Milton S. Hershey Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: Project ECHO
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 136 participants
Where: 1 siteUnited States
Study dates: 4 Dec 2020to 30 Oct 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Covid19
Being tested: Project ECHO
Keywords: Project ECHO, telehealth
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Project ECHOOther
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.

Study groups in NCT04499391
Study group	Role	What they receive
ECHO plus	Experimental	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 Receives: Other: Project ECHO
ECHO	Active comparator	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 Receives: Other: Project ECHO

What is being measured

The primary outcome is the main question the study is designed to answer.

Infection Rate
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
Measured: Baseline, 4, 6, 12, 18 months

Secondary outcomes (3)

Hospitalization
Number of COVID-19 hospitalizations from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 admissions
Measured: Baseline, 4, 6, 12, 18 months
Death
Number of COVID-19 deaths from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 deaths
Measured: Baseline, 4, 6, 12, 18 months
Flu-like Illness
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
Measured: Baseline, 4, 6, 12, 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 202030 Oct 2022

First posted5 Aug 2020
Study start4 Dec 2020
Primary completion27 Sep 2022
Study completion30 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Covid19Studies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: stratified cluster randomized design
Masking: None (open label)
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04499391
Sponsor's protocol ID: PCORI Nursing Homes
Status last verified: Aug 2024
First submitted: 31 Jul 2020
Last updated: 22 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

D'Souza GC, Kraschnewski JL, Francis E, Heilbrunn E, Kong L, Lehman E, Osevala N, Urso J, Chamberlain L, Suda KM, McNeil L, Calo WA. Implementation of COVID-19 infection control best practices in nursing homes amid the pandemic. BMC Health Serv Res. 2024 Aug 17;24(1):941. doi: 10.1186/s12913-024-11407-z.
PubMed 39154191
Calo WA, Francis E, Kong L, Hogentogler R, Heilbrunn E, Fisher A, Hood N, Kraschnewski J. Implementing Infection Control and Quality of Life Best Practices in Nursing Homes With Project ECHO: Protocol for a Patient-Centered Randomized Controlled Trial. JMIR Res Protoc. 2022 May 13;11(5):e34480. doi: 10.2196/34480.
PubMed 35476823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04499391
Acronym / sponsor ID: PCORI Nursing Homes
Conditions: Covid19
Keywords: Project ECHO, telehealth
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Study start: 4 Dec 2020 (actual)
Primary completion: 27 Sep 2022 (actual)
Study completion: 30 Oct 2022 (actual)
First posted: 5 Aug 2020 (actual)
Results: Posted 22 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: stratified cluster randomized design

Arm	Type	Receives
ECHO plus	Experimental	Other: Project ECHONursing 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
ECHO	Active comparator	Other: Project ECHONursing 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Project ECHOProject 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.	Other	ECHO, ECHO plus

Primary outcome

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

3 secondary outcomes

Hospitalization
Time frame: Baseline, 4, 6, 12, 18 months
Death
Time frame: Baseline, 4, 6, 12, 18 months
Flu-like Illness
Time frame: Baseline, 4, 6, 12, 18 months

Results and safety

Results posted to the registry on 22 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ECHO Plus	–	–
ECHO	–	–

Primary outcome: Infection Rate

Time frame: Baseline, 4, 6, 12, 18 months. Mean (Standard Deviation). Unit: infections per 1,000 residents in 4 week

Measure	ECHO Plus n = NA	ECHO n = NA
Baseline	141.91 (266.23)	106.57 (192.49)
4m	1.54 (6.62)	2.86 (14.11)
6m	2.08 (16.67)	0.83 (5.04)
12m	28.01 (54.48)	26.56 (50.17)
18m	33.07 (66.81)	30.5 (74.18)

Population analysed: Nursing homes were assigned to Arms/Groups, participant level data is not available

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were not collected as patients were not enrolled in the study. This study included only secondary data.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECHO Plus	0 of 0	0 of 0	0
ECHO	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39154191D'Souza GC, Kraschnewski JL, Francis E, Heilbrunn E, Kong L, Lehman E, Osevala N, Urso J, Chamberlain L, Suda KM, McNeil L, Calo WA. Implementation of COVID-19 infection control best practices in nursing homes amid the pandemic. BMC Health Serv Res. 2024 Aug 17;24(1):941. doi: 10.1186/s12913-024-11407-z.
Derived from this study: PubMed 35476823Calo WA, Francis E, Kong L, Hogentogler R, Heilbrunn E, Fisher A, Hood N, Kraschnewski J. Implementing Infection Control and Quality of Life Best Practices in Nursing Homes With Project ECHO: Protocol for a Patient-Centered Randomized Controlled Trial. JMIR Res Protoc. 2022 May 13;11(5):e34480. doi: 10.2196/34480.
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.

Jennifer Kraschnewski principal investigator

Penn State College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Project ECHO in people with Covid19, run by Milton S. Hershey Medical Center 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?

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: finished, as of the sponsor's last update on 22 Aug 2024. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Infection Rate (time frame: Baseline, 4, 6, 12, 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04499391, which also lists 2 linked publications.

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 22 Aug 2024.