Comparative safety of tramadol and other opioids following total hip and knee arthroplasty.

BACKGROUND: Tramadol is increasingly used to treat acute postoperative pain among older adults following total hip and knee arthroplasty (THA/TKA). However, tramadol has a complex pharmacology and may be no safer than full opioid agonists. We compared the safety of tramadol, oxycodone, and hydrocodone among opioid-naïve older adults following elective THA/TKA. METHODS: This retrospective cohort included Medicare Fee-for-Service beneficiaries ≥ 65 years with elective THA/TKA between January 1, 2010 and September 30, 2015, 12 months of continuous Parts A and B enrollment, 6 months of continuous Part D enrollment, and no opioid use in the 6 months prior to THA/TKA. Participants initiated single-opioid therapy with tramadol, oxycodone, or hydrocodone within 7 days of discharge from THA/TKA hospitalization, regardless of concurrently administered nonopioid analgesics. Outcomes of interest included all-cause hospitalizations or emergency department visits (serious adverse events (SAEs)) and a composite of 10 surgical- and opioid-related SAEs within 90-days of THA/TKA. The intention-to-treat (ITT) and per-protocol (PP) hazard ratios (HRs) for tramadol versus other opioids were estimated using inverse-probability-of-treatment-weighted pooled logistic regression models. RESULTS: The study population included 2,697 tramadol, 11,407 oxycodone, and 14,665 hydrocodone initiators. Compared to oxycodone, tramadol increased the rate of all-cause SAEs in ITT analyses only (ITT HR 1.19, 95%CLs, 1.02, 1.41; PP HR 1.05, 95%CLs, 0.86, 1.29). Rates of composite SAEs were not significant across comparisons. Compared to hydrocodone, tramadol increased the rate of all-cause SAEs in the ITT and PP analyses (ITT HR 1.40, 95%CLs, 1.10, 1.76; PP HR 1.34, 95%CLs, 1.03, 1.75), but rates of composite SAEs were not significant across comparisons. CONCLUSIONS: Postoperative tramadol was associated with increased rates of all-cause SAEs, but not composite SAEs, compared to oxycodone and hydrocodone. Tramadol does not appear to have a superior safety profile and should not be preferentially prescribed to opioid-naïve older adults following THA/TKA.

Sliding Scale Insulin Use in Nursing Homes Before and After Onset of the COVID-19 Pandemic.

OBJECTIVE: To characterize sliding-scale insulin (SSI) use in US nursing homes (NHs) before and after the COVID-19 pandemic. DESIGN: Cross-sectional study. SETTING AND PARTICIPANTS: A total of 129,829 US NH residents on SSI (01/2018-06/2022) across 12 NH chains with a common electronic health record system. METHODS: Among all residents with at least 1 administration of SSI documented in the electronic medication administration record, we described resident demographics, frequency of SSI monotherapy vs combination therapy with another diabetes medication, number of daily capillary blood glucose readings ("fingersticks"), and hypoglycemia (capillary blood glucose <70 mg/dL) and hyperglycemia after first SSI use. We used interrupted time series analysis (ITS) with segmented linear regression models to examine whether the monthly prevalence of SSI use changed at and after the onset of the COVID-19 pandemic (March 2020). RESULTS: There were 129,829 unique NH residents with SSI use [51% women, average age 71.3 (SD 11.7) years]. Of these, 36% of residents received SSI monotherapy and 64% received SSI combination therapy. Residents on SSI received an average of 3.96 (SD 1.41) fingersticks per day. Overall, 26% of SSI users experienced a hypoglycemic event within 30 days of the first SSI dose. The ITS analysis identified a step decrease in the rate of SSI use following the onset of the COVID-19 pandemic (43 fewer SSI users per 1000 insulin users) but no change in overall trend over time from before the onset of the pandemic. CONCLUSIONS AND IMPLICATIONS: SSI use and fingerstick burden are high in NH residents. Hypoglycemia occurred commonly among residents on SSI. Future research should compare the safety and effectiveness of SSI monotherapy vs other diabetes medication regimens to guide person-centered prescribing decisions in NHs.

COVID-19 and Influenza Vaccine Coadministration Among Older U.S. Adults.

