Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes.

BACKGROUND/AIMS: When the randomized clusters in a cluster randomized trial are selected based on characteristics that influence treatment effectiveness, results from the trial may not be directly applicable to the target population. We used data from two large nursing home-based pragmatic cluster randomized trials to compare nursing home and resident characteristics in randomized facilities to eligible non-randomized and ineligible facilities. METHODS: We linked data from the high-dose influenza vaccine trial and the Music & Memory Pragmatic TRIal for Nursing Home Residents with ALzheimer's Disease (METRICaL) to nursing home assessments and Medicare fee-for-service claims. The target population for the high-dose trial comprised Medicare-certified nursing homes; the target population for the METRICaL trial comprised nursing homes in one of four US-based nursing home chains. We used standardized mean differences to compare facility and individual characteristics across the three groups and logistic regression to model the probability of nursing home trial participation. RESULTS: In the high-dose trial, 4476 (29%) of the 15,502 nursing homes in the target population were eligible for the trial, of which 818 (18%) were randomized. Of the 1,361,122 residents, 91,179 (6.7%) were residents of randomized facilities, 463,703 (34.0%) of eligible non-randomized facilities, and 806,205 (59.3%) of ineligible facilities. In the METRICaL trial, 160 (59%) of the 270 nursing homes in the target population were eligible for the trial, of which 80 (50%) were randomized. Of the 20,262 residents, 973 (34.4%) were residents of randomized facilities, 7431 (36.7%) of eligible non-randomized facilities, and 5858 (28.9%) of ineligible facilities. In the high-dose trial, randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (132.5 vs 145.9 and 91.9, respectively), for-profit status (91.8% vs 66.8% and 68.8%), belonging to a nursing home chain (85.8% vs 49.9% and 54.7%), and presence of a special care unit (19.8% vs 25.9% and 14.4%). In the METRICaL trial randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (103.7 vs 110.5 and 67.0), resource-poor status (4.6% vs 10.0% and 18.8%), and presence of a special care unit (26.3% vs 33.8% and 10.9%). In both trials, the characteristics of residents in randomized facilities were similar across the three groups. CONCLUSION: In both trials, facility-level characteristics of randomized nursing homes differed considerably from those of eligible non-randomized and ineligible facilities, while there was little difference in resident-level characteristics across the three groups. Investigators should assess the characteristics of clusters that participate in cluster randomized trials, not just the individuals within the clusters, when examining the applicability of trial results beyond participating clusters.

Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness.

BACKGROUND: The purpose of the study is to evaluate the effect of an Advance Care Planning (ACP) Video Program on documented Do-Not-Hospitalize (DNH) orders among nursing home (NH) residents with advanced illness. METHODS: Secondary analysis on a subset of NHs enrolled in a cluster-randomized controlled trial (41 NHs in treatment arm implemented the ACP Video Program: 69 NHs in control arm employed usual ACP practices). Participants included long (> 100 days) and short (≤ 100 days) stay residents with advanced illness (advanced dementia or cardiopulmonary disease (chronic obstructive pulmonary disease or congestive heart failure)) in NHs from March 1, 2016 to May 31, 2018 without a documented Do-Not-Hospitalize (DNH) order at baseline. Logistic regression with covariate adjustments was used to estimate the impact of the resident being in a treatment versus control NH on: the proportion of residents with new DNH orders during follow-up; and the proportion of residents with any hospitalization during follow-up. Clustering at the facility-level was addressed using hierarchical models. RESULTS: The cohort included 6,117 residents with advanced illness (mean age (SD) = 82.8 (8.4) years, 65% female). Among long-stay residents (n = 3,902), 9.3% (SE, 2.2; 95% CI 5.0-13.6) and 4.2% (SE, 1.1; 95% CI 2.1-6.3) acquired a new DNH order in the treatment and control arms, respectively (average marginal effect, (AME) 5.0; SE, 2.4; 95% CI, 0.3-9.8). Among short-stay residents with advanced illness (n = 2,215), 8.0% (SE, 1.6; 95% CI 4.6-11.3) and 3.5% (SE 1.0; 95% CI 1.5-5.5) acquired a new DNH order in the treatment and control arms, respectively (AME 4.4; SE, 2.0; 95% CI, 0.5-8.3). Proportion of residents with any hospitalizations did not differ between arms in either cohort. CONCLUSIONS: Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688 .

Functional Status and Survival in Older Nursing Home Residents With Advanced Non-Small-Cell Lung Cancer: A SEER-Medicare Analysis.

