A protocol for stakeholder engagement in deliver-EE: A pragmatic randomized comparative effectiveness trial evaluating effects of meal delivery on the ability of homebound older adults to remain in the community.

BACKGROUND: Few clinical trials include a detailed protocol for stakeholder engagement in the design and execution of the clinical trial. Deliver-EE is a pragmatic clinical trial to assess how different types of home-delivered meals can affect older adults' health and well-being. We present the protocol for stakeholder engagement in this national, multi-site trial and initial findings from our efforts. METHODS: Twenty-nine participants were recruited to two stakeholder advisory panels. The "Lived Experience Perspectives" panel is defined as the clients, caregivers, and meal delivery drivers with first-hand knowledge and lived experiences with meal delivery. The "System Perspectives" panel is defined as representatives from the larger financial, clinical, regulatory, and operational environments in which meal delivery to homebound older adults operate. Together, these two groups holistically represent interested parties that coordinate the interdependent elements of meal delivery to homebound older adults in order to: 1) inform our understanding of what matters most to older adults, their families, and the larger health and social care systems; 2) provide strategies to overcome challenges conducting the study; 3) enhance dissemination and uptake of study findings; and 4) identify opportunities for future research. RESULTS: Although stakeholder partners share a common goal of using home-delivered meals as a method to improve outcomes for homebound older adults, individuals have different goals for participating as advisors in this research. CONCLUSIONS: Understanding what individual stakeholders hope to gain from their participation is critical in designing an effective engagement protocol and critical for meaningful and rigorous stakeholder engagement in clinical trials.

Ca-HELP: Adaptation of a Communication Tool to Help Geriatric Cancer Patients in Rural Settings Talk to Their Doctors About Pain.

Background and Objectives: Among the older adult population living in the rural United States, undertreated cancer pain is very common. The need for interventions targeting pain management communication between older adults with cancer in rural communities and their doctors outpaces the current evidence base. Adaptation of existing pain interventions may improve the speed at which clinicians can respond to pain in this vulnerable population. Research Design and Methods: The Cancer Health Empowerment for Living without Pain (Ca-HELP) is an evidence-based communication tool that coaches patients to communicate about pain by asking questions, making requests, and signaling distress to their physicians in order to achieve improved pain control. Guided by the Method for Program Adaptation through Community Engagement (M-PACE) model, which utilizes detailed stakeholder feedback to guide the adaptation of an intervention for an appropriate target audience, we proactively adapted the Ca-HELP and its delivery for use among geriatric cancer patients living in rural settings using qualitative feedback from patients, informal caregivers, and providers as a planned step in a multiphase pilot study. Results: All stakeholders agreed that the Ca-HELP was a promising candidate intervention to improve pain among older adults with cancer. They suggested modifications to the delivery, context, and content of the intervention. A multidisciplinary team of nurse leaders and researchers evaluated stakeholder feedback and recommendations before determining which adaptations were made. Adaptations were cataloged and reported using the Framework for Reporting Adaptations and Modifications-Enhanced model. Discussion and Implications: Our multistakeholder team proactively modified the Ca-HELP intervention tool using end-user feedback with a goal to optimize fit for use by older adults with cancer in rural settings without compromising the active ingredients. Documenting and reporting modifications to interventions are critical to their implementation and will lay the groundwork for further testing of the efficacy of the adapted Ca-HELP intervention.

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

BACKGROUND: Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial. METHODS: 236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial. CONCLUSION: This pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.

Addressing hesitancy to COVID-19 vaccines in healthcare assistants.

COVID-19 vaccination rates have been suboptimal in frontline healthcare assistants (HCAs). We sought to characterize contributors to COVID-19 vaccine hesitancy among HCAs. We conducted an analysis of online survey responses from members of the National Association of Health Care Assistants from December 2020-January 2021. Respondents were asked what it would take for them to be vaccinated against COVID-19. Responses from 309 HCAs were coded to characterize respondents' willingness to be vaccinated and identify contributors to vaccine hesitancy. Approximately 60% (n = 185) of HCAs expressed hesitancy but would consider getting vaccinated under certain circumstances. We identified 8 overarching themes for contributors to COVID-19 vaccine hesitancy, the most common being safety concerns (70% of respondents). Others included efficacy (11.4%), workplace requirements (9.7%), societal influence (9.2%), and compensation (8.1%). Interventions to increase vaccine uptake among HCAs may be most effective by addressing concerns regarding the short-term and long-term safety implications of COVID-19 vaccines.

