PCORI was created to improve the evidence about what works in health care, to better inform real, specific choices faced by patients, caregivers, clinicians, healthcare administrators, and others in the healthcare community. The COVID-19 pandemic has taken a terrible toll on communities across the country and brought with it unprecedented challenges to the US healthcare system. As of April 2021, the pandemic has resulted in more than 30,000,000 cases and over half a million deaths in the United States alone.[1]
Moreover, the pandemic has disproportionately impacted communities of color; racial, ethnic, or sexual and gender groups; and those of lower socioeconomic status; among others. Early in the pandemic, long-term care (LTC) facilities were epicenters of COVID-19 outbreaks, accounting for a large share of COVID-19-related deaths.[2]
Although the availability of several efficacious COVID-19 vaccines offers the promise of ending the pandemic, that outcome depends on widespread uptake of the vaccine. A key determinant of uptake is vaccine confidence: the trust that patients, families, and healthcare workers have in authorized vaccines; those who administer vaccines; and processes and policies that lead to vaccine development, authorization, manufacturing, and recommendations for use. Widespread vaccine acceptance hinges on building confidence and trust through transparent, culturally responsive communication that provides balanced and accurate information on vaccination benefits and risks.
Low vaccination coverage among individuals working in LTC settings was described in a February 2021 Centers for Disease Control and Prevention report and recounted widely in the media.[3] LTC settings include nursing facility care, adult day programs, retirement communities, post-acute rehab centers, assisted living facilities, and community-based services. Although efforts to promote confidence in COVID-19 vaccination among LTC workers are ongoing, a November 2020 survey found that only 45 percent of respondents were willing to receive a COVID-19 vaccine immediately once available and an additional 24 percent would consider it in the future.[4] Frequently cited reasons for lack of vaccine confidence included the perceived rapidity of vaccine development; inadequate information received about vaccine safety, side effects, and administration; and skepticism regarding the clinical trials and vaccine authorization processes.
Per an April 2020 Kaiser Family Foundation report,[5] the LTC workforce consists of a variety of occupations and workers with different levels of direct day-to-day patient contact, but most of the 4.5 million LTC workers are in close, frequent contact with patients. The vast majority of the LTC workforce is female (82 percent). Nearly half of aides and personal care workers are Black or Latinx (32 percent and 16 percent, respectively), and approximately one in four direct-care workers in LTC settings was born in a foreign country.[6] LTC workers overall are also disproportionately lower-wage earners and have less formal education. About one-third live in a family with income below 200 percent of the federal poverty level, and nearly 40 percent have a high school diploma or less.
Increasing vaccine confidence and uptake among LTC workers requires consideration of these demographic, cultural, and socioeconomic factors. In addition, interventions need to take into account the structural challenges of LTC settings, including long-standing personnel shortages, high turnover, individuals working in multiple settings, and limited resources for worker outreach and education.[7] Increasing confidence and uptake among LTC workers is critical to protecting the workers themselves; other workers with whom they come into contact; the patients and families they serve; and the loved ones, friends, and neighbors in the communities where they reside.
In the COVID-19 Targeted PFA released in May 2020, PCORI made healthcare workforce well-being a key priority. In keeping with this priority, PCORI is issuing a new research funding announcement with an accelerated funding and results-generating timeline to support innovative, high-impact studies that fit clearly within PCORI’s core mission of patient-engaged and patient-centered comparative clinical effectiveness research.
Research Question
For this funding opportunity, PCORI encourages applicants to address the following question: What interventions are effective in increasing COVID-19 vaccine confidence and uptake among LTC workers?
Interventions include, but are not limited to, the following (please note that interventions may be combined):
- Educational, communication, and behavioral economics strategies, tools, or approaches
- System- or organizational-level responses
- Digital marketing (e.g., social media, mobile) and other innovative technologies
- Single- versus two-dose vaccines
- Culturally specific and/or community competent approaches for reducing barriers
Additional questions that may be addressed for relevant subpopulations, settings, and interventions may include the following:
- What interventions and strategies are most effective to increase the acceptance of vaccines among populations of LTC workers who experience health disparities?
- How can evidence be integrated into vaccine promotion interventions to identify and address the sources of misinformation regarding vaccination?
Exclusive primary outcomes: COVID-19 vaccine uptake and/or vaccine series completion
Note: For this PFA, selection of either or both of the primary outcomes listed above is required. No other primary outcomes may be selected. If other primary outcomes are included in the application, the application will be deemed nonresponsive to this funding announcement.
Secondary outcomes (may include as appropriate, but are not limited to the following): COVID-19 vaccine confidence and vaccine hesitancy; community/social vaccine beliefs, misconceptions, misinformation, norms, and risk perceptions; adherence to COVID-19 vaccine protocols; COVID-19 vaccine distribution and implementation across various sectors/settings; implementation of policies to increase individual access and uptake; access to immunization services; service delivery improvements; trust in science supporting COVID-19 vaccine research; trust in government and health organizations providing COVID-19 vaccine recommendations; anxiety and stigma; and employment-related outcomes (e.g., lost days from work, continuity of the workforce, employee turnover)
Note: The inclusion of many secondary outcomes is generally discouraged. Secondary outcomes are typically used to assess additional effects after positive results are evident on the primary outcomes. If an outcome is merely for exploratory purposes, such outcomes should be so classified.
Important Study Considerations
Study design: PCORI encourages the use of diverse methods, including interventional study designs (e.g., a parallel group or cluster-randomized trial, an individually randomized group treatment trial, a stepped-wedge design) and observational designs (including natural experiments), to conduct research on an accelerated timeline. Hybrid designs, which can provide insight into implementation approaches in the context of evidence generation, will also be considered.
Disproportionately affected populations of LTC workers and health disparities: Given the diverse populations that compose the LTC workforce, research that seeks to understand what interventions are most effective for specific subgroups is desirable. Specific subgroups of interest include workers from communities of color; racial, ethnic, or sexual and gender groups; workers of lower socioeconomic status; and workers who experience health disparities. In addition, applications that seek to understand effective interventions for those workers exposed to misinformation about vaccinations is encouraged.
Efficacy and adaptation of existing interventions: PCORI is willing to consider studies that include comparators for which efficacy evidence has been generated in non-COVID contexts. We encourage the thoughtful adaptation of interventions currently in use to increase uptake of other vaccinations, including how to best tailor these interventions to workers of diverse racial, ethnic, and socioeconomic backgrounds or who have low health literacy.
Generating timely results: In considering the timeline and scope of their proposed study, applicants should bear in mind the importance of generating timely, relevant information for addressing the pandemic. PCORI strongly encourages applications that demonstrate readiness to produce preliminary results/outcomes within the first 12 months of the proposed study.
Potential collaborations: Applications may benefit from collaboration between researchers with expertise working in LTC settings and researchers with expertise in behavioral research concerning vaccine uptake. Applicants should demonstrate that members of their proposed study teams have expertise in these areas. Within the context of the COVID-19 pandemic, PCORI recognizes that forming and sustaining such relationships may be challenging and encourages the use of creative and flexible approaches that facilitate collaboration.
Download Full Announcement