PURPOSE: Many older patients with advanced lung cancer have functional limitations and require skilled nursing home care. Function, assessed using activities of daily living (ADL) scores, may help prognostication. We investigated the relationship between ADL impairment and overall survival among older patients with advanced non-small-cell lung cancer (NSCLC) receiving care in nursing homes. METHODS: Using the SEER-Medicare database linked with Minimum Data Set assessments, we identified patients age 65 years and older with NSCLC who received care in nursing homes from 2011 to 2015. We used Cox regression and Kaplan-Meier survival curves to examine the relationship between ADL scores and overall survival among all patients; among patients who received systemic cancer chemotherapy or immunotherapy within 3 months of NSCLC diagnosis; and among patients who did not receive any treatment. RESULTS: We included 3,174 patients (mean [standard deviation] age, 77 [7.4] years [range, 65-102 years]; 1,664 [52.4%] of female sex; 394 [12.4%] of non-Hispanic Black race/ethnicity), 415 (13.1%) of whom received systemic therapy, most commonly with carboplatin-based regimens (n = 357 [86%] patients). The median overall survival was 3.1 months for patients with ADL score < 14, 2.8 months for patients with ADL score between 14 and 17, 2.3 months for patients with ADL score between 18-19, and 1.8 months for patients with ADL score 20+ (log-rank P < .001). The ADL score was associated with increased risk of death (hazard ratio [HR], 1.20; 95% CI, 1.16 to 1.25 per standard deviation). One standard deviation increase in the ADL score was associated with lower overall survival rate among treated (HR, 1.14; 95% CI, 1.02 to 1.27) and untreated (HR, 1.20; 95% CI, 1.15 to 1.26) patients. CONCLUSION: ADL assessment stratified mortality outcomes among older nursing home adults with NSCLC, and may be a useful clinical consideration in this population.

Physical Therapy and Health Care Utilization for Older Adults With Lumbar Spinal Stenosis.

BACKGROUND AND PURPOSE: Lumbar spinal stenosis (LSS) is associated with high health care utilization for older adults. Physical therapy (PT) offers low medical risk and reduced cost burden with functional outcomes that appear to be equivalent to higher risk interventions such as surgery. However, it is unknown whether receipt of PT following incident LSS diagnosis is associated with reduced health care utilization. The objectives of this study were to: (1) compare health characteristics for Medicare beneficiaries who received outpatient PT within 30 days of incident LSS diagnosis to those who did not; (2) compare the 1-year utilization rates for specific health care services for these 2 groups; and (3) quantify the likelihood of progression to specific health services based on the receipt of PT. METHODS: This was a retrospective cohort study using nationally representative claims data for Medicare Part B beneficiaries between 2007 and 2010. Lumbar spinal stenosis was determined using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes. Beneficiaries 65 years and older were classified into 2 groups (PT and no PT) based on receipt of PT within 30 days of initial diagnosis. Baseline characteristics were identified at incident diagnosis. Hazard ratios (HRs) were estimated for the risk of receiving health services outcomes including spinal surgery, spinal injections, chiropractic care, advanced imaging, spinal radiographs, opioid medication, nonopioid analgesics, and hospitalizations beginning on day 31 up to 1 year following incident LSS diagnosis. RESULTS AND DISCUSSION: Among 60 646 Medicare beneficiaries with incident LSS who met the inclusion criteria, 1124 were classified in the PT group and 59 522 in the no PT group. Compared with the PT group, beneficiaries in the no PT group had a greater risk of having hospitalizations (HR = 1.40), opioid medications (HR = 1.29), spinal surgery (HR = 1.29), and spinal radiographs (HR = 1.19) within 1 year. CONCLUSIONS: Fewer than 2% of Medicare beneficiaries received PT within 30 days of initial LSS diagnosis. Receipt of PT was associated with less utilization of higher risk and costly health services for 1 year. These results may inform practitioners when making early decisions about rehabilitative care for older adults with LSS.

Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial.

BACKGROUND: Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. METHODS: We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents' racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. DISCUSSION: This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents' behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2A} TRIAL REGISTRATION: ClinicalTrials.gov NCT03821844 . Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

Trends in antipsychotic prescribing among long-term care residents receiving hospice care.

IMPORTANCE: The Centers for Medicare & Medicaid Services' (CMS) National Partnership to Improve Dementia Care in Nursing Homes ("CMS National Partnership") focuses on reducing antipsychotic prescribing to long-term care residents. Hospice enrollment is not an exclusionary condition for the antipsychotic quality measure reported by CMS. It is unclear how prescribing in hospice may have been impacted by the initiative. OBJECTIVE: Estimate the association of the CMS National Partnership with trends in antipsychotic prescribing among long-term care residents in hospice. DESIGN: Interrupted time-series analysis of a 100% Minimum Data Set sample with linked hospice claims from 2011 to 2017. SETTING: Long-term care nursing facilities. PARTICIPANTS: Older adults ≥65 residing in long-term care (n = 3,741,379) and limited to those enrolled in hospice (n = 821,610). MAIN OUTCOME: Quarterly prevalence of antipsychotic and other psychotropic (antianxiety, hypnotic, antidepressant) use among long-term care residents; overall and among residents with dementia, stratified by hospice enrollment. RESULTS: From 2011 to 2017, parallel declines in antipsychotic prescribing were observed among long-term care residents enrolled and not enrolled in hospice (hospice: decline from 26.8% to 18.7%; non-hospice: decline from 23.0% to 14.4%). Following the 2012 CMS National Partnership, quarterly rates of antipsychotic prescribing declined significantly for both residents enrolled and not enrolled in hospice care. Declines in antipsychotic prescribing were greater for residents with dementia, with similar rates among residents enrolled and not enrolled in hospice. Among residents with dementia enrolled in hospice, use of other psychotropic medication classes including antianxiety, antidepressant, and hypnotic use remained relatively stable over time. CONCLUSIONS AND RELEVANCE: Declines in antipsychotic prescribing during the CMS National Partnership occurred among long-term care residents in hospice, where use may be deemed clinically appropriate. Nursing homes are an important location for the provision of dementia end-of-life care and the drivers of potentially unintended reductions in antipsychotic use merits further investigation.