Evaluating the Findings of the IMPACT-C Randomized Clinical Trial to Improve COVID-19 Vaccine Coverage in Skilled Nursing Facilities.

IMPORTANCE: Identifying successful strategies to increase COVID-19 vaccination among skilled nursing facility (SNF) residents and staff is integral to preventing future outbreaks in a continually overwhelmed system. OBJECTIVE: To determine whether a multicomponent vaccine campaign would increase vaccine rates among SNF residents and staff. DESIGN, SETTING, AND PARTICIPANTS: This was a cluster randomized trial with a rapid timeline (December 2020-March 2021) coinciding with the Pharmacy Partnership Program (PPP). It included 133 SNFs in 4 health care systems across 16 states: 63 and 70 facilities in the intervention and control arms, respectively, and participants included 7496 long-stay residents (>100 days) and 17 963 staff. INTERVENTIONS: Multicomponent interventions were introduced at the facility level that included: (1) educational material and electronic messaging for staff; (2) town hall meetings with frontline staff (nurses, nurse aides, dietary, housekeeping); (3) messaging from community leaders; (4) gifts (eg, T-shirts) with socially concerned messaging; (5) use of a specialist to facilitate consent with residents' proxies; and (6) funds for additional COVID-19 testing of staff/residents. MAIN OUTCOMES AND MEASURES: The primary outcomes of this study were the proportion of residents (from electronic medical records) and staff (from facility logs) who received a COVID-19 vaccine (any), examined as 2 separate outcomes. Mixed-effects generalized linear models with a binomial distribution were used to compare outcomes between arms, using intent-to-treat approach. Race was examined as an effect modifier in the resident outcome model. RESULTS: Most facilities were for-profit (95; 71.4%), and 1973 (26.3%) of residents were Black. Among residents, 82.5% (95% CI, 81.2%-83.7%) were vaccinated in the intervention arm, compared with 79.8% (95% CI, 78.5%-81.0%) in the usual care arm (marginal difference 0.8%; 95% CI, -1.9% to 3.7%). Among staff, 49.5% (95% CI, 48.4%-50.6%) were vaccinated in the intervention arm, compared with 47.9% (95% CI, 46.9%-48.9%) in usual care arm (marginal difference: -0.4%; 95% CI, -4.2% to 3.1%). There was no association of race with the outcome among residents. CONCLUSIONS AND RELEVANCE: A multicomponent vaccine campaign did not have a significant effect on vaccination rates among SNF residents or staff. Among residents, vaccination rates were high. However, half the staff remained unvaccinated despite these efforts. Vaccination campaigns to target SNF staff will likely need to use additional approaches. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04732819.

Perceptions of COVID-19 vaccines among healthcare assistants: A national survey.

BACKGROUND: Limited COVID-19 vaccination acceptance among healthcare assistants (HCAs) may adversely impact older adults, who are at increased risk for severe COVID-19 infections. Our study objective was to evaluate the perceptions of COVID-19 vaccine safety and efficacy in a sample of frontline HCAs, overall and by race and ethnicity. METHODS: An online survey was conducted from December 2020 to January 2021 through national e-mail listserv and private Facebook page for the National Association of Health Care Assistants. Responses from 155 HCAs, including certified nursing assistants, home health aides, certified medical assistants, and certified medication technicians, were included. A 27-item survey asked questions about experiences and perceptions of COVID-19 vaccines, including how confident they were that COVID-19 vaccines are safe, effective, and adequately tested in people of color. Multivariable regression was used to identify associations with confidence in COVID-19 vaccines. RESULTS: We analyzed data from 155 completed responses. Among respondents, 23.9% were black and 8.4% Latino/a. Most respondents worked in the nursing home setting (53.5%), followed by hospitals (12.9%), assisted living (11.6%), and home care (10.3%). Respondents expressed low levels of confidence in COVID-19 vaccines, with fewer than 40% expressing at least moderate confidence in safety (38.1%), effectiveness (31.0%), or adequate testing in people of color (27.1%). Non-white respondents reported lower levels of confidence in adequate testing of vaccines compared to white respondents. In bivariate and adjusted models, respondents who gave more favorable scores of organizational leadership at their workplace expressed greater confidence in COVID-19 vaccines. CONCLUSION: Frontline HCAs reported low confidence in COVID-19 vaccines. Stronger organizational leadership in the workplace appears to be an important factor in influencing HCA's willingness to be vaccinated. Action is needed to enhance COVID-19 vaccine uptake in this important population with employers playing an important role to build vaccine confidence and trust among employees.

