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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04499391
Other study ID # PCORI Nursing Homes
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 4, 2020
Est. completion date October 2022

Study information

Verified date September 2022
Source Milton S. Hershey Medical Center
Contact Jennifer Kraschnewski
Phone 717-531-7778
Email jkraschnewski@pennstatehealth.psu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 136
Est. completion date October 2022
Est. primary completion date October 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infection rate Rate of COVID-19 infection in enrolled nursing homes Baseline, 4, 6, 12, 18 months
Secondary Hospitalization Number of COVID-19 hospitalizations from enrolled nursing homes Baseline, 4, 6, 12, 18 months
Secondary Death Number of COVID-19 deaths from enrolled nursing homes Baseline, 4, 6, 12, 18 months
Secondary Flu-like illness Number of flu-like illnesses reported from enrolled nursing homes Baseline, 4, 6, 12, 18 months
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