Prevalence of functional limitations and their associations with systemic cancer therapy among older adults in nursing homes with advanced non-small cell lung cancer.

OBJECTIVES: To determine the relationship of self-care task disabilities with the use of systemic cancer therapies for advanced non-small cell lung cancer (NSCLC) in nursing home patients. MATERIALS AND METHODS: Using the Surveillance, Epidemiology, and End Results-Medicare database linked with Minimum Data Set assessments, we identified nursing home residents with advanced NSCLC from 2011 to 2015. We considered disability in activities of daily living (ADL) including dressing, personal hygiene, toilet use, locomotion on unit, transfer, bed mobility, and eating. We estimated the association between ADL disabilities and receipt of systemic cancer therapies within 3 months of diagnosis. RESULTS: Of the 3174 patients, 2702 (85.2%) experienced disability in one or more ADLs and 64.7% had disability in 5-7 ADLs. A total of 415 (13.1%) patients received systemic therapy. There was a strong association between disability in each ADL and receipt of therapy including dressing (OR, 0.52 [95% CI, 0.42-0.65]), toileting (odds ratio, OR, 0.52 [95% confidence interval, CI, 0.42-0.65]), personal hygiene (OR, 0.48 [95% CI, 0.39-0.59]), transfers (OR, 0.51 [95% CI, 0.41-0.64]), bed mobility (OR, 0.55 [95% CI, 0.44-0.69]), locomotion (OR, 0.57 [95% CI, 0.46-0.71]), or eating (OR, 0.45 [95% CI, 0.31-0.67]). Compared to patients having no ADL disability, patients were less likely to receive chemotherapy if they had disability in 1-2 ADLs (OR, 0.95 [95% CI, 0.66-1.37]), 3-4 ADLs (OR, 0.81 [95% CI, 0.56-1.15]), or 5-7 ADLs (OR, 0.43 [95% CI, 0.33-0.56]). CONCLUSIONS: Systemic cancer therapy is not commonly used in this population and is strongly predicted by disability in self-care tasks.

Persistence of Racial Inequities in Receipt of Influenza Vaccination Among Nursing Home Residents in the United States.

BACKGROUND: We sought to determine if racial differences in influenza vaccination among nursing home (NH) residents during the 2008-2009 influenza season persisted in 2018-2019. METHODS: We conducted a cross-sectional study of NHs certified by the Centers for Medicare & Medicaid Services during the 2018-2019 influenza season in US states with ≥1% Black NH residents and a White-Black gap in influenza vaccination of NH residents (N = 2 233 392) of at least 1 percentage point (N = 40 states). NH residents during 1 October 2018 through 31 March 2019 aged ≥18 years and self-identified as being of Black or White race were included. Residents' influenza vaccination status (vaccinated, refused, and not offered) was assessed. Multilevel modeling was used to estimate facility-level vaccination status and inequities by state. RESULTS: The White-Black gap in influenza vaccination was 9.9 percentage points. In adjusted analyses, racial inequities in vaccination were more prominent at the facility level than at the state level. Black residents disproportionately lived in NHs that had a majority of Blacks residents, which generally had the lowest vaccination. Inequities were most concentrated in the Midwestern region, also the most segregated. Not being offered the vaccine was negligible in absolute percentage points between White residents (2.6%) and Black residents (4.8%), whereas refusals were higher among Black (28.7%) than White residents (21.0%). CONCLUSIONS: The increase in the White-Black vaccination gap among NH residents is occurring at the facility level in more states, especially those with the most segregation.

Impact of an Advance Care Planning Video Intervention on Care of Short-Stay Nursing Home Patients.

BACKGROUND/OBJECTIVES: To assess whether an advance care planning (ACP) video intervention impacts care among short-stay nursing home (NH) patients. DESIGN: PRagmatic trial of Video Education in Nursing Homes (PROVEN) was a pragmatic cluster randomized clinical trial. SETTING: A total of 360 NHs (N = 119 intervention, N = 241 control) owned by two healthcare systems. PARTICIPANTS: A total of 2,538 and 5,290 short-stay patients with advanced dementia or cardiopulmonary disease (advanced illness) in the intervention and control arms, respectively; 23,302 and 50,815 short-stay patients without advanced illness in the intervention and control arms, respectively. INTERVENTION: Five ACP videos were available on tablets or online. Designated champions at each intervention facility were instructed to offer a video to patients (or proxies) on admission. Control facilities used usual ACP practices. MEASUREMENTS: Follow-up time was at most 100 days for each patient. Outcomes included hospital transfers per 1000 person-days alive and the proportion of patients experiencing more than one hospital transfer, more than one burdensome treatment (tube-feeding, parenteral therapy, invasive mechanical intervention, and intensive care unit admission), and hospice enrollment. Champions recorded whether a video was offered in the patients' electronic medical record. RESULTS: There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention versus control groups with advanced illness (rate (95% confidence interval (CI)), 12.3 (11.6-13.1) vs 13.2 (12.5-13.7); rate difference: -0.8; 95% CI = -1.8-0.2)). There was a nonsignificant reduction in hospital transfers per 1000 person-days alive in the intervention versus control among short-stay patients without advanced illness. Secondary outcomes did not differ between groups among patients with and without advanced illness. Based on champion only reports 14.2% and 15.3% of eligible short-stay patients with and without advanced illness were shown videos, respectively. CONCLUSION: An ACP video program did not significantly reduce hospital transfers, burdensome treatment, or hospice enrollment among short-stay NH patients; however, fidelity to the intervention was low.

