Efforts to Support the Mental Health and Well-being of Nursing Home Staff: Insights From Leaders.

OBJECTIVES: The sustained stress and trauma experienced by frontline nursing home (NH) staff throughout the COVID-19 pandemic has been described in health care literature and popular press. Yet, limited attention has been given to attempts to support NH staff. The objective of this study was to examine efforts to support the mental health and well-being of NH staff during the COVID-19 pandemic. DESIGN: Qualitative, multiple-case-study design that purposively sampled NHs from 3 groups based on the Centers for Medicare & Medicaid Services NH 5-star quality performance ratings [ie, high (4-5-star), medium (3-star), and low (1-2-star)]. SETTINGS AND PARTICIPANTS: Ninety-four US NH leaders participated in semistructured interviews via phone, between January 2021 and December 2022. METHODS: A 3-step rapid qualitative analysis process was used to conduct a thematic analysis. RESULTS: Five themes emerged as NH leaders described strategies used to address the mental health and well-being of their staff, including (1) efforts to address stressors in staff's personal lives (eg, risk of COVID-19 transmission to families, finances), (2) providing mental health services (eg, counseling, Employee Assistance Program) and resources (eg, staff self-care, mindfulness), (3) appreciation initiatives to combat negative media portrayals of NHs, (4) fostering an environment that supports mental health and well-being (eg, leadership initiatives to prioritize mental health, embedding training on burnout into standing meetings), and (4) modifying staff benefits (eg, expanding mental health coverage within staff insurance plan, paid time off). CONCLUSIONS: In light of concerns about NH staffing levels and the recently proposed minimum staffing levels, there is a need to design and evaluate initiatives to recruit and retain qualified NH staff. Insights into efforts implemented by NH leaders to improve mental health and well-being can inform the design of future efforts to improve staff retention.

The Relationship between Nursing Home Staffing and Health Outcomes Revisited.

OBJECTIVE: Nursing homes make staffing decisions in conjunction with choosing quality goals, potentially leading to endogeneity bias between staffing and quality. We use instrumental variables (IVs) to explore it. DESIGN: Retrospective statistical analysis of 2017-2019 Payroll-Based Journal, Minimum Data Set, Nursing Home Care Compare, and Long-Term Care Focus. SETTINGS AND PARTICIPANTS: A total of 11,261 nursing homes nationally. METHODS: We estimated separate models for each of 6 quality measures as dependent variables, and registered nurses (RNs), certified nurse assistants (CNAs), and licensed practical nurses (LPNs) as independent variables, including other control variables associated with quality. The models were estimated using both ordinary least squares (OLS) and 2-stage least squares (2SLS) methods, the latter accounting for endogeneity. The IVs were defined as the average staffing of competing nursing homes in the same market as the index facility. RESULTS: Estimated coefficients for the quality measures in the 2SLS models were up to 5 times larger than in the OLS models. The 2SLS estimates for antipsychotic medications use increased with higher RN staffing [0.279 (0.004 to 0.553)] and decreased with higher CNAs [-0.125 (-0.198 to -0.052)]. Hospitalizations decreased with more RNs [-1.328 (-1.673 to -0.983)] and LPN staffing [-0.483 (-0.755 to -0.211])] and increased with CNA [0.201 (0.109 to 0.293)] staffing. Emergency room visits decreased with higher RNs [-1.098 (-1.500 to -0.696)] and increased with CNAs [0.191 (0.084 to 0.298)]. Long-stay activities of daily living [-0.313 (-0.416 to -0.209)] and short-stay functioning [-0.481 (-0.598 to -0.364)] improved only with higher CNA staffing and pressure sores improved only with increased RN staffing [-0.436 (-0.836 to -0.035)]. CONCLUSIONS AND IMPLICATIONS: Our findings demonstrate the importance of accounting for endogeneity in studies of staffing and quality. Endogeneity changes conclusions about significance, direction, and magnitude of the relationship between staffing and specific quality measures. These findings highlight the need to further study and understand the nuanced relationship between different staffing types and different health outcomes such as the difference between the relationship of RN and CNA hours per resident day to antipsychotic quality measures.

