ACO leakage among gynecologic cancer patients: Incidence, predictors, and impact on annual Medicare expenditure.

OBJECTIVE: To examine patterns of Accountable Care Organizations (ACO) leakage, the receipt of healthcare by ACO-assigned patients from institutions outside assigned ACO network, among patients with gynecologic cancer. ACO leakage was estimated as rates of patients seeking care external to their ACO assignment. Factors associated with ACO leakage were identified and cost differences within the first year of cancer diagnosis described. METHODS: Medicare 5% data (2013-2017) was used to quantify rates of leakage among gynecologic cancer patients with stable ACO assignment. Crude and multivariable adjusted risk ratios of ACO leakage risk factors were estimated using log-binomial regression models. Overall and cancer-specific spending differences by ACO leakage status were compared using Wilcoxon rank-sum test. RESULTS: Overall incidence of ACO leakage was 28.1% with highest leakage for outpatient care and uterine cancer patients. ACO leakage risk was 56% higher among Black relative to White patients, and 77% more for those in higher relative to lowest quintiles of median household income. Leakage decreased by 3% and 8% with each unit increase in ACO size and number of subspecialists, respectively. Healthcare costs were 19.5% higher for leakage patients. CONCLUSIONS: ACO leakage rates among gynecologic cancer patients was overall modest, with some regional and temporal variation, higher leakage for certain subgroups and substantially higher Medicare spending in inpatient and outpatient settings for patients with ACO leakage. These findings identify targets for further investigations and strategies to encourage oncologists to participate in ACOs and prevent increased health care costs associated with use of non-ACO providers.

Dementia and Parkinson's disease diagnoses in electronic health records vs. Medicare claims data: a study of 101,980 linked patients.

BACKGROUND: Medicare claims and electronic health record data are both commonly used for research and clinical practice improvement; however, it is not known how concordant diagnoses of neurodegenerative diseases (NDD, comprising dementia and Parkinson's disease) are in these data types. Therefore, our objective was to determine the sensitivity and specificity of neurodegenerative disease (NDD) diagnoses contained in structured electronic health record (EHR) data compared to Medicare claims data. METHODS: This was a retrospective cohort study of 101,980 unique patients seen at a large North Carolina health system between 2013-2017, which were linked to 100% North and South Carolina Medicare claims data, to evaluate the accuracy of diagnoses of neurodegenerative diseases in EHRs compared to Medicare claims data. Patients age > 50 who were enrolled in fee-for-service Medicare were included in the study. Patients were classified as having or not having NDD based on the presence of validated ICD-CM-9 or ICD-CM-10 codes associated with NDD or claims for prescription drugs used to treat NDD. EHR diagnoses were compared to Medicare claims diagnoses. RESULTS: The specificity of any EHR diagnosis of NDD was 99.0%; sensitivity was 61.3%. Positive predictive value and negative predictive value were 90.8% and 94.1% respectively. Specificity of an EHR diagnosis of dementia was 99.0%, and sensitivity was 56.1%. Specificity of an EHR diagnosis of PD was 99.7%, while sensitivity was 76.1%. CONCLUSIONS: More research is needed to investigate under-documentation of NDD in electronic health records relative to Medicare claims data, which has major implications for clinical practice (particularly patient safety) and research using real-world data.

Racial/ethnic disparities in dementia incidence, outcomes, and health-care utilization.

INTRODUCTION: Racial/ethnic disparities exist in many aspects of health care, but data on racial/ethnic disparities for neurodegenerative diseases (NDDs), such as dementia and Parkinson's disease (PD), are limited. METHODS: We used North and South Carolina Medicare claims from 2013 to 2017 to evaluate disparities in incidence of NDDs and in health-care utilization and outcomes for patients with NDDs. RESULTS: Disparities in incidence of NDD between Black and White beneficiaries narrowed by 0.37 per 100 person-years from 2014 to 2017. After thorough covariate adjustment, Black beneficiaries had a 4% higher risk of all-cause hospitalization, spent 8% more days in skilled nursing facilities and 14% fewer days in hospice facilities, were 38% less likely to receive physical/occupational therapy services, were 8% less likely to receive dementia medications, and were 19% less likely to receive PD medications than White beneficiaries. DISCUSSION: Effective system-level approaches to promote health equity in NDD diagnosis, treatment, and outcomes are clearly needed. HIGHLIGHTS: Racial disparities in neurodegenerative disease incidence narrowed between 2014 and 2017. Black patients were less likely than White patients to receive hospice services. Black patients were less likely than White patients to receive physical therapy. Black patients were less likely than White patients to receive Alzheimer's disease or Parkinson's disease medications. There is a shortage of neurologists in counties with high dementia incidence.

