IMPACT-C: Improving Vaccine Uptake in Skilled Nursing Facilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23,768
- 试验地点
- 4
- 主要终点
- Number of Residents Who Received SARS-CoV-2 Vaccine
研究概览
简要总结
SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators will develop and implement a scalable multi-pronged intervention that educates, builds trust and supports the informed consent process aimed to increase SARS-CoV-2 vaccination.
The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged 'high touch' intervention to reduce vaccine hesitancy in skilled nursing facility staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators will provide additional funds to support COVID-19 testing, in order that facilities have access to enough testing kits for patient or staff who develops symptoms following vaccination.
This trial will be randomized within four SNF chains in order to evaluate the effect of a multi-pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-stay nursing home residents. In four chains, eligible facilities will undergo randomization between usual care versus adding the 'high touch' intervention, implemented in two waves. Randomization and roll out of the intervention will occur at the facility level.
The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs with the intervention will have at least a 10 percentage point greater vaccine uptake of vaccine than staff in SNFs that do not participate in the high touch intervention; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.
详细描述
An IRB waiver of consent was obtained for this study. The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged "high touch" intervention to reduce vaccine hesitancy in skilled nursing facility (SNF) staff and residents among a random sample of facilities across four SNF chains. This will be a cluster randomized trial where the intervention is applied at the facility level. The primary interest is the effect of this intervention on SNFs that are characterized by having a relatively high proportion of residents who are Black or Latinx. The four SNF chains that have been selected have already given assent to participate in this trial. The facilities will then be stratified into three categories based on racial composition of residents:
- < 25% Black and Latinx residents
- 25-40% Black and Latinx residents
- > 40% Black and Latinx residents
Facilities will undergo constrained randomization within each chain and stratum to ensure that the proportion of Black and Latinx residents is balanced across the intervention arms. A total of 60 SNFs will be randomized to the intervention, allocated proportionally across the strata. The SNFs that were removed due to institutional instability will be compared separately to the control arm to assess potential bias due to selection into the study. Staff in facilities randomized to intervention arm will be informed by corporate leadership that they will be participating in a program to maximize COVID 19 vaccination among staff and residents. They will not be informed that this is part of a trial. Individual SNFs will be randomized to the intervention or usual care; randomization will be stratified by chain and by the proportion of minority residents based on three groups: <25%, 25%-40%, >40%. The research implementation team will not be masked to facility assignment. However, the PIs, the lead statistician, and programmers will be masked.
All SNFs in the four chains are prepared to receive electronic messaging and educational material (i.e., usual care) through the American Health Care Association (AHCA). Within the four SNF chains that have agreed to participate in the trial, the investigators will ask the CEOs if there are any facilities that should be excluded due to leadership instability or other inability to participate in the multi-pronged intervention. Remaining facilities will be randomized to additionally receive the multi-pronged intervention versus continuing usual care.
The entire trial will take place over 11-15 weeks: each facility in the high touch intervention will be involved in approximately 1-3 week start up activities, 6-8 weeks of vaccine administration (three scheduled deliveries for vaccine approximately 3-4 weeks a part), and 4 weeks of data collection. Facilities in the usual care group will follow the same timeline for enrollment and data collection. During the start-up period in the high touch facilities, the research team works with the leadership and opinion leaders in each SNF to optimize program roll-out within each unique environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Residents: Long-stay residents who have been in one of our participating skilled nursing facilities (SNFs) for at least 100 days and who are alive on the date that the first round of vaccines is available.
- •Staff: Staff providing care in one of our participating skilled nursing facilities during the vaccine clinics.
排除标准
- •Facilities: Facilities with evidence of institutional instability at time of recruitment or otherwise determined by the SNF CEO to be unable to participate in the high touch intervention.
- •Residents: Residents who have been in one of our participating SNFs for less than 100 days or who died or were transferred before the date the first vaccine was delivered to the facility.
- •Staff: Staff who are not a "usual" provider within the SNF (for instance, a visiting hospice provider).
研究组 & 干预措施
Usual care
Facilities in the 'usual care' arm will be offered electronic messaging and education regarding the COVID-19 vaccine. This material stems from the Centers for Disease Control and Prevention (CDC) and AMDA - The Society for Post-Acute and Long-Term Care Medicine (AMDA) resources and represents a suggested approach to reduce vaccine hesitancy in staff and residents/proxies (e.g., legally authorized representatives, powers of attorney). This electronic quality improvement (QI) material will be developed as part of a QI initiative and disseminated by the American Health Care Association (AHCA) to the SNF chains and using social media.
High touch
Facilities in the 'high touch' arm will receive the same electronic messaging and educational material as in the 'usual care' arm but will receive an additional high touch multi-pronged behavioral intervention.
干预措施: High touch multi-pronged behavioral intervention (Behavioral)
结局指标
主要结局
Number of Residents Who Received SARS-CoV-2 Vaccine
时间窗: 15 weeks
A binary measure (Yes or No) indicating whether a long stay nursing home resident received any dose of a SARS-CoV-2 vaccine, identified by the electronic medical records (EMR) within the study period.
次要结局
- Number of Staff Who Received SARS-CoV-2 Vaccine(15 weeks)