Skilled nursing facility staffing shortages: Sources, strategies, and impacts on staff who stayed.

OBJECTIVE: To examine skilled nursing facility (SNF) staffing shortages across job roles during the COVID-19 pandemic. We aimed to capture the perspectives of leaders on the breadth of staffing shortages and their implications on staff that stayed throughout the pandemic in order to provide recommendations for policies and practices used to strengthen the SNF workforce moving forward. STUDY SETTING AND DESIGN: For this qualitative study, we engaged a purposive national sample of SNF leaders (n = 94) in one-on-one interviews between January 2021 and December 2022. DATA SOURCE AND ANALYTIC SAMPLE: Using purposive sampling (i.e., Centers for Medicare & Medicaid quality rating, region, ownership) to capture variation in SNF organizations, we conducted in-depth, semi-structured qualitative interviews, guided a priori by the Institute of Medicine's Model of Healthcare System Framework. Interviews were conducted via phone, audio-recorded, and transcribed. Rigorous rapid qualitative analysis was used to identify emergent themes, patterns, and relationships. PRINCIPAL FINDINGS: SNF leaders consistently described staffing shortages spanning all job roles, including direct care (e.g., activities, nursing, social services), support services (e.g., laundry, food, environmental services), administrative staff, and leadership. Ascribed sources of shortages were multidimensional (e.g., competing salaries, family caregiving needs, burnout). The impact of shortages was felt by all staff that stayed. In addition to existing job duties, those remaining staff experienced re-distribution of essential day-to-day operational tasks (e.g., laundry) and allocation of new COVID-19 pandemic-related activities (e.g., screening). Cross-training was used to cover a wide range of job duties, including patient care. CONCLUSIONS: Policies are needed to support SNF staff across roles beyond direct care staff. These policies must address the system-wide drivers perpetuating staffing shortages (i.e., pay differentials, burnout) and leverage strategies (i.e., cross-training, job role flexibility) that emerged from the pandemic to ensure a sustainable SNF workforce that can meet patient needs.

Which medicare advantage enrollees are at highest one-year mortality risk?

BACKGROUND: While a number of tools exist to predict mortality among older adults, less research has described the characteristics of Medicare Advantage (MA) enrollees at higher risk for 1 year mortality. OBJECTIVES: To describe the characteristics of MA enrollees at higher mortality risk using patient survey data. RESEARCH DESIGN: Retrospective cohort. SUBJECTS: MA enrollees completing the 2019 MA Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey. MEASURES: Linked demographic, health, and mortality data from a sample of MA enrollees were used to predict 1-year mortality risk and describe enrollee characteristics across levels of predicted mortality risk. RESULTS: The mortality model had a 0.80 c-statistic. Mortality risks were skewed: 6 % of enrollees had a ≥ 10 % 1-year mortality risk, while 45 % of enrollees had 1 % to < 5 % 1-year mortality risk. Among the high-risk (≥10 %) group, 47 % were age 85+ versus 12 % among those with mortality risk <5 %. 79 % were in fair or poor self-rated health versus 29 % among those with mortality risk of <5 %. 71 % reported needing urgent care in the prior 6 months versus 40 % among those with a mortality risk of 1 to<5 %. CONCLUSIONS: Relatively few older adults enrolled in MA are at high 1-year mortality risk. Nonetheless, MA enrollees over age 85, in fair or poor health, or with recent urgent care needs are far more likely to be in a high mortality risk group.

Assessing the accuracy of race-and-ethnicity data in the Outcome and Assessment Information Set.