INTRODUCTION: Coadministering COVID-19 and influenza vaccines is recommended by public health authorities and intended to improve uptake and convenience; however, the extent of vaccine coadministration is largely unknown. Investigations into COVID-19 and influenza vaccine coadministration are needed to describe compliance with newer recommendations and to identify potential gaps in the implementation of coadministration. METHODS: A descriptive, repeated cross-sectional study between September 1, 2021 to November 30, 2021 (Period 1) and September 1, 2022 to November 30, 2022 (Period 2) was conducted. This study included community-dwelling Medicare beneficiaries ≥ 66 years who received an mRNA COVID-19 booster vaccine in Periods 1 and 2. The outcome was an influenza vaccine administered on the same day as the COVID-19 vaccine. Adjusted ORs and 99% CIs were estimated using logistic regression to describe the association between beneficiaries' characteristics and vaccine coadministration. Statistical analysis was performed in 2023. RESULTS: Among beneficiaries who received a COVID-19 vaccine, 78.8% in Period 1 (N=6,292,777) and 89.1% in Period 2 (N=4,757,501), received an influenza vaccine at some point during the study period (i.e., before, after, or on the same day as their COVID-19 vaccine), though rates were lower in non-White and rural individuals. Vaccine coadministration increased from 11.1% to 36.5% between periods. Beneficiaries with dementia (aORPeriod 2=1.31; 99%CI=1.29-1.32) and in rural counties (aORPeriod 2=1.19; 99%CI=1.17-1.20) were more likely to receive coadministered vaccines, while those with cancer (aORPeriod 2=0.90; 99%CI=0.89-0.91) were less likely. CONCLUSIONS: Among Medicare beneficiaries vaccinated against COVID-19, influenza vaccination was high, but coadministration of the 2 vaccines was low. Future work should explore which factors explain variation in the decision to receive coadministered vaccines.

Factors Affecting Post-trial Sustainment or De-implementation of Study Interventions: A Narrative Review.

In contrast to traditional randomized controlled trials, embedded pragmatic clinical trials (ePCTs) are conducted within healthcare settings with real-world patient populations. ePCTs are intentionally designed to align with health system priorities leveraging existing healthcare system infrastructure and resources to ease intervention implementation and increase the likelihood that effective interventions translate into routine practice following the trial. The NIH Pragmatic Trials Collaboratory, funded by the National Institutes of Health (NIH), supports the conduct of large-scale ePCT Demonstration Projects that address major public health issues within healthcare systems. The Collaboratory has a unique opportunity to draw on the Demonstration Project experiences to generate lessons learned related to ePCTs and the dissemination and implementation of interventions tested in ePCTs. In this article, we use case studies from six completed Demonstration Projects to summarize the Collaboratory's experience with post-trial interpretation of results, and implications for sustainment (or de-implementation) of tested interventions. We highlight three key lessons learned. First, ineffective interventions (i.e., ePCT is null for the primary outcome) may be sustained if they have other measured benefits (e.g., secondary outcome or subgroup) or even perceived benefits (e.g., staff like the intervention). Second, effective interventions-even those solicited by the health system and/or designed with significant health system partner buy-in-may not be sustained if they require significant resources. Third, alignment with policy incentives is essential for achieving sustainment and scale-up of effective interventions. Our experiences point to several recommendations to aid in considering post-trial sustainment or de-implementation of interventions tested in ePCTs: (1) include secondary outcome measures that are salient to health system partners; (2) collect all appropriate data to allow for post hoc analysis of subgroups; (3) collect experience data from clinicians and staff; (4) engage policy-makers before starting the trial.

Using Structured Observations to Evaluate the Effects of a Personalized Music Intervention on Agitated Behaviors and Mood in Nursing Home Residents With Dementia: Results From an Embedded, Pragmatic Randomized Controlled Trial.