"Somebody Like Me": Understanding COVID-19 Vaccine Hesitancy among Staff in Skilled Nursing Facilities.

OBJECTIVE: The vaccination of skilled nursing facility (SNF) staff is a critical component in the battle against COVID-19. Together, residents and staff constitute the single most vulnerable population in the pandemic. The health of these workers is completely entangled with the health of those they care for. Vaccination of SNF staff is key to increasing uptake of the vaccine, reducing health disparities, and reopening SNFs to visitors. Yet, as the vaccine rollout begins, some SNF staff are declining to be vaccinated. The purpose of this article is to describe reasons for COVID-19 vaccine hesitancy reported by staff of skilled nursing facilities and understand factors that could potentially reduce hesitancy. DESIGN: Five virtual focus groups were conducted with staff of SNFs as part of a larger project to improve vaccine uptake. SETTING AND PARTICIPANTS: Focus groups with 58 staff members were conducted virtually using Zoom. MEASURES: Focus groups sought to elicit concerns, perspectives, and experiences related to COVID-19 testing and vaccination. RESULTS: Our findings indicate that some SNF staff are hesitant to receive the COVID-19 vaccine. Reasons for this hesitancy include beliefs that the vaccine has been developed too fast and without sufficient testing; personal fears about pre-existing medical conditions, and more general distrust of the government. CONCLUSIONS AND IMPLICATIONS: SNF staff indicate that seeing people like themselves receive the vaccination is more important than seeing public figures. We discuss the vaccination effort as a social enterprise and the need to develop long-term care provider-academic-community partnerships in response to COVID-19 and in expectation of future pandemics.

Reflections on the IJHPR's article collection on dementia.

Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) constitute a worldwide public health crisis. In light of the AD/ADRD epidemic now existing within the global COVID-19 pandemic, the need for global action to improve dementia care is greater than ever. The article collection "Dementia- an Interdisciplinary Approach," in the Israeli Journal of Health Policy and Research (IJHPR) highlights the need for interprofessional approaches to improving outcomes for people living with dementia and their care partners, as well as the complexities of conducting dementia care research.

Engaging Stakeholders in the Design and Conduct of Embedded Pragmatic Clinical Trials for Alzheimer's Disease and Alzheimer's Disease-Related Dementias.

Embedded pragmatic clinical trials (ePCTs) of nondrug interventions for Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD) are conducted in real-world clinical settings and designed to generate an evidence base to inform clinical and policy decisions about care for this vulnerable population. The ePCTs exist within a complex ecosystem of relationships between researchers, payors, policymakers, healthcare systems, direct care staff, advocacy groups, families, caregivers, and people living with dementia (PLWD). Because the rapid increase of the number of Americans with AD/ADRD outpaces curative treatments, there is an urgent need to mobilize the power of these relationships to improve dementia care and address a mounting public health crisis. Stakeholder engagement in ePCTs is essential to generate research questions, establish the relevancy of trials to the intended end users, and understand the factors that influence dissemination and implementation in real-world clinical settings. The process of including stakeholders in ePCTs for dementia is similar to stakeholder engagement in ePCTs for other diseases and conditions; however, the unique nature of embedded research, prevalence of caregiver and provider burden, and the progressive worsening of cognitive impairment in PLWD must be approached with additional strategies. This article presents key considerations of stakeholder engagement for ePCTs in AD/ADRD and main activities of the stakeholder engagement team in the National Institute on Aging IMPACT Collaboratory to move the field forward. J Am Geriatr Soc 68:S62-S67, 2020.