Knowledge, goals, and misperceptions about palliative care in adults with chronic disease or cancer.

OBJECTIVES: Limited evidence investigates how knowledge, misconceptions, and beliefs about palliative care vary across patients with cancerous versus non-cancerous chronic disease. We examined the knowledge of and misconceptions about palliative care among these groups. METHODS: We used weighted data from the National Cancer Institute Health Information National Trends Survey 5 (Cycle 2) for nationally representative estimates and logistic regression to adjust for respondent characteristics. We identified respondents who reported having (1) cancer ([n = 585]; breast, lung, and colorectal), (2) chronic conditions ([n = 543]; heart failure, lung disease, or chronic obstructive pulmonary disorder), or (3) neither cancer nor other chronic conditions (n = 2,376). RESULTS: Compared to cancer respondents, chronic condition respondents were more likely to report being Black or Hispanic, report a disability, and have lower socioeconomic status. In the sample, 65.6% of cancer respondents and 72.8% chronic conditions respondents reported they had never heard of palliative care. Chronic condition respondents were significantly (p < 0.05) less likely to report high palliative care knowledge than cancer respondents (9.1% vs. 16.6%, respectively). In adjusted analyses, cancer respondents had greater odds of high palliative care knowledge (odd ratio [OR] = 1.70; 95% confidence interval [CI] = 1.01, 2.86) compared to respondents with neither cancer nor chronic disease; chronic condition respondents did not have increased odds (OR = 0.96; CI = 0.59, 1.54). SIGNIFICANCE OF RESULTS: Disparities in palliative care knowledge exist among people with non-cancerous chronic disease compared to cancer. Supportive educational efforts to boost knowledge about palliative care remains urgent and is critical for promoting equity, particularly for underserved people with chronic illnesses.

Alternative Payment Models and Associations With Stroke Outcomes, Spending, and Service Utilization: A Systematic Review.

Stroke contributes an estimated $28 billion to US health care costs annually, and alternative payment models aim to improve outcomes and lower spending over fee-for-service by aligning economic incentives with high value care. This systematic review evaluates historical and current evidence regarding the impacts of alternative payment models on stroke outcomes, spending, and utilization. Included studies evaluated alternative payment models in 4 categories: pay-for-performance (n=3), prospective payments (n=14), shared savings (n=5), and capitated payments (n=14). Pay-for-performance models were not consistently associated with improvements in clinical quality indicators of stroke prevention. Studies of prospective payments suggested that poststroke spending was shifted between care settings without consistent reductions in total spending. Shared savings programs, such as US Medicare accountable care organizations and bundled payments, were generally associated with null or decreased spending and service utilization and with no differences in clinical outcomes following stroke hospitalizations. Capitated payment models were associated with inconsistent effects on poststroke spending and utilization and some worsened clinical outcomes. Shared savings models that incentivize coordination of care across care settings show potential for lowering spending with no evidence for worsened clinical outcomes; however, few studies evaluated clinical or patient-reported outcomes, and the evidence, largely US-based, may not generalize to other settings.

Polypharmacy in Palliative Care for Advanced Heart Failure: The PAL-HF Experience.

BACKGROUND: Palliative care (PC) in advanced heart failure (HF) aims to improve symptoms and quality of life (QOL), in part through medication management. The impact of PC on polypharmacy (>5 medications) remains unknown. METHODS AND RESULTS: We explored patterns of polypharmacy in the Palliative Care in HF (PAL-HF) randomized controlled trial of standard care vs interdisciplinary PC in advanced HF (N = 150). We describe differences in medication counts between arms at 2, 6, 12, and 24 weeks for HF (12 classes) and PC (6 classes) medications. General linear mixed models were used to evaluate associations between treatment arm and polypharmacy over time. The median age of the patients was 72 years (interquartile range 62-80 years), 47% were female, and 41% were Black. Overall, 48% had ischemic etiology, and 55% had an ejection fraction of 40% or less. Polypharmacy was present at baseline in 100% of patients. HF and PC medication counts increased in both arms, with no significant differences in counts by drug class at any time point between arms. CONCLUSIONS: In a trial of patients with advanced HF considered eligible for PC, polypharmacy was universal at baseline and increased during follow-up with no effect of the palliative intervention on medication counts relative to standard care.

