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

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

COVID-19

Treatments

Other: Cohorting

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05270980
3U54AG063546-02S4 (U.S. NIH Grant/Contract)
20-01281

Details and patient eligibility

About

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.

Enrollment

87 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

87 participants in 2 patient groups

Intervention Group (Cohorting)
Experimental group
Treatment:
Other: Cohorting
Control Group (No Cohorting)
No Intervention group

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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