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OpenTrials
Completed

NCT Number: NCT05270980

COVID-19 Serologic Strategies for Skilled Nursing Facilities

The COVID-19 pandemic ravaged United States skilled-nursing facilities (SNFs). Novel strategies that maximize the safety and quality of life for SNF residents with ADRD and staff who care for them are urgently needed. Thus, the study's objectives are:

1. To rapidly plan and pilot test an intervention that leverages COVID-19 antibody and PCR status to pair SNF staff with residents in the safest way possible 2. To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ArchCare at Mary Manning Walsh Home (MMW), New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Staff Stakeholders:

  • Must be employees of ArchCare
  • Must be members of included unit staff or those that float on those designated units
  • Willing to participate in focus groups or semi-structured interviews with study team

Inclusion criteria

for Family Participants:

  • Family members of residents who reside at either TCC or MMW (ArchCare facilities)
  • Family member of resident who is on designated study unit or eligible to be transferred to such unit
  • Willing to participate in focus groups or semi-structured interviews with study team

Inclusion criteria

for Resident Participants:

  • Resident has ability to communicate and follow simple commands
  • Resident has ability to communicate and follow simple commands
  • English- or Spanish-speaking
  • Resident has capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.
  • Must agree to have serologic testing for COVID-19
  • Agrees to remain on one of the facility units of study or to be transferred to such unit

Exclusion criteria

for Staff Stakeholders:

  • Not employees of ArchCare
  • Not members of included unit staff or those that float on those designated units
  • Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion criteria

for Family Participants:

  • Not family members of residents who reside at either TCC or MMW (ArchCare facilities)
  • Not family member of resident who is on designated study unit or eligible to be transferred to such unit
  • Not willing to participate in focus groups or semi-structured interviews with study team

Exclusion criteria

for Resident Participants:

  • Resident is not living in the unit of intervention
  • Resident does not have ability to communicate and follow simple commands
  • Not English- or Spanish-speaking
  • Resident lacks capacity to consent assessed with standard questions used to assess capacity and does not have a surrogate who can provide consent.
  • If resident lacks capacity, that resident does not assent with surrogate who provides assent
  • Does not agree to have serologic testing for COVID-19
  • Refuses to agree to remain on one of the facility units of study or to be transferred to such unit

Treatment and study plan

Cohorting

Other

The cohorting strategy will result in "pairing" serology-positive staff with serology-negative residents and serology-negative staff and serology-positive residents to the degree that penetration of serologic presumed immunity allows this pairing to be positive. Any resident who refuses serology testing will be treated as if they are serology negative as the safest strategy for risk of unwanted exposure.

Primary outcomes

  1. Number of New COVID-19 Detected Infections Among Residents

    Time frame: Up to Month 5

Secondary outcomes

  1. Number of New COVID-19 Detected Infections Among Staff

    Time frame: Up to Month 5

  2. Number of Hospitalizations Over Time

    Time frame: Up to Month 5

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Brown University
  • National Institute on Aging (NIA)

Registry information

Official study title

COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)

Acronym: CERO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 8, 2022
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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