Cost and Quality of Life Outcomes of the STepped Exercise Program for Patients With Knee OsteoArthritis Trial.

OBJECTIVES: This study aimed to evaluate the cost-effectiveness of the randomized clinical trial STEP-KOA (STepped Exercise Program for patients with Knee OsteoArthritis). METHODS: The trial included 230 intervention and 115 control participants from 2 Veterans Affairs (VA) medical centers. A decision tree simulated outcomes for cohorts of patients receiving arthritis education (control) or STEP-KOA (intervention), which consisted of an internet-based exercise training program (step 1), phone counseling (step 2), and physical therapy (step 3) according to patient's response. Intervention costs were assessed from the VA perspective. Quality of life (QOL) was measured using 5-level EQ-5D US utility weights. Incremental cost-effectiveness ratios (ICERs) were calculated as the difference in costs divided by the difference in quality-adjusted life-years (QALYs) between arms at 9 months. A Monte Carlo probabilistic sensitivity analysis was used to generate a cost-effectiveness acceptability curve. RESULTS: The adjusted model found differential improvement in QOL utility weights of 0.042 (95% confidence interval 0.003-0.080; P=.03) for STEP-KOA versus control at 9 months. In the base case, STEP-KOA resulted in an incremental gain of 0.028 QALYs and an incremental cost of $279 per patient for an ICER of $10 076. One-way sensitivity analyses found the largest sources of variation in the ICER were the impact on QOL and the need for a VA-owned tablet. The probabilistic sensitivity analysis found a 98% probability of cost-effectiveness at $50 000 willingness-to-pay per QALY. CONCLUSIONS: STEP-KOA improves QOL and has a high probability of cost-effectiveness. Resources needed to implement the program will decline as ownership of mobile health devices increases.

Improving Transitions in Care for Patients and Family Caregivers Living in Rural and Underserved Areas: The Caregiver Advise, Record, Enable (CARE) Act.

In this Perspective, we contend bold action is needed to improve transitions from hospitals to home for aging patients and their family caregivers living in rural and underserved areas. The Caregiver Advise, Record, Enable (CARE) Act, passed in over 40 US states, is intended to provide family caregivers of hospitalized patients with the knowledge and skills needed for safe and efficient transitions. It has broken important ground for family caregivers who assist with transitions in patient care. It may fall short, however, in addressing the unique needs of family caregivers living in rural and underserved areas. We contend that to realize the intended safety, cost, and care quality benefits of the CARE Act, especially for those living in rural and underserved areas, states need to expand the Act's scope. We provide three recommendations: 1) modify hospital information systems to support the care provided by family caregivers; 2) require assessments of family caregivers that reflect the challenges of family caregiving in rural and underserved areas; and 3) identify local resources to improve discharge planning. We describe the rationale for each recommendation and the potential ways that an expanded CARE Act could reduce the risks associated with transitions in care for aging patients.

Key Points:1. Recent state laws aim to support family caregivers of hospitalized patients.2. These laws do not account for the unique needs of rural caregivers.3. Expanding laws to address rural caregiver needs may improve patient outcomes.

The Cost-Effectiveness of Palliative Care: Insights from the PAL-HF Trial.

