跳至主要内容
临床试验/NCT05449418
NCT05449418进行中(未招募)不适用

ENSPIRE: Engaging Staff to Improve COVID-19 Vaccination Response at Long-Term Care Facilities

Kaiser Permanente2 个研究点 分布在 1 个国家目标入组 988 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
988
试验地点
2
主要终点
Change in likelihood of recommending COVID-19 vaccination

研究概览

简要总结

The ENSPIRE study is a cluster-randomized comparative effectiveness trial being conducted within long-term care and residential facilities that will test a communication and engagement strategy for increasing COVID-19 booster vaccination rates against an enhanced usual care comparator (Centers for Disease Control and Prevention or other national organization vaccine education and communication materials) among facility staff. The communication and engagement strategy being tested includes (1) the development of materials co-designed with and tailored to facility staff whose primary language is a language other than English or who are from certain cultural affinity groups and (2) the distribution of the developed materials by members of the language/cultural affinity groups with peer advocacy activities (full intervention). The study is being conducted in Washington state and Georgia.

Long-term care/residential facilities will be asked to furnish their staff booster rate at 4 timepoints: pre-intervention, and one month (timepoint 1), 3 months (timepoint 2), and 6 months (timepoint 3) post-intervention. Staff at participating long-term care facilities will be invited to complete three online surveys at 3 timepoints: pre-intervention, 3 months post-intervention and 6 months post-intervention. Long-term care facilities will be randomized to a trial arm following the pre-intervention data collection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

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

  • •Works at a participating long-term care facility that has more than 50 staff members, has a staff COVID-19 booster vaccination rate of ≤60% as of December 1, 2021, and is located in Washington state or Georgia.
  • •18 years or older

排除标准

  • •Does not work at an enrolled long-term care facility
  • •17 years or younger

研究组 & 干预措施

Enhanced Usual Care

Active Comparator

Distribution of COVID-19 vaccine promotion materials from the Centers for Disease Control and Prevention [CDC] or other national organization with limited distribution support at long-term care centers.

干预措施: Enhanced Usual Care (Other)

Full Intervention

Experimental

Development of materials co-designed with and tailored to language/cultural affinity groups and distributed with assistance from co-design participants who will serve as peer advocates.

干预措施: Full Intervention (Behavioral)

结局指标

主要结局

Change in likelihood of recommending COVID-19 vaccination

时间窗: Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

Change in likelihood of recommending COVID-19 vaccination to others (coworkers, family, friends) assessed using a 6-item Net Promoter Score scale. The scale is assessed on an 11-point scale ranging from 0 ('Least Likely') to 10 ('Most Likely').

Change in COVID-19 booster vaccination rate

时间窗: Baseline (Time 0); 7 months post-randomization (Time 1); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3)

Change in percentage of staff at long-term care centers that have received a booster vaccine over time.

次要结局

  • Change in COVID-19 vaccine confidence(Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3))
  • Change in vaccine hesitancy(Baseline (Time 0); 10 months post-randomization (Time 2); 13 months post-randomization (Time 3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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