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COVID-19 Project ECHO in Nursing Homes

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04499391
Enrollment
136
Registered
2020-08-05
Start date
2020-12-04
Completion date
2022-10-30
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Project ECHO, telehealth

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

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.

Interventions

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.

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

stratified cluster randomized design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Infection RateBaseline, 4, 6, 12, 18 monthsRate 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

Secondary

MeasureTime frameDescription
HospitalizationBaseline, 4, 6, 12, 18 monthsNumber of COVID-19 hospitalizations from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 admissions
DeathBaseline, 4, 6, 12, 18 monthsNumber of COVID-19 deaths from enrolled nursing homes, as measured by Cumulative 4-week incidence at study points for Total COVID-19 deaths
Flu-like IllnessBaseline, 4, 6, 12, 18 monthsNumber 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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: 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.
0
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: 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.
64
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: 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.
0
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: 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.
62
Total126

Baseline characteristics

CharacteristicECHO PlusECHOTotal
Age, Categorical
<=18 years
NA Nursing homeNA Nursing homeNA Nursing home
Age, Categorical
>=65 years
NA Nursing homeNA Nursing homeNA Nursing home
Age, Categorical
Between 18 and 65 years
NA Nursing homeNA Nursing homeNA Nursing home
Baseline Infection Rate
None
11 Nursing home7 Nursing home18 Nursing home
Baseline Infection Rate
Some
53 Nursing home55 Nursing home108 Nursing home
Facility Payment Model
For-profit
41 Nursing home33 Nursing home74 Nursing home
Facility Payment Model
Not-for-profit
23 Nursing home29 Nursing home52 Nursing home
Facility Size
>=60 beds
47 Nursing home43 Nursing home90 Nursing home
Facility Size
<60 Beds
17 Nursing home19 Nursing home36 Nursing home
Facility Type
Independent
27 Nursing home32 Nursing home59 Nursing home
Facility Type
Networked
37 Nursing home30 Nursing home67 Nursing home
Location
Rural
26 Nursing home27 Nursing home53 Nursing home
Location
Urban
38 Nursing home35 Nursing home73 Nursing home
Memory Care Status
No
47 Nursing home52 Nursing home99 Nursing home
Memory Care Status
Yes
17 Nursing home10 Nursing home27 Nursing home
Race (NIH/OMB)
American Indian or Alaska Native
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
Asian
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
Black or African American
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
More than one race
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
Unknown or Not Reported
NA Nursing homeNA Nursing homeNA Nursing home
Race (NIH/OMB)
White
NA Nursing homeNA Nursing homeNA Nursing home
Sex: Female, Male
Female
NA Nursing homeNA Nursing homeNA Nursing home
Sex: Female, Male
Male
NA Nursing homeNA Nursing homeNA Nursing home

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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

Time frame: Baseline, 4, 6, 12, 18 months

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

ArmMeasureGroupValue (MEAN)Dispersion
ECHO PlusInfection Rate18m33.07 infections per 1,000 residents in 4 weekStandard Deviation 66.81
ECHO PlusInfection RateBaseline141.91 infections per 1,000 residents in 4 weekStandard Deviation 266.23
ECHO PlusInfection Rate4m1.54 infections per 1,000 residents in 4 weekStandard Deviation 6.62
ECHO PlusInfection Rate6m2.08 infections per 1,000 residents in 4 weekStandard Deviation 16.67
ECHO PlusInfection Rate12m28.01 infections per 1,000 residents in 4 weekStandard Deviation 54.48
ECHOInfection Rate12m26.56 infections per 1,000 residents in 4 weekStandard Deviation 50.17
ECHOInfection Rate6m0.83 infections per 1,000 residents in 4 weekStandard Deviation 5.04
ECHOInfection RateBaseline106.57 infections per 1,000 residents in 4 weekStandard Deviation 192.49
ECHOInfection Rate18m30.5 infections per 1,000 residents in 4 weekStandard Deviation 74.18
ECHOInfection Rate4m2.86 infections per 1,000 residents in 4 weekStandard Deviation 14.11
Secondary

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

Time frame: Baseline, 4, 6, 12, 18 months

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

ArmMeasureGroupValue (MEAN)Dispersion
ECHO PlusDeath6m0.46 per 1,000 residents in 4 weeksStandard Deviation 2.61
ECHO PlusDeath4m0.82 per 1,000 residents in 4 weeksStandard Deviation 4.39
ECHO PlusDeath12m3.60 per 1,000 residents in 4 weeksStandard Deviation 12.51
ECHO PlusDeathBaseline30.22 per 1,000 residents in 4 weeksStandard Deviation 61.59
ECHO PlusDeath18m2.00 per 1,000 residents in 4 weeksStandard Deviation 7.28
ECHODeathBaseline31.98 per 1,000 residents in 4 weeksStandard Deviation 66.2
ECHODeath6m0.30 per 1,000 residents in 4 weeksStandard Deviation 2.35
ECHODeath18m0.19 per 1,000 residents in 4 weeksStandard Deviation 1.49
ECHODeath4m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHODeath12m3.71 per 1,000 residents in 4 weeksStandard Deviation 11.37
Secondary

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

Time frame: Baseline, 4, 6, 12, 18 months

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

ArmMeasureGroupValue (MEAN)Dispersion
ECHO PlusFlu-like Illness12m0.35 per 1,000 residents in 4 weeksStandard Deviation 2.78
ECHO PlusFlu-like IllnessBaseline0.65 per 1,000 residents in 4 weeksStandard Deviation 5.21
ECHO PlusFlu-like Illness6m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHO PlusFlu-like Illness4m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHO PlusFlu-like Illness18m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHOFlu-like Illness4m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHOFlu-like Illness6m0.62 per 1,000 residents in 4 weeksStandard Deviation 4.88
ECHOFlu-like Illness12m1.36 per 1,000 residents in 4 weeksStandard Deviation 8.01
ECHOFlu-like Illness18m0.00 per 1,000 residents in 4 weeksStandard Deviation 0
ECHOFlu-like IllnessBaseline0.00 per 1,000 residents in 4 weeksStandard Deviation 0
Secondary

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

Time frame: Baseline, 4, 6, 12, 18 months

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

ArmMeasureGroupValue (MEAN)Dispersion
ECHO PlusHospitalization6m5.55 per 1,000 residents in 4 weeksStandard Deviation 30.4
ECHO PlusHospitalization12m24.57 per 1,000 residents in 4 weeksStandard Deviation 113.55
ECHO PlusHospitalization4m3.09 per 1,000 residents in 4 weeksStandard Deviation 14.01
ECHO PlusHospitalization18m7.27 per 1,000 residents in 4 weeksStandard Deviation 21.31
ECHO PlusHospitalizationBaseline40.05 per 1,000 residents in 4 weeksStandard Deviation 83.13
ECHOHospitalization18m13.58 per 1,000 residents in 4 weeksStandard Deviation 55.54
ECHOHospitalization4m4.72 per 1,000 residents in 4 weeksStandard Deviation 21.33
ECHOHospitalizationBaseline39.12 per 1,000 residents in 4 weeksStandard Deviation 83.88
ECHOHospitalization6m5.18 per 1,000 residents in 4 weeksStandard Deviation 37.47
ECHOHospitalization12m7.87 per 1,000 residents in 4 weeksStandard Deviation 24.71

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026