BACKGROUND: In a randomized control trial, Palliative Care in Heart Failure (PAL-HF) improved heart failure-related quality of life, though cost-effectiveness remains unknown. The aim of this study was to evaluate the cost-effectiveness of the PAL-HF trial, which provided outpatient palliative care to patients with advanced heart failure. METHODS AND RESULTS: Outcomes for usual care and PAL-HF strategies were compared using a Markov cohort model over 36 months from a payer perspective. The model parameters were informed by PAL-HF trial data and supplemented with meta-analyses and Medicare administrative data. Outcomes included hospitalization, place of death, Medicare expenditures, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Simulated mortality rates were the same for PAL-HF and usual care cohorts, at 89.7% at 36 months. In the base case analysis, the PAL-HF intervention resulted in an incremental gain of 0.03 QALYs and an incremental cost of $964 per patient for an incremental cost-effectiveness ratio of $29,041 per QALY. In 1-way sensitivity analyses, an intervention cost of up to $140 per month is cost effective at $50,000 per QALY. Of 1000 simulations, the PC intervention had a 66.1% probability of being cost effective at a $50,000 willingness-to-pay threshold assuming no decrease in hospitalization. In a scenario analysis, PAL-HF decreased payer spending through reductions in noncardiovascular hospitalizations. CONCLUSIONS: These results from this single-center trial are encouraging that palliative care for advanced heart failure is an economically attractive intervention. Confirmation of these findings in larger multicenter trials will be an important part of developing the evidence to support more widespread implementation of the PAL-HF palliative care intervention.

State variation in effects of state social distancing policies on COVID-19 cases.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) sickened over 20 million residents in the United States (US) by January 2021. Our objective was to describe state variation in the effect of initial social distancing policies and non-essential business (NEB) closure on infection rates early in 2020. METHODS: We used an interrupted time series study design to estimate the total effect of all state social distancing orders, including NEB closure, shelter-in-place, and stay-at-home orders, on cumulative COVID-19 cases for each state. Data included the daily number of COVID-19 cases and deaths for all 50 states and Washington, DC from the New York Times database (January 21 to May 7, 2020). We predicted cumulative daily cases and deaths using a generalized linear model with a negative binomial distribution and a log link for two models. RESULTS: Social distancing was associated with a 15.4% daily reduction (Relative Risk = 0.846; Confidence Interval [CI] = 0.832, 0.859) in COVID-19 cases. After 3 weeks, social distancing prevented nearly 33 million cases nationwide, with about half (16.5 million) of those prevented cases among residents of the Mid-Atlantic census division (New York, New Jersey, Pennsylvania). Eleven states prevented more than 10,000 cases per 100,000 residents within 3 weeks. CONCLUSIONS: The effect of social distancing on the infection rate of COVID-19 in the US varied substantially across states, and effects were largest in states with highest community spread.

Association of ACO Shared Savings Success and Serious Illness Spending.

EXECUTIVE SUMMARY: Accountable care organizations (ACOs) need confidence in their return on investment to implement changes in care delivery that prioritize seriously ill and high-cost Medicare beneficiaries. The objective of this study was to characterize spending on seriously ill beneficiaries in ACOs with Medicare Shared Savings Program (MSSP) contracts and the association of spending with ACO shared savings. The population included Medicare fee-for-service beneficiaries identified with serious illness (N = 2,109,573) using the Medicare Master Beneficiary Summary File for 100% of ACO-attributed beneficiaries linked to MSSP beneficiary files (2014-2016). Lower spending for seriously ill Medicare beneficiaries and risk-bearing contracts in ACOs were associated with achieving ACO shared savings in the MSSP. For most ACOs, the seriously ill contribute approximately half of the spending and constitute 8%-13% of the attributed population. Patient and geographic (county) factors explained $2,329 of the observed difference in per beneficiary per year spending on seriously ill beneficiaries between high- and low-spending ACOs. The remaining $12,536 may indicate variation as a result of potentially modifiable factors. Consequently, if 10% of attributed beneficiaries were seriously ill, an ACO that moved from the worst to the best quartile of per capita serious illness spending could realize a reduction of $1,200 per beneficiary per year for the ACO population overall. Though the prevalence and case mix of seriously ill populations vary across ACOs, this association suggests that care provided for seriously ill patients is an important consideration for ACOs to achieve MSSP shared savings.

Comparing Associations of State Reopening Strategies with COVID-19 Burden.