BACKGROUND: Limitations in the quality of race-and-ethnicity information in Medicare's data systems constrain efforts to assess disparities in care among older Americans. Using demographic information from standardized patient assessments may be an efficient way to enhance the accuracy and completeness of race-and-ethnicity information in Medicare's data systems, but it is critical to first establish the accuracy of these data as they may be prone to inaccurate observer-reported or third-party-based information. This study evaluates the accuracy of patient-level race-and-ethnicity information included in the Outcome and Assessment Information Set (OASIS) submitted by home health agencies. METHODS: We compared 2017-2022 OASIS-D race-and-ethnicity data to gold-standard self-reported information from the Medicare Consumer Assessment of Healthcare Providers and Systems® survey in a matched sample of 304,804 people with Medicare coverage. We also compared OASIS data to indirect estimates of race-and-ethnicity generated using the Medicare Bayesian Improved Surname and Geocoding (MBISG) 2.1.1 method and to existing Centers for Medicare & Medicaid Services (CMS) administrative records. RESULTS: Compared with existing CMS administrative data, OASIS data are far more accurate for Hispanic, Asian American and Native Hawaiian or other Pacific Islander, and White race-and-ethnicity; slightly less accurate for American Indian or Alaska Native race-and-ethnicity; and similarly accurate for Black race-and-ethnicity. However, MBISG 2.1.1 accuracy exceeds that of both OASIS and CMS administrative data for every racial-and-ethnic category. Patterns of inconsistent reporting of racial-and-ethnic information among people for whom there were multiple observations in the OASIS and Consumer Assessment of Healthcare Providers and Systems (CAHPS) datasets suggest that some of the inaccuracies in OASIS data may result from observation-based reporting that lessens correspondence with self-reported data. CONCLUSIONS: When health record data on race-and-ethnicity includes observer-reported information, it can be less accurate than both true self-report and a high-performing imputation approach. Efforts are needed to encourage collection of true self-reported data and explicit record-level data on the source of race-and-ethnicity information.

Differential associations of mask mandates on COVID-19 infection and mortality by community social vulnerability.

BACKGROUND: The COVID-19 pandemic in the United States has disproportionately impacted communities deemed vulnerable to disease outbreaks. Our objectives were to test (1) whether infection and mortality decreased in counties in the most vulnerable (highest) tercile of the Social Vulnerability Index (SVI), and (2) whether disparities between terciles of SVI were reduced, as the length of mask mandates increased. METHODS: Using the New York Times COVID-19 and the Centers for Disease Control and Prevention SVI and mask mandate datasets, we conducted negative binomial regression analyses of county-level COVID-19 cases and deaths from 1/2020-11/2021 on interactions of SVI and mask mandate durations. RESULTS: Mask mandates were associated with decreases in mid-SVI cases (IRR: 0.79) and deaths (IRR: 0.90) and high-SVI cases (IRR: 0.89) and deaths (IRR: 0.88). Mandates were associated with the mitigation of infection disparities (Change in IRR: 0.92) and mortality disparities (Change in IRR: 0.85) between low and mid-SVI counties and mortality disparities between low and high-SVI counties (Change in IRR: 0.84). DISCUSSION: Mask mandates were associated with reductions in COVID-19 infection and mortality and mitigation of disparities for mid and high-vulnerability communities. CONCLUSIONS: Ongoing COVID-19 response efforts may benefit from longer-standing infection control policies, particularly in the most vulnerable communities.

COVID-19 Infection and Mortality in State Veterans Homes: A Multilevel Approach.

