NCT05270980已完成不适用
COVID-19 Serologic Strategies for Skilled Nursing Facilities (CERO)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Number of New COVID-19 Detected Infections Among Residents
研究概览
简要总结
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:
- 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
- To reduce reduced COVID-19 incidence rate compared to SNFs not using this novel staff-resident assignment strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group (Cohorting)
Experimental
干预措施: Cohorting (Other)
Control Group (No Cohorting)
No Intervention
结局指标
主要结局
Number of New COVID-19 Detected Infections Among Residents
时间窗: Up to Month 5
次要结局
- Number of New COVID-19 Detected Infections Among Staff(Up to Month 5)
- Number of Hospitalizations Over Time(Up to Month 5)
研究者
研究点 (2)
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