BACKGROUND: The novel coronavirus disease 2019 (COVID-19) infected over 5 million United States (US) residents resulting in more than 180,000 deaths by August 2020. To mitigate transmission, most states ordered shelter-in-place orders in March and reopening strategies varied. OBJECTIVE: To estimate excess COVID-19 cases and deaths after reopening compared with trends prior to reopening for two groups of states: (1) states with an evidence-based reopening strategy, defined as reopening indoor dining after implementing a statewide mask mandate, and (2) states reopening indoor dining rooms before implementing a statewide mask mandate. DESIGN: Interrupted time series quasi-experimental study design applied to publicly available secondary data. PARTICIPANTS: Fifty United States and the District of Columbia. INTERVENTIONS: Reopening indoor dining rooms before or after implementing a statewide mask mandate. MAIN MEASURES: Outcomes included daily cumulative COVID-19 cases and deaths for each state. KEY RESULTS: On average, the number of excess cases per 100,000 residents in states reopening without masks is ten times the number in states reopening with masks after 8 weeks (643.1 cases; 95% confidence interval (CI) = 406.9, 879.2 and 62.9 cases; CI = 12.6, 113.1, respectively). Excess cases after 6 weeks could have been reduced by 90% from 576,371 to 63,062 and excess deaths reduced by 80% from 22,851 to 4858 had states implemented mask mandates prior to reopening. Over 50,000 excess deaths were prevented within 6 weeks in 13 states that implemented mask mandates prior to reopening. CONCLUSIONS: Additional mitigation measures such as mask use counteract the potential growth in COVID-19 cases and deaths due to reopening businesses. This study contributes to the growing evidence that mask usage is essential for mitigating community transmission of COVID-19. States should delay further reopening until mask mandates are fully implemented, and enforcement by local businesses will be critical for preventing potential future closures.

Correction to: Comparing Associations of State Reopening Strategies with COVID-19 Burden.

In the original version of this paper, an author was misidentified. The corrected author listing appears here, and has been updated in the online version.

Adaptation and Implementation of a Family Caregiver Skills Training Program: From Single Site RCT to Multisite Pragmatic Intervention.

PURPOSE: We describe an approach to rapidly adapt and implement an education and skills improvement intervention to address the needs of family caregivers of functionally impaired veterans-Helping Invested Families Improve Veterans' Experience Study (HI-FIVES). DESIGN: Prior to implementation in eight sites, a multidisciplinary study team made systematic adaptations to the curriculum content and delivery process using input from the original randomized controlled trial (RCT); a stakeholder advisory board comprised of national experts in caregiver education, nursing, and implementation; and a veteran/caregiver engagement panel. To address site-specific implementation barriers in diverse settings, we applied the Replicating Effective Programs implementation framework. FINDINGS: Adaptations to HI-FIVES content and delivery included identifying core/noncore curriculum components, reducing instruction time, and simplifying caregiver recruitment for clinical settings. To enhance curriculum flexibility and potential uptake, site personnel were able to choose which staff would deliver the intervention and whether to offer class sessions in person or remotely. Curriculum materials were standardized and packaged to reduce the time required for implementation and to promote fidelity to the intervention. CONCLUSIONS: The emphasis on flexible intervention delivery and standardized materials has been identified as strengths of the adaptation process. Two key challenges have been identifying feasible impact measures and reaching eligible caregivers for intervention recruitment. CLINICAL RELEVANCE: This systematic implementation process can be used to rapidly adapt an intervention to diverse clinical sites and contexts. Nursing professionals play a significant role in educating and supporting caregivers and care recipients and can take a leading role to implement interventions that address skills and unmet needs for caregivers.

Disease Burden Following Non-Cardioembolic Minor Ischemic Stroke or High-Risk TIA: A GWTG-Stroke Study.

BACKGROUND: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA. METHODS: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA. RESULTS: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively. CONCLUSIONS: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending.

The Medicare Shared Savings Program and Outcomes for Ischemic Stroke Patients: a Retrospective Cohort Study.