Association Between Exposure to Hurricane Irma and Mortality and Hospitalization in Florida Nursing Home Residents.

Importance: Nursing home residents are at heightened risk for morbidity and mortality following an exposure to a disaster such as a hurricane or the COVID19 pandemic. Previous research has shown that nursing home resident mortality related to disasters is frequently underreported. There is a need to better understand the consequences of disasters on nursing home residents and to differentiate vulnerability based on patient characteristics. Objective: To evaluate mortality and morbidity associated with exposure to Hurricane Irma, a Category 4 storm that made landfall on September 10, 2017, in Cudjoe Key, Florida, among short-stay (<90-day residence) and long-stay (≥90-day residence) residents of nursing homes. Design, Setting, and Participants: Cohort study of Florida nursing home residents comparing residents exposed to Hurricane Irma in September 2017 to a control group of residents residing at the same nursing homes over the same time period in calendar year 2015. Data were analyzed from August 28, 2019, to July 22, 2020. Exposure: Residents who experienced Hurricane Irma were considered exposed; those who did not were considered unexposed. Main Outcome and Measures: Outcome variables included 30-day and 90-day mortality and first hospitalizations after the storm in both the short term and the long term. Results: A total of 61 564 residents who were present in 640 Florida nursing home facilities on September 7, 2017, were identified. A comparison cohort of 61 813 residents was evaluated in 2015. Both cohorts were mostly female (2015, 68%; 2017, 67%), mostly White (2015, 79%; 2017, 78%), and approximately 40% of the residents in each group were over the age of 85 years. Compared with the control group in 2015, an additional 262 more nursing home deaths were identified at 30 days and 433 more deaths at 90 days. The odds of a first hospitalization for those exposed (vs nonexposed) were 1.09 (95% CI, 1.05-1.13) within the first 30 days after the storm and 1.05 (95% CI, 1.02-1.08) at 90 days; the odds of mortality were 1.12 (95% CI, 1.05-1.18) at 30 days and 1.07 (95% CI, 1.03-1.11) at 90 days. Among long-stay residents, the odds of mortality for those exposed to Hurricane Irma were 1.18 (95% CI, 1.08-1.29) times those unexposed and the odds of hospitalization were 1.11 (95% CI, 1.04-1.18) times those unexposed in the post 30-day period. Conclusions and Relevance: The findings of this study suggest that nursing home residents are at considerable risk to the consequences of disasters. These risks may be underreported by state and federal agencies. Long-stay residents, those who have resided in a nursing home for 90 days or more, may be most vulnerable to the consequences of hurricane disasters.

Electronic Health Record Portal Messages and Interactive Voice Response Calls to Improve Rates of Early Season Influenza Vaccination: Randomized Controlled Trial.

BACKGROUND: Patient reminders for influenza vaccination, delivered via an electronic health record patient portal and interactive voice response calls, offer an innovative approach to engaging patients and improving patient care. OBJECTIVE: The goal of this study was to test the effectiveness of portal and interactive voice response outreach in improving rates of influenza vaccination by targeting patients in early September, shortly after vaccinations became available. METHODS: Using electronic health record portal messages and interactive voice response calls promoting influenza vaccination, outreach was conducted in September 2015. Participants included adult patients within a large multispecialty group practice in central Massachusetts. Our main outcome was electronic health record-documented early influenza vaccination during the 2015-2016 influenza season, measured in November 2015. We randomly assigned all active portal users to 1 of 2 groups: (1) receiving a portal message promoting influenza vaccinations, listing upcoming clinics, and offering online scheduling of vaccination appointments (n=19,506) or (2) receiving usual care (n=19,505). We randomly assigned all portal nonusers to 1 of 2 groups: (1) receiving interactive voice response call (n=15,000) or (2) receiving usual care (n=43,596). The intervention also solicited patient self-reports on influenza vaccinations completed outside the clinic. Self-reported influenza vaccination data were uploaded into the electronic health records to increase the accuracy of existing provider-directed electronic health record clinical decision support (vaccination alerts) but were excluded from main analyses. RESULTS: Among portal users, 28.4% (5549/19,506) of those randomized to receive messages and 27.1% (5294/19,505) of the usual care group had influenza vaccinations documented by November 2015 (P=.004). In multivariate analysis of portal users, message recipients were slightly more likely to have documented vaccinations when compared to the usual care group (OR 1.07, 95% CI 1.02-1.12). Among portal nonusers, 8.4% (1262/15,000) of those randomized to receive calls and 8.2% (3586/43,596) of usual care had documented vaccinations (P=.47), and multivariate analysis showed nonsignificant differences. Over half of portal messages sent were opened (10,112/19,479; 51.9%), and over half of interactive voice response calls placed (7599/14,984; 50.7%) reached their intended target, thus we attained similar levels of exposure to the messaging for both interventions. Among portal message recipients, 25.4% of message openers (2570/10,112) responded to a subsequent question on receipt of influenza vaccination; among interactive voice response recipients, 72.5% of those reached (5513/7599) responded to a similar question. CONCLUSIONS: Portal message outreach to a general primary care population achieved a small but statistically significant improvement in rates of influenza vaccination (OR 1.07, 95% CI 1.02-1.12). Interactive voice response calls did not significantly improve vaccination rates among portal nonusers (OR 1.03, 95% CI 0.96-1.10). Rates of patient engagement with both modalities were favorable. TRIAL REGISTRATION: ClinicalTrials.gov NCT02266277; https://clinicaltrials.gov/ct2/show/NCT02266277.