OBJECTIVES: Some state veterans homes (SVHs) received media attention in the wake of the COVID-19 pandemic because of allegations of poor infection control and excess mortality. However, little research has investigated how these facilities differ from community nursing homes (CNHs) and what the geographical trends of these infection and mortality differences are. We aimed to test (1) whether infection was overall lower in SVHs than CNHs, (2) whether mortality was overall lower in SVHs than CNHs, as well as the geographic distribution of nursing home infection and mortality across the United States. DESIGN: Retrospective nationwide cohort study. SETTING AND PARTICIPANTS: Skilled nursing facilities in the United States from May 2020 to July 2022 during the COVID-19 pandemic. METHODS: Using multilevel negative binomial regression, we modeled COVID-19 infection and mortality rates in skilled nursing homes, testing for overall SVH differences from May 2020 to July 2022, placing random effects on counties to calculate adjusted county-level infection and mortality rates. RESULTS: SVHs experienced 18% fewer cases but 25% more deaths overall compared with CNHs. Counties with the highest levels of facility infection, including counties with SVHs, were situated mainly in Midwestern, Atlantic, and Southern states, with the majority of counties with low infection levels in Central and Western states. Counties with the highest levels of facility mortality emerged in Rust Belt and Midwestern states down to Southern states, with the lowest levels of county-level mortality, particularly among counties containing SVHs, occurring westward to Central and Western states. CONCLUSION AND IMPLICATIONS: SVHs experienced lower infection levels but higher mortality levels than CNHs, and fewer extremely high infection and mortality rates in counties containing SVHs despite higher mortality risk in SVHs, calling attention to unobserved facility-level differences such as gender and age distributions and future research opportunities using more granular geographical aggregations to better understand facility-level SVH risk within the broader neighborhood context.

Changes in Site of Death Among Older Adults Without a COVID-19 Diagnosis During the COVID-19 Pandemic.

BACKGROUND: Understanding how the coronavirus disease 2019 (COVID-19) pandemic affected site of death-an important patient-centered outcome related to end-of-life care-would inform healthcare system resiliency in future public health emergencies. OBJECTIVE: To evaluate the changes in site of death during the COVID-19 pandemic among older adults without a COVID-19 diagnosis. DESIGN: Using a quasi-experimental difference-in-differences method, we estimated net changes in site of death during the pandemic period (March-December 2020) from the pre-pandemic period (January-February 2020), using data on the same months in prior years (2016-2019) as the control. PARTICIPANTS: A 20% sample of Medicare Fee-for-Service beneficiaries aged 66 years and older who died in 2016-2020. We excluded beneficiaries with a hospital diagnosis of COVID-19. MAIN MEASURES: We assessed each of the following sites of death separately: (1) home or community; (2) acute care hospital; and (3) nursing home. KEY RESULTS: We included 1,133,273 beneficiaries without a hospital diagnosis of COVID-19. We found that the proportion of Medicare beneficiaries who died at home or in the community setting increased (difference-in-differences [DID] estimate, + 3.1 percentage points [pp]; 95% CI, + 2.6 to + 3.6 pp; P < 0.001) and the proportion of beneficiaries who died (without COVID-19 diagnosis) in an acute care hospital decreased (- 0.8 pp; 95% CI, - 1.2 to - 0.4 pp; P < 0.001) during the pandemic. We found no evidence that the proportion of deaths in nursing homes changed during the pandemic. CONCLUSIONS: Using national data on older adults without a COVID-19 diagnosis, we found that site of death shifted toward home or community settings during the COVID-19 pandemic. Our findings may inform clinicians and policymakers in supporting end-of-life care during future public health emergencies.

Selecting outcomes for pragmatic clinical trials in dementia care: The IMPACT Collaboratory iLibrary.