BACKGROUND: Post-stroke care delivery may be affected by provider participation in Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs) through systematic changes to discharge planning, care coordination, and transitional care. OBJECTIVE: To evaluate the association of MSSP with patient outcomes in the year following hospitalization for ischemic stroke. DESIGN: Retrospective cohort SETTING: Get With The Guidelines (GWTG)-Stroke (2010-2014) PARTICIPANTS: Hospitalizations for mild to moderate incident ischemic stroke were linked with Medicare claims for fee-for-service beneficiaries ≥ 65 years (N = 251,605). MAIN MEASURES: Outcomes included discharge to home, 30-day all-cause readmission, length of index hospital stay, days in the community (home-time) at 1 year, and 1-year recurrent stroke and mortality. A difference-in-differences design was used to compare outcomes before and after hospital MSSP implementation for patients (1) discharged from hospitals that chose to participate versus not participate in MSSP or (2) assigned to an MSSP ACO versus not or both. Unique estimates for 2013 and 2014 ACOs were generated. KEY RESULTS: For hospitals joining MSSP in 2013 or 2014, the probability of discharge to home decreased by 2.57 (95% confidence intervals (CI) = - 4.43, - 0.71) percentage points (pp) and 1.84 pp (CI = - 3.31, - 0.37), respectively, among beneficiaries not assigned to an MSSP ACO. Among discharges from hospitals joining MSSP in 2013, beneficiary ACO alignment versus not was associated with increased home discharge, reduced length of stay, and increased home-time. For patients discharged from hospitals joining MSSP in 2014, ACO alignment was not associated with changes in utilization. No association between MSSP and recurrent stroke or mortality was observed. CONCLUSIONS: Among patients with mild to moderate ischemic stroke, meaningful reductions in acute care utilization were observed only for ACO-aligned beneficiaries who were also discharged from a hospital initiating MSSP in 2013. Only 1 year of data was available for the 2014 MSSP cohort, and these early results suggest further study is warranted. REGISTRATION: None.

Evaluation of strategies to support implementation of a hospital walking program: protocol for a type III effectiveness-implementation hybrid trial.

BACKGROUND: STRIDE is a supervised walking program designed to address the negative consequences of immobility during hospitalization for older adults. In an 8-hospital stepped wedge randomized controlled trial, STRIDE was associated with reduced odds of hospital discharge to skilled nursing facility. STRIDE has the potential to become a system-wide approach to address hospital-associated disability in Veteran's Affairs; however, critical questions remain about how best to scale and sustain the program. The overall study goal is to compare the impact of two strategies on STRIDE program penetration (primary), fidelity, and adoption implementation outcomes. METHODS: Replicating Effective Programs will be used as a framework underlying all implementation support activities. In a parallel, cluster randomized trial, we will use stratified blocked randomization to assign hospitals (n = 32) to either foundational support, comprised of standard, low-touch activities, or enhanced support, which includes the addition of tailored, high-touch activities if hospitals do not meet STRIDE program benchmarks at 6 and 8 months following start date. All hospitals begin with foundational support for 6 months until randomization occurs. The primary outcome is implementation penetration defined as the proportion of eligible hospitalizations with ≥ 1 STRIDE walks at 10 months. Secondary outcomes are fidelity and adoption with all implementation outcomes additionally examined at 13 and 16 months. Fidelity will be assessed for STRIDE hospitalizations as the percentage of eligible hospital days with "full dose" of the program, defined as two or more documented walks or one walk for more than 5 min. Program adoption is a binary outcome defined as ≥ 5 patients with a STRIDE walk or not. Analyses will also include patient-level effectiveness outcomes (e.g., discharge to nursing home, length of stay) and staffing and labor costs. We will employ a convergent mixed-methods approach to explore and understand pre-implementation contextual factors related to differences in hospital-level adoption. DISCUSSION: Our study results will dually inform best practices for promoting successful implementation of an evidence-based hospital-based walking program. This information may support other programs by advancing our understanding of how to apply and scale-up national implementation strategies. TRIAL REGISTRATION: This study was registered on June 1, 2021, at ClinicalTrials.gov (identifier NCT04868656 ).

Caregiver recruitment strategies for interventions designed to optimize transitions from hospital to home: lessons from a randomized trial.

Challenges to recruitment of family caregivers exist and are amplified when consent must occur in the context of chaotic healthcare circumstances, such as the transition from hospital to home. The onset of the COVID-19 pandemic during our randomized controlled trial provided an opportunity for a natural experiment exploring and examining different consent processes for caregiver recruitment. The purpose of this publication is to describe different recruitment processes (in-person versus virtual) and compare diversity in recruitment rates in the context of a care recipient's hospitalization. We found rates of family caregiver recruitment for in-person versus virtual were 28% and 23%, respectively (p = 0.01). Differences existed across groups with family caregivers recruited virtually being more likely to be younger, white, have greater than high school education, and not be a spouse or significant other to the care recipient, such as a child. Future work is still needed to identify the modality and timing of family caregiver recruitment to maximize rates and enhance the representativeness of the population for equitable impact.