Embedded Pragmatic Trials in Dementia Care: Realizing the Vision of the NIA IMPACT Collaboratory.

Close to 6 million Americans have Alzheimer's disease (AD) or Alzheimer's disease and related dementia (AD/ADRD). These high-need, high-cost patients are vulnerable to receiving poor quality uncoordinated care, ultimately leading to adverse health outcomes, poor quality of life, and misuse of resources. Improving the care of persons living with dementia (PLWD) and their caregivers is an urgent public health challenge that must be informed by high-quality evidence. Although prior research has elucidated opportunities to improve AD/ADRD care, the adoption of promising interventions has been stymied by the lack of research evaluating their effectiveness when implemented under real-world conditions. Embedded pragmatic clinical trials (ePCTs) in healthcare systems have the potential to accelerate the translation of evidence-based interventions into clinical practice. Building from the foundation of the National Institutes of Healthcare Systems Collaboratory, in September 2019 the National Institute on Aging Imbedded Pragmatic AD/ADRD Clinical Trials (IMPACT) Collaboratory was launched. Its mission is to build the nation's capacity to conduct ePCTs within healthcare systems for PLWD and their caregivers by (1) developing and disseminating best practice research methods, (2) supporting the design and conduct of ePCTs including pilot studies, (3) building investigator capacity through training and knowledge generation, (4) catalyzing collaboration among stakeholders, and (5) ensuring the research includes culturally tailored interventions for people from diverse backgrounds. This report presents the rationale, structure, key activities, and markers of success for the overall NIA IMPACT Collaboratory. The articles that follow in this special Issue describe the specific work of its 10 core working groups and teams. J Am Geriatr Soc 68:S1-S7, 2020.

Barriers to a Timely Discharge From Short-Term Care in VA Community Living Centers.

This study aimed to identify the barriers to a timely discharge from short-term care in Veterans Health Administration (VHA) Community Living Centers (CLCs). Ninety-nine interviews were conducted with CLC staff in leadership and direct-care positions in eight varied CLCs. Major themes identified through qualitative analysis as barriers to a timely discharge were a lack of patients' financial resources, low social support, and reluctance of some veterans and staff to view a timely veteran discharge as their goal. Staff also perceived that barriers were much more difficult to overcome in regions where community-based long-term services and supports were limited or nonexistent. Because VHA has lagged behind Medicaid more generally in terms of investment in these types of services, additional strategies are warranted to achieve the important policy goal of deinstitutionalizing VHA care and returning veterans to their homes in the community.

The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

History of US Presidential Assaults on Modern Environmental Health Protection.

The Trump administration has undertaken an assault on the Environmental Protection Agency (EPA), an agency critical to environmental health. This assault has precedents in the administrations of Ronald Reagan and George W. Bush. The early Reagan administration (1981-1983) launched an overt attack on the EPA, combining deregulation with budget and staff cuts, whereas the George W. Bush administration (2001-2008) adopted a subtler approach, undermining science-based policy. The current administration combines both these strategies and operates in a political context more favorable to its designs on the EPA. The Republican Party has shifted right and now controls the executive branch and both chambers of Congress. Wealthy donors, think tanks, and fossil fuel and chemical industries have become more influential in pushing deregulation. Among the public, political polarization has increased, the environment has become a partisan issue, and science and the mainstream media are distrusted. For these reasons, the effects of today's ongoing regulatory delays, rollbacks, and staff cuts may well surpass those of the administrations of Reagan and Bush, whose impacts on environmental health were considerable.

Beliefs and Behaviors of Pregnant Women with Addictions Awaiting Treatment Initiation.