BACKGROUND: Many interventions improve care and outcomes for people with Alzheimer's Disease and related dementias (ADRD), yet are never disseminated. Pragmatic trials facilitate the adoption and dissemination of best practices, but gaps in pragmatic outcome measurement are a critical obstacle. Our objectives are (1) to describe the development and structure of the IMbedded Pragmatic ADRD Clinical Trials Collaboratory (IMPACT) iLibrary of potential outcome measures for ADRD pragmatic trials, and (2) to assess their pragmatic characteristics. METHODS: We identified potential outcome measures from several sources: a database of administrative and clinical outcome measures from ADRD clinical trials registered in ClinicalTrials.gov, published reviews, and IMPACT pilot pragmatic trial outcome measures. The iLibrary reports (a) number of items, (b) completion time, (c) readability for diverse populations, (d) cost or copyright barriers to use, (e) method of administration, (f) assessor training burden, and (g) feasibility of data capture and interpretation in routine care; a summary of pragmatic characteristics of each outcome measure (high, moderate, low); items or descriptions of items; and links to primary citations regarding development or psychometric properties. RESULTS: We included 140 outcome measures in the iLibrary: 66 administrative (100% were pragmatic) and 74 clinical (52% were pragmatic). The most commonly addressed outcome domains from administrative assessments included physical function, quality of care or communication concerns, and psychological symptoms or distress behaviors. The most commonly addressed outcome domains from clinical assessments were psychological symptoms or distress behaviors, physical function, cognitive function, and health-related quality of life. CONCLUSIONS: Pragmatic outcome measures are brief, meaningful to diverse populations, easily scored and interpreted by clinicians, and available in electronic format for analysis. The iLibrary can facilitate the selection of measures for a wide range of outcomes relevant to people with ADRD and their care partners.

Focusing on Provider Quality Measurement: Continued Consensus and Feasibility Testing of Practice-Based Quality Measures for Primary Care Providers in Long-Term Care.

Medical providers in long-term care (LTC) use a unique skillset in delivering comprehensive resident care. Publicly reported quality measures (QMs) do not directly emphasize medical provider competency and their role in care. The impact of providers is understudied and to a large extent, unknown. Our objective was to define, test, and validate QMs to pragmatically measure the practice-based quality of medical providers in a pilot study. We included 7 North American LTC homes with data from practicing medical providers for LTC residents. We engaged in a 4-phased approach. In phase 1, experts rated 95 candidate QMs using 5 pragmatic-focused criteria in a RAND-modified Delphi process. Phase 2 involved specifying 37 QMs for collection (4 QMs were dropped during pilot testing). We created an abstraction manual and data collection tool for all QMs. Phase 3 involved a retrospective chart review in 7 LTC homes on 33 QMs with trained data abstractors. Data were sufficient to analyze performance for 26 QMs. Lastly, in phase 4 results and psychometric properties were reviewed with an expert panel. They ranked the tested measures for validity and feasibility for use by a nonphysician auditor to evaluate medical provider performance based on medical record review. In total, we examined data from 343 resident charts from 7 LTC homes and 49 providers. Our process yielded 10 QMs as being specified for measurement, feasible to collect, and had good test performance. This is the only study to systematically identify a subset of QMs for feasible collection from the medical record by various data collectors. This pragmatic approach to measuring practice-based quality and quantifying select medical provider competencies allows for the evaluation of individual and facility-level performance and facilitates quality improvement initiatives. Future work should perform broader testing and validate and refine operationalized QMs.

Dementia, nurse staffing, and health outcomes in nursing homes.

OBJECTIVE: To estimate and contrast the relationships between nurse staffing and health outcomes in nursing homes with low and high dementia census, to understand the association of staffing hours with dementia care quality. DATA SOURCES AND STUDY SETTING: A national sample of nursing homes during 2017-2019 (pre-COVID). Data included the Payroll-Based Journal, Medicare Claims, Nursing Home Care Compare, and Long-Term Care Focus. STUDY DESIGN: Retrospective, regression analyses. We estimated separate linear models predicting six long-term facility-level outcomes. Independent variables included staffing hours per resident-day (HPRD) interacted with the facility percentage of dementia residents, controlling for other resident and facility characteristics. DATA COLLECTION/EXTRACTION METHODS: Hospital-based nursing homes, those with fewer than 30% dementia residents, and missing data were excluded. PRINCIPAL FINDINGS: We found that registered nurses and certified nurse assistants HPRDs were likely to exhibit positive returns in terms of outcomes throughout most of the range of HPRD for both high and low-census dementia facilities, although, high- and low-dementia facilities differed in most outcome rates at all staffing levels. Average predicted antipsychotics and activities of daily living as functions of HPRD were worse in higher dementia facilities, independent movement, and hospitalizations did not differ significantly, and Emergency Rooms and pressure sores were worse in lower dementia facilities. Average marginal effects were not statistically different [CI included zero] between the high and low dementia facilities for any outcome. CONCLUSIONS: These findings suggest that increasing staffing will improve outcomes by similar increments in both low- and high-dementia facilities for all outcomes. However, at any given level of staffing, absolute differences in outcomes between low- and high-dementia facilities remain, suggesting that additional staffing alone will not suffice to close these gaps. Further studies are required to identify opportunities for improvement in performance for both low- and high-dementia census facilities.