Advance Care Planning Video Intervention Among Long-Stay Nursing Home Residents: A Pragmatic Cluster Randomized Clinical Trial.

Importance: Standardized, evidenced-based approaches to conducting advance care planning (ACP) in nursing homes are lacking. Objective: To test the effect of an ACP video program on hospital transfers, burdensome treatments, and hospice enrollment among long-stay nursing home residents with and without advanced illness. Design, Setting, and Participants: The Pragmatic Trial of Video Education in Nursing Homes was a pragmatic cluster randomized clinical trial conducted between February 1, 2016, and May 31, 2019, at 360 nursing homes (119 intervention and 241 control) in 32 states owned by 2 for-profit corporations. Participants included 4171 long-stay residents with advanced dementia or cardiopulmonary disease (hereafter referred to as advanced illness) in the intervention group and 8308 long-stay residents with advanced illness in the control group, 5764 long-stay residents without advanced illness in the intervention group, and 11 773 long-stay residents without advanced illness in the control group. Analyses followed the intention-to-treat principle. Interventions: Five 6- to 10-minute ACP videos were made available on tablet computers or online. Designated champions (mostly social workers) in intervention facilities were instructed to offer residents (or their proxies) the opportunity to view a video(s) on admission and every 6 months. Control facilities used usual ACP practices. Main Outcomes and Measures: Twelve-month outcomes were measured for each resident. The primary outcome was hospital transfers per 1000 person-days alive in the advanced illness cohort. Secondary outcomes included the proportion of residents with or without advanced illness experiencing 1 or more hospital transfer, 1 or more burdensome treatment, and hospice enrollment. To monitor fidelity, champions completed reports in the electronic record whenever they offered to show residents a video. Results: The study included 4171 long-stay residents with advanced illness in the intervention group (2970 women [71.2%]; mean [SD] age, 83.6 [9.1] years), and 8308 long-stay residents with advanced illness in the control group (5857 women [70.5%]; mean [SD] age, 83.6 [8.9] years), 5764 long-stay residents without advanced illness in the intervention group (3692 women [64.1%]; mean [SD] age, 81.5 [9.2] years), and 11 773 long-stay residents without advanced illness in the control group (7467 women [63.4%]; mean [SD] age, 81.3 [9.2] years). There was no significant reduction in hospital transfers per 1000 person-days alive in the intervention vs control groups (rate [SE], 3.7 [0.2]; 95% CI, 3.4-4.0 vs 3.9 [0.3]; 95% CI, 3.6-4.1; rate difference [SE], -0.2 [0.3]; 95% CI, -0.5 to 0.2). Secondary outcomes did not significantly differ between trial groups among residents with and without advanced illness. Based on champions' reports, 912 of 4171 residents with advanced illness (21.9%) viewed ACP videos. Facility-level rates of showing ACP videos ranged from 0% (14 of 119 facilities [11.8%]) to more than 40% (22 facilities [18.5%]). Conclusions and Relevance: This study found that an ACP video program was not effective in reducing hospital transfers, decreasing burdensome treatment use, or increasing hospice enrollment among long-stay residents with or without advanced illness. Intervention fidelity was low, highlighting the challenges of implementing new programs in nursing homes. Trial Registration: ClinicalTrials.gov Identifier: NCT02612688.

Hospital Transfer Rates Among US Nursing Home Residents With Advanced Illness Before and After Initiatives to Reduce Hospitalizations.