Substance use during pregnancy poses clear risks to children's healthy development. However, women with addictions face unique barriers to accessing substance abuse treatment and often delay or avoid treatment seeking. The objective of this study was to examine women's beliefs about the impact of use on the developing baby and to examine the protective behaviors that women with addictions engage in during the period of time between when they first find out they are pregnant and when they begin substance abuse treatment. Semi-structured interviews were conducted with 15 women who were either pregnant or postpartum and who had used illicit substances during pregnancy. All participants were currently receiving inpatient substance abuse treatment services to address their addiction and were asked to retrospectively report on their experiences. Interviews were transcribed, imported into a qualitative data analysis software, and iteratively coded for themes. Women reported being concerned about the impact of substance use on the developing baby, in particular, about the physical and long-term developmental consequences of prenatal exposure. Given these concerns, women described trying to protect the baby from harm on their own, outside of accessing traditional treatment services. They sought information anonymously, increased their engagement in health-promoting behaviors, and decreased their use of alcohol and other drugs. The results suggest that women who use alcohol and other drugs during pregnancy are often motivated to protect their baby from harm and are engaging in harm reduction behaviors prior to accessing treatment services.

Resident-Centered Care in 10 U.S. Nursing Homes: Residents' Perspectives.

PURPOSE: With increased focus on resident-centered care (RCC) as an organizational imperative and a guiding principle of culture change for long-term care communities, evaluation of its success has centered primarily on the organizational perspective. METHODS: For this case report, we examine resident perspectives of RCC in 10 nursing homes across the United States that had adopted RCC as a philosophy and model of care for at least 12 months with a maximum engagement of 3 years using a phenomenological approach. FINDINGS: Qualitative findings from 20 focus groups with residents in 10 nursing homes suggest that RCC has meaning in ways that are consistent with intentions at the national and state levels to advance culture change in nursing homes, including efforts to create a more homelike environment, increase resident decision making and direction of his or her lifestyle, and put residents first. CLINICAL RELEVANCE: Residents attribute increased choice in wake and bed times, being heard by organizational leaders, and consistent staff assignment as positive changes since RCC began. However, according to residents, aspects of institutional life in nursing homes, inconsistent with RCC, remain. Residents identified three areas of improvement that would make nursing homes more resident centered. The three areas are response time, access to nature, and transparency about illness and death in the community.

An Unintended Consequence of Culture Change in VA Community Living Centers.

OBJECTIVE: Although a growing body of evidence suggests that culture change and its corollary, person-centered care improves resident outcomes in the nursing home setting, little is known about the effect of culture change in a postacute setting in which patients receive skilled nursing and rehabilitation services for a relatively short period of time before returning home. DESIGN: Data for this study were collected as part of a larger project to understand the impact of Veterans Health Administration (VHA) policies to shift the mission of VHA Community Living Centers (CLCs) from long-stay custodial care to short-stay skilled nursing and rehabilitative care. RESULTS: Although qualitative data collected during interviews from site visits to eight geographically diverse CLCs suggest an increase in the quality of life and care for veterans, interview data also indicate an unintended consequence. Specifically, staff described how aspects of the homelike environment, relationship-based care delivery, and attention to veterans' preferences that characterize culture change can prolong a veteran's length of stay beyond treatment completion. In addition to providing skilled nursing and rehabilitation, VHA CLCs also serve a latent function of providing a comfortable home and a peer community for veterans to connect and socialize with one another. A congregate living environment for persons with the shared symbolic status of being a veteran is unique to VHA CLCs. Strong bonding among peers and staff as well as staff respect for veterans' service to the country may increase their sense of obligation to keep veterans past their expected discharge date. CONCLUSION: Our findings suggest that the complexities of culture change and veteran- centered care in a short-term care setting may be underrecognized. We discuss how findings may also be relevant for the non-VHA sector.

Two useful tools: to improve patient engagement and transition from the hospital.

We use an Internet-based health assessment and feedback system to examine the range of needs and diverse experiences of 520 hospitalized adults in transition and the factors most strongly associated with their self-reported health confidence. Our results strongly suggest that patient engagement prior to admission and the quality of care coordination and communication during hospitalization can greatly enhance successful transition from the hospital back to the community. Hospitals are complex institutions. This report illustrates how the Internet or a straightforward graphic can make the complexity less overwhelming to patients and efficiently increase their health confidence for transitions.