Implementation of US Post-Acute Care Payment Reform and COVID-19 Policies: Examining Experiences of Health System Leaders, Staff, Patients, and Family Caregivers-A Protocol.

In fiscal year 2020, new national Medicare payment models were implemented in the two most common post-acute care settings (i.e., skilled nursing facilities (SNFs) and home health agencies (HHAs)), which were followed by the emergence of COVID-19. Given concerns about the unintended consequence of these events, this study protocol will examine how organizations responded to these policies and whether there were changes in SNF and HHA access, care delivery, and outcomes from the perspectives of leadership, staff, patients, and families. We will conduct a two-phase multiple case study guided by the Institute of Medicine's Model of Healthcare Systems. Phase I will include three cases for each setting and a maximum of fifty administrators per case. Phase II will include a subset of Phase I organizations, which are grouped into three setting-specific cases. Each Phase II case will include a maximum of four organizations. Semi-structured interviews will explore the perspectives of frontline staff, patients, and family caregivers (Phase II). Thematic analysis will be used to examine the impact of payment policy and COVID-19 on organizational operations, care delivery, and patient outcomes. The results of this study intend to develop evidence addressing concerns about the unintended consequences of the PAC payment policy during the COVID-19 pandemic.

Dementia Care Is Widespread In US Nursing Homes; Facilities With The Most Dementia Patients May Offer Better Care.

More than three million US nursing home residents were diagnosed with Alzheimer's disease and related dementias (ADRD) between 2017 and 2019. This number is expected to increase as the population ages and ADRD prevalence increases. People with ADRD require specialized care from trained staff. This study addressed two questions: Are residents with ADRD concentrated in nursing homes where they are the majority? If not, what are the implications for their quality of care and life? We answered the first question by determining the ADRD census for each nursing home in the country during the period 2017-19. Using the Minimum Data Set and Medicare claims, we compared characteristics of nursing homes with high and low ADRD census along several dimensions, including staffing, resident outcomes, and resident characteristics. We found that residents with ADRD were dispersed throughout all nursing homes, with fewer than half residing in nursing homes where residents with ADRD accounted for 60-90 percent of the census. Furthermore, only facilities exceeding 90 percent of residents with ADRD seemed to offer better care. These findings raise concerns about the quality of care and life for the majority of residents with ADRD, suggesting that current National Institutes of Health dementia research initiatives and the Biden administration's policies to improve nursing home care should be coordinated.

New Dimensions of Staffing Patterns in Nursing Homes and Nursing Home Quality: Comparing Staffing Instability to Staffing Turnover.