Importance: Hospital transfers among nursing home residents in the United States who have been diagnosed with advanced illnesses and have limited life expectancy are often burdensome, costly, and of little clinical benefit. National initiatives, introduced since 2012, have focused on reducing such hospitalizations, but little is known about the consequences of these initiatives in this population. Objective: To investigate the change in hospital transfer rates among nursing home residents with advanced illnesses, such as dementia, congestive heart failure (CHF), and chronic obstructive pulmonary disease (COPD), from 2011 to 2017-before and after the introduction of national initiatives to reduce hospitalizations. Design, Setting, and Participants: In this cross-sectional study, nationwide Minimum Data Set (MDS) assessments from January 1, 2011, to December 31, 2016 (with the follow-up for transfer rates until December 31, 2017), were used to identify annual inception cohorts of long-stay (>100 days) nursing home residents who had recently progressed to the advanced stages of dementia, CHF, or COPD. The data were analyzed from October 24, 2018, to October 3, 2019. Main Outcomes and Measures: The number of hospital transfers (hospitalizations, observation stays, and emergency department visits) per person-year alive was calculated from the MDS assessment from the date when residents first met the criteria for advanced illness up to 12 months afterward using Medicare claims from 2011 to 2017. Transfer rates for all causes, potentially avoidable conditions (sepsis, pneumonia, dehydration, urinary tract infections, CHF, and COPD), and serious bone fractures (pelvis, hip, wrist, ankle, and long bones of arms or legs) were investigated. Hospice enrollment and mortality were also ascertained. Results: The proportions of residents in the 2011 and 2016 cohorts who underwent any hospital transfer were 56.1% and 45.4% of those with advanced dementia, 77.6% and 69.5% of those with CHF, and 76.2% and 67.2% of those with COPD. The mean (SD) number of transfers per person-year alive for potentially avoidable conditions was higher in the 2011 cohort vs 2016 cohort: advanced dementia, 2.4 (14.0) vs 1.6 (11.2) (adjusted risk ratio [aRR], 0.73; 95% CI, 0.65-0.81); CHF, 8.5 (32.0) vs 6.7 (26.8) (aRR, 0.72; 95% CI, 0.65-0.81); and COPD, 7.8 (30.9) vs 5.5 (24.8) (aRR, 0.64; 95% CI, 0.57-0.72). Transfers for bone fractures remained unchanged, and mortality did not increase. Hospice enrollment was low across all illness groups and years (range, 23%-30%). Conclusions and Relevance: The findings of this study suggest that concurrent with new initiatives aimed at reducing hospitalizations, hospital transfers declined between 2011 and 2017 among nursing home residents with advanced illnesses without increased mortality rates. Opportunities remain to further reduce unnecessary hospital transfers in this population and improve goal-directed care for those residents who opt to forgo hospitalization.

The Minimum Data Set Agitated and Reactive Behavior Scale: Measuring Behaviors in Nursing Home Residents With Dementia.

OBJECTIVES: Interventions aimed at managing agitated and aggressive behaviors in dementia without the use of antipsychotics are currently being tested in nursing homes (NHs). Researchers and clinicians require a measure that can capture the severity of residents' behaviors. We test the internal consistency and construct validity of the Agitated and Reactive Behavior Scale (ARBS), a measure created using data from mandatory NH assessments. DESIGN: Cross-sectional. SETTING AND PARTICIPANTS: The 2016 national sample of 15,326 Centers for Medicare and Medicaid Services-certified NHs. The analytic sample included 489,854 new admissions and 765,367 long-stay residents (at least 90 days in NH). All participants have a dementia diagnosis. METHODS: Minimum Data Set (MDS), version 3.0. The ARBS is a composite measure of (1) physical behavioral symptoms directed at other people; (2) verbal behavioral symptoms directed at other people; (3) other behavioral symptoms not directed at other people; and (4) rejection of care. Variables used to establish construct validity included degree of cognitive impairment, use of medications for managing agitation and aggression, and co-occurring conditions associated with agitated and aggressive behaviors (eg, schizophrenia, depression, or delirium). RESULTS: This report has 3 important findings: (1) the ARBS score has borderline-adequate internal consistency (α = .64-.71) in the national population NH residents with dementia; (2) only 18% of new admissions and 21% of long-stay residents with dementia evidence any agitated or aggressive behaviors in the last week, as rated in the MDS assessment; and (3) the ARBS demonstrates good construct validity; it increases with cognitive impairment, treatment with relevant medications, and co-occurring psychiatric conditions and symptoms. DISCUSSION: Nationally available MDS data may significantly underestimate the prevalence of agitated and aggressive behaviors among NH residents with dementia. CONCLUSIONS AND IMPLICATIONS: Researchers conducting pragmatic trials of non-pharmaceutical interventions to manage behaviors in NH residents with dementia should consider the likely underdetection of these behaviors in the available MDS data.

Racial Disparities in Medicaid Home and Community-Based Service Utilization among White, Black, and Hispanic Adults with Multiple Sclerosis: Implications of State Policy.

Home- and community-based services (HCBS) provide support to individuals needing assistance with daily activities, like people with multiple sclerosis (MS) who often experience functional impairment. Research notes racial differences in HCBS utilization among people with MS, which may be attributed to state's relative amount of long-term service and support (LTSS) expenditures dedicated to HCBS (HCBS priority). As a first step in untangling this mechanism, we explored how HCBS priority may contribute to racial differences in service utilization. Using Medicaid claims data for a national cohort of dual eligibles with MS, we find state HCBS priority is associated with disparities in utilization-blacks and Hispanics receiving HCBS more often do so in low-priority states compared with whites. Findings indicate a need for additional research focusing on health equity to further examine effects on quality of life and health outcomes of individuals who would benefit from more generous HCBS policies, specifically determining whether minorities in low-HCBS states fare worse than those in high-priority states. Findings from the present study can help policymakers more effectively design HCBS programs for diverse individuals.

