NCT04499391

COVID-19 Project ECHO in Nursing Homes

Completed NA Results posted Last updated 22 August 2024

What this trial tests

NA trial testing Project ECHO in Covid19 in 136 participants. Completed in 30 October 2022.

Timeline

4 December 2020

Primary endpoint
27 September 2022

30 October 2022

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	136
Start date	4 December 2020
Primary completion	27 September 2022
Estimated completion	30 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Project ECHO

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Milton S. Hershey Medical Center

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Infection Rate Primary · 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

Group	Value	95% CI
ECHO Plus	141.91	± 266.23
ECHO	106.57	± 192.49

4m

Group	Value	95% CI
ECHO Plus	1.54	± 6.62
ECHO	2.86	± 14.11

6m

Group	Value	95% CI
ECHO Plus	2.08	± 16.67
ECHO	0.83	± 5.04

12m

Group	Value	95% CI
ECHO Plus	28.01	± 54.48
ECHO	26.56	± 50.17

18m

Group	Value	95% CI
ECHO Plus	33.07	± 66.81
ECHO	30.5	± 74.18

Hospitalization Secondary · 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

Group	Value	95% CI
ECHO Plus	40.05	± 83.13
ECHO	39.12	± 83.88

4m

Group	Value	95% CI
ECHO Plus	3.09	± 14.01
ECHO	4.72	± 21.33

6m

Group	Value	95% CI
ECHO Plus	5.55	± 30.40
ECHO	5.18	± 37.47

12m

Group	Value	95% CI
ECHO Plus	24.57	± 113.55
ECHO	7.87	± 24.71

18m

Group	Value	95% CI
ECHO Plus	7.27	± 21.31
ECHO	13.58	± 55.54

Death Secondary · 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

Group	Value	95% CI
ECHO Plus	30.22	± 61.59
ECHO	31.98	± 66.2

4m

Group	Value	95% CI
ECHO Plus	0.82	± 4.39
ECHO	0.00	± 0.00

6m

Group	Value	95% CI
ECHO Plus	0.46	± 2.61
ECHO	0.30	± 2.35

12m

Group	Value	95% CI
ECHO Plus	3.60	± 12.51
ECHO	3.71	± 11.37

18m

Group	Value	95% CI
ECHO Plus	2.00	± 7.28
ECHO	0.19	± 1.49

Flu-like Illness Secondary · 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

Group	Value	95% CI
ECHO Plus	0.65	± 5.21
ECHO	0.00	± 0.00

4m

Group	Value	95% CI
ECHO Plus	0.00	± 0.00
ECHO	0.00	± 0.00

6m

Group	Value	95% CI
ECHO Plus	0.00	± 0.00
ECHO	0.62	± 4.88

12m

Group	Value	95% CI
ECHO Plus	0.35	± 2.78
ECHO	1.36	± 8.01

18m

Group	Value	95% CI
ECHO Plus	0.00	± 0.00
ECHO	0.00	± 0.00

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized trials on non-pharmaceutical interventions for COVID-19: a scoping review.
   Hirt J, Janiaud P, Hemkens LG. · · 2022 · cited 24× · PMID 35086864 · DOI 10.1136/bmjebm-2021-111825
2. Implementing Infection Control and Quality of Life Best Practices in Nursing Homes With Project ECHO: Protocol for a Patient-Centered Randomized Controlled Trial.
   Calo WA, Francis E, Kong L, Hogentogler R, et al · · 2022 · cited 9× · PMID 35476823 · DOI 10.2196/34480
3. Implementation of COVID-19 infection control best practices in nursing homes amid the pandemic.
   D'Souza GC, Kraschnewski JL, Francis E, Heilbrunn E, et al · · 2024 · cited 1× · PMID 39154191 · DOI 10.1186/s12913-024-11407-z
4. Underuse of SARS-CoV-2-Neutralizing Monoclonal Antibodies in Skilled Nursing Facilities.
   Paules CI, Osevala N, Lehman E, Heilbrunn ES, et al · · 2024 · PMID 37944905 · DOI 10.1016/j.jamda.2023.10.003
5. Randomized trials on non-pharmaceutical interventions for COVID-19 as of August 2021: a meta-epidemiological analysis
   Hirt J, Janiaud P, Hemkens LG. · · 2021 · DOI 10.1101/2021.08.20.21261687