OBJECTIVE: This study examines how measures of staffing-turnover and instability-are associated with one another and how they independently contribute to quality of care in nursing homes. DESIGN: Cross-sectional analysis of 2021-2022 administrative data. Data included the Payroll Based Journal for daily staffing information, merged with Nursing Home Care Compare (NHCC) data for nursing home characteristics, total staffing turnover, and nursing home quality. SETTING AND PARTICIPANTS: A total of 11,840 nursing homes nationally reporting data on daily staffing and staffing turnover. METHODS: We explored correlations between measures of staffing and estimated facility-level regression models with robust standard errors. The dependent variables were indicators of nursing home quality included in the NHCC 5-star ratings. The independent variables of interest were average total staffing hours per resident-day, total staffing turnover, and total staffing instability. RESULTS: For the 11,840 nursing homes in the study, there was a weak positive correlation between turnover and instability, with some overlap between nursing homes with high instability and high turnover. Regression analysis revealed that staffing instability and turnover contributed independently to nursing home quality, with instability having a stronger association with some measures of quality and turnover with others. Staffing instability was positively and more strongly associated with long-stay residents' decline in activities of daily living levels and receipt of antipsychotic drugs and short-stay residents' functioning at discharge. Turnover was positively and more strongly associated with long-stay residents' prevalence of pressure ulcers and worsening mobility, and short-stay residents' hospitalizations. CONCLUSION AND IMPLICATIONS: Instability and turnover in total nursing home staffing independently contribute to nursing home quality. This suggests that adding measures of staffing instability to the existing measures of average staffing and staff turnover in NHCC may enhance the report card's value for providers engaged in quality improvement and consumers searching for high-quality nursing homes.

Barriers and Facilitators to Home- and Community-Based Services Access for Persons With Dementia and Their Caregivers.

OBJECTIVES: The United States has seen increasing shifts toward home- and community-based services (HCBS) in place of institutional care for long-term services and supports. However, research has neglected to assess whether these shifts have improved access to HCBS for persons with dementia. This paper identifies HCBS access barriers and facilitators, and discusses how barriers contribute to disparities for persons with dementia living in rural areas and exacerbate disparities for minoritized populations. METHODS: We analyzed qualitative data from 35 in-depth interviews. Interviews were held with stakeholders in the HCBS ecosystem, including Medicaid administrators, advocates for persons with dementia and caregivers, and HCBS providers. RESULTS: Barriers to HCBS access for persons with dementia range from community and infrastructure barriers (e.g., clinicians and cultural differences), to interpersonal and individual-level barriers (e.g., caregivers, awareness, and attitudes). These barriers affect the health and quality of life for persons with dementia and may affect whether individuals can remain in their home or community. Facilitators included a range of more comprehensive and dementia-attuned practices and services in health care, technology, recognition and support for family caregivers, and culturally competent and linguistically accessible education and services. DISCUSSION: System refinements, such as incentivizing cognitive screening, can improve detection and increase access to HCBS. Disparities in HCBS access experienced by minoritized persons with dementia may be addressed through culturally competent awareness campaigns and policies that recognize the necessity of familial caregivers in supporting persons with dementia. These findings can inform efforts to ensure more equitable access to HCBS, improve dementia competence, and reduce disparities.

Protecting seriously ill populations during pragmatic clinical trials.

Pragmatic clinical trials (PCTs) emphasize real-world effectiveness methodology to address the limitations of results from explanatory randomized clinical trials (RCTs), which often fail to translate to real-world medical practice. An inherent tension in the conduct of PCTs is that the research must impose a minimal burden on patients and health care institutions. PCTs prioritize outcome measures from existing data sources to minimize data collection burden; however, a lack of patient-reported outcomes may result in gaps in safety for vulnerable populations, such as those with serious illnesses. One proposed standard for judging the readiness of a study for a pragmatic trial is a ranking system that assigns PCTs a lower rank if they impose additional data collection burdens. However, this results in the wide use of measures of health care utilization and costs while patient experience measures, which could capture adverse unintended consequences, are omitted. In this article, we make the case for a risk-based approach to imposing additional data collection in PCTs to capture potential safety and patient experience outcomes, using examples from "real life" implemented interventions to improve end-of-life care through the Liverpool Pathway and through the implementation of Physician Orders for Life Sustaining Treatment (POLST) in Oregon.