Cost Benefit of High-Dose vs Standard-Dose Influenza Vaccine in a Long-Term Care Population During an A/H1N1-Predominant Influenza Season.

OBJECTIVES: Influenza is a leading cause of avoidable admissions for nursing home (NH) residents. We previously evaluated the effectiveness of a high-dose trivalent influenza vaccine (HD) compared to a standard-dose influenza vaccine (SD) through a cluster-randomized trial of NH residents. Fewer residents from facilities randomized to HD were hospitalized. In this article, we extend our analyses to consider direct medical care costs relative to vaccine costs for HD ($31.82/dose) as compared to SD ($12.04/dose). DESIGN: Post hoc, cost-benefit analysis. SETTING AND PARTICIPANTS: From the participating NH facilities (n = 817), we identified Medicare fee-for-service enrollees who were long-stay residents (>100 days) at the start of the 2013-2014 influenza season (November 1-May 31). The intervention was residence in a facility randomized to HD or SD influenza vaccine. METHODS: We summed expenditures from long-stay NH residents' Medicare Part A, B, and D fee-for-service claims and compared person-level expenditures between residents of facilities offering HD vs SD. Expenditures were adjusted for clustering of residents within NHs, person-time, and prespecified covariates using 2-part, generalized linear models with bootstrapped standard errors. We examined the incremental cost-benefit of HD vs SD vaccines from a payer perspective. RESULTS: There were 18,605 and 18,658 Medicare fee-for-service long-stay residents in facilities offering HD and SD, respectively. Person- and facility-adjusted total expenditures differed by $546 (P = .006). The $20 incremental cost of HD to SD offset adjusted expenditures for a net benefit of $526 per NH resident and a financial return on investment of 546/20 = 27:1. CONCLUSIONS/IMPLICATIONS: The use of HD influenza vaccine in long-stay NH residents reduced total health care expenditures for a net benefit despite HD being more expensive per dose. These cost offsets applied to Medicare beneficiaries residing in NHs could result in important savings to the Medicare program.

Development and Validation of the Nursing Home Minimum Data Set 3.0 Mortality Risk Score (MRS3).

Background: To develop a score to predict mortality using the Minimum Data Set 3.0 (MDS 3.0) that can be readily calculated from items collected during nursing home (NH) residents' admission assessments. Participants: We developed a training cohort of Medicare beneficiaries newly admitted to United States NHs during 2012 (N = 1,426,815) and a testing cohort from 2013 (N = 1,160,964). Methods: Data came from the MDS 3.0 assessments linked to the Medicare Beneficiary Summary File. Using the training dataset, we developed a composite MDS 3.0 Mortality Risk Score (MRS3) consisting of 17 clinical items and patients' age groups based on their relation to 30-day mortality. We assessed the calibration and discrimination of the MRS3 in predicting 30- and 60-day mortality and compared its performance to the Charlson Comorbidity Index and the clinician's assessment of 6-month prognosis measured at admission. Results: The 30- and 60-day mortality rates for the testing population were 2.8% and 5.6%, respectively. Results from logistic regression models suggest that the MRS3 performed well in predicting death within 30 and 60 days (C-Statistics of 0.744 [95% confidence limit (CL) = 0.741, 0.747] and 0.709 [95% CL = 0.706, 0.711], respectively). The MRS3 was a superior predictor of mortality compared to the Charlson Comorbidity Index (C-statistics of 0.611 [95% CL = 0.607, 0.615] and 0.608 [95% CL = 0.605, 0.610]) and the clinicians' assessments of patients' 6-month prognoses (C-statistics of 0.543 [95% CL = 0.542, 0.545] and 0.528 [95% CL = 0.527, 0.529]). Conclusions: The MRS3 is a good predictor of mortality and can be useful in guiding decision-making, informing plans of care, and adjusting for patients' risk of mortality.

A New Data Resource to Examine Meals on Wheels Clients' Health Care Utilization and Costs.

BACKGROUND: Access to social services (eg, nutrition) can impact older adults' health care utilization and health outcomes. However, data documenting the relationship between receiving services and objective measures of health care utilization remain limited. OBJECTIVES: To link Meals on Wheels (MOW) program data to Medicare claims to enable examination of clients' health and health care utilization and to highlight the utility of this linked dataset. RESEARCH DESIGN: Using probabilistic linking techniques, we matched MOW client data to Medicare enrollment and claims data. Descriptive information is presented on clients' health and health care utilization before and after receiving services from MOW. SUBJECTS: In total, 29,501 clients were from 13 MOW programs. MEASURES: Clients' demographics, chronic conditions, and hospitalization, emergency department (ED), and nursing home (NH) utilization rates. RESULTS: We obtained a one-to-one link for 25,279 clients. Among these, 14,019 were Medicare fee-for-service (FFS) beneficiaries and met inclusion criteria for additional analyses. MOW clients had high rates of chronic conditions (eg, almost 90% of FFS clients were diagnosed with hypertension, compared with 63% of FFS beneficiaries in their communities). In the 6 months before receiving MOW services, 31.6% of clients were hospitalized, 24.9% were admitted to the ED and 13% received care in a NH. In the 6 months after receiving meals, 24.2% were hospitalized, 19.3% were admitted to the ED, and 9.5% received care in a NH. CONCLUSIONS: Linking MOW data to Medicare claims has the potential to shed additional light on the relationships among social services, health status, health care use, and benefits to clients' well-being.

Racial disparities in Medicaid home and community-based service utilization and expenditures among persons with multiple sclerosis.

BACKGROUND: Medicaid home and community-based services (HCBS) provide services such as personal care, nursing, and home-delivered meals to aging adults and individuals with disabilities. HCBS are available to people across racial and ethnic groups, yet racial disparities in Medicaid HCBS utilization and expenditures have been understudied. Individuals with multiple sclerosis (MS) may be particularly impacted by HCBS, as nearly one-third requires assistance at home. The present study examined whether disparities exist in Medicaid HCBS utilization and expenditures among HCBS users with MS. METHODS: We used secondary data to conduct a retrospective cohort analyses including 7550 HCBS recipients with MS. Demographic data was obtained from the Medicaid Analytic eXtract Personal Summary file, Medicaid HCBS service utilization and expenditures were obtained from the Other Therapy file, and comorbidities from the Medicare Chronic Condition Warehouse. Univariate and bivariate statistics were used to describe the sample and provide comparisons of characteristic by race. Logistic regression predicted the likelihood of using HCBS type and gamma regression was used to predict Medicaid HCBS expenditures. RESULTS: Black HCBS users were younger, more likely to be female, and were more impaired than Whites. Multivariate analyses showed that Blacks were less likely to receive case management, equipment, technology and modification services, and nursing services compared to Whites. Additionally, Black men had the lowest Medicaid HCBS expenditures, while White men had the highest. CONCLUSIONS: Findings shed light on disparities among HCBS users with MS. As Blacks are already disproportionately affected by MS, these results reveal target areas for future research. Future work should examine the factors that contribute to these disparities, as well as determine the extent to which these inequities impact outcomes such as hospitalizations and nursing home admissions.

Site of Death, Place of Care, and Health Care Transitions Among US Medicare Beneficiaries, 2000-2015.

Importance: End-of-life care costs are high and decedents often experience poor quality of care. Numerous factors influence changes in site of death, health care transitions, and burdensome patterns of care. Objective: To describe changes in site of death and patterns of care among Medicare decedents. Design, Setting, and Participants: Retrospective cohort study among a 20% random sample of 1 361 870 decedents who had Medicare fee-for-service (2000, 2005, 2009, 2011, and 2015) and a 100% sample of 871 845 decedents who had Medicare Advantage (2011 and 2015) and received care at an acute care hospital, at home or in the community, at a hospice inpatient care unit, or at a nursing home. Exposures: Secular changes between 2000 and 2015. Main Outcomes and Measures: Medicare administrative data were used to determine site of death, place of care, health care transitions, which are changes in location of care, and burdensome patterns of care. Burdensome patterns of care were based on health care transitions during the last 3 days of life and multiple hospitalizations for infections or dehydration during the last 120 days of life. Results: The site of death and patterns of care were studied among 1 361 870 decedents who had Medicare fee-for-service (mean [SD] age, 82.8 [8.4] years; 58.7% female) and 871 845 decedents who had Medicare Advantage (mean [SD] age, 82.1 [8.5] years; 54.0% female). Among Medicare fee-for-service decedents, the proportion of deaths that occurred in an acute care hospital decreased from 32.6% (95% CI, 32.4%-32.8%) in 2000 to 19.8% (95% CI, 19.6%-20.0%) in 2015, and deaths in a home or community setting that included assisted living facilities increased from 30.7% (95% CI, 30.6%-30.9%) in 2000 to 40.1% (95% CI, 39.9%-30.3% ) in 2015. Use of the intensive care unit during the last 30 days of life among Medicare fee-for-service decedents increased from 24.3% (95% CI, 24.1%-24.4%) in 2000 and then stabilized between 2009 and 2015 at 29.0% (95% CI, 28.8%-29.2%). Among Medicare fee-for-service decedents, health care transitions during the last 3 days of life increased from 10.3% (95% CI, 10.1%-10.4%) in 2000 to a high of 14.2% (95% CI, 14.0%-14.3%) in 2009 and then decreased to 10.8% (95% CI, 10.6%-10.9%) in 2015. The number of decedents enrolled in Medicare Advantage during the last 90 days of life increased from 358 600 in 2011 to 513 245 in 2015. Among decedents with Medicare Advantage, similar patterns in the rates for site of death, place of care, and health care transitions were observed. Conclusions and Relevance: Among Medicare fee-for-service beneficiaries who died in 2015 compared with 2000, there was a lower likelihood of dying in an acute care hospital, an increase and then stabilization of intensive care unit use during the last month of life, and an increase and then decline in health care transitions during the last 3 days of life.