OBJECTIVE: The objective of this research was to determine if a personalized music intervention reduced the frequency of agitated behaviors as measured by structured observations of nursing home (NH) residents with dementia. DESIGN: The design was a parallel, cluster-randomized, controlled trial. SETTING: The setting was 54 NH (27 intervention, 27 control) from four geographically-diverse, multifacility NH corporations. PARTICIPANTS: The participants were 976 NH residents (483 intervention, 493 control) with Alzheimer's disease or related dementias (66% with moderate to severe symptoms); average age 80.3 years (SD: 12.3) and 25.1% were Black. INTERVENTION: The intervention was individuals' preferred music delivered via a personalized music device. MEASUREMENT: The measurement tool was the Agitated Behavior Mapping Instrument, which captures the frequency of 13 agitated behaviors and five mood states during 3-minute observations. RESULTS: The results show that no verbally agitated behaviors were reported in a higher proportion of observations among residents in NHs randomized to receive the intervention compared to similar residents in NHs randomized to usual care (marginal interaction effect (MIE): 0.061, 95% CI: 0.028-0.061). Residents in NHs randomized to receive the intervention were also more likely to be observed experiencing pleasure compared to residents in usual care NHs (MIE: 0.038; 95% CI: 0.008-0.073)). There was no significant effect of the intervention on physically agitated behaviors, anger, fear, alertness, or sadness. CONCLUSIONS: The conclusions are that personalized music may be effective at reducing verbally-agitated behaviors. Using structured observations to measure behaviors may avoid biases of staff-reported measures.

Getting to the root: Examining within and between home health agency inequities in functional improvement.

OBJECTIVE: To quantify racial, ethnic, and income-based disparities in home health (HH) patients' functional improvement within and between HH agencies (HHAs). DATA SOURCES: 2016-2017 Outcome and Assessment Information Set, Medicare Beneficiary Summary File, and Census data. DATA COLLECTION/EXTRACTION METHODS: Not Applicable. STUDY DESIGN: We use multinomial-logit analyses with and without HHA fixed effects. The outcome is a mutually exclusive five-category outcome: (1) any functional improvement, (2) no functional improvement, (3) death while a patient, (4) transfer to an inpatient setting, and (5) continuing HH as of December 31, 2017. The adjusted outcome rates are calculated by race, ethnicity, and income level using predictive margins. PRINCIPAL FINDINGS: Of the 3+ million Medicare beneficiaries with a HH start-of-care assessment in 2016, 77% experienced functional improvement at discharge, 8% were discharged without functional improvement, 0.6% died, 2% were transferred to an inpatient setting, and 12% continued using HH. Adjusting for individual-level characteristics, Black, Hispanic, American Indian/Alaska Native (AIAN), and low-income HH patients were all more likely to be discharged without functional improvement (1.3 pp [95% CI: 1.1, 1.5], 1.5 pp [95% CI: 0.8, 2.1], 1.2 pp [95% CI: 0.6, 1.8], 0.7 pp [95% CI:0.5, 0.8], respectively) compared to White and higher income patients. After including HHA fixed effects, the differences for Black, Hispanic, and AIAN HH patients were mitigated. However, income-based disparities persisted within HHAs. Black-White, Hispanic-White, and AIAN-White disparities were largely driven by between-HHA differences, whereas income-based disparities were mostly due to within-HHA differences, and Asian American/Pacific Islander patients did not experience any observable disparities. CONCLUSIONS: Both within- and between-HHA differences contribute to the overall disparities in functional improvement. Mitigating functional improvement inequities will require a diverse set of culturally appropriate and socially conscious interventions. Improving the quality of HHAs that serve more marginalized patients and incentivizing improved equity within HHAs are approaches that are imperative for ameliorating outcomes.

Agreement of Antipsychotic Use between Nursing Home Electronic Records and Minimum Data Set.

OBJECTIVES: Nursing home (NH) Minimum Data Set (MDS) have frequently been used to measure medication use in epidemiologic studies, but there is little evidence on the accuracy of MDS-based medication records. We compared antipsychotic use estimated using 2 data sources-MDS and NH electronic medication administration records (eMAR). DESIGN: Cross-sectional comparison. SETTING AND PARTICIPANTS: This analysis was based on MDS and linked eMAR data of 604 NH residents with dementia at 54 NHs in 10 states, participating in a cluster-randomized pragmatic trial (METRIcAL), from June 2019 to February 2020. METHODS: One admission, quarterly, or annual MDS assessment was chosen for each participant. The MDS assessment recorded the number of antipsychotic treatment days during a 7-day window. We then identified antipsychotic administrations during the corresponding window in the eMAR. We used Cohen kappa to assess agreement in the proportion of participants on antipsychotics during the week and used intraclass correlation coefficient (ICC) to assess the agreement of treatment days. We further used the eMAR data as a reference to calculate validity parameters. RESULTS: A total of 29.5% of study participants were identified as antipsychotic users based on the MDS vs 28.3% based on the eMAR data (kappa value: 0.96). MDS-based average treatment duration was estimated to be 2.0, consistent with eMAR-based estimate (1.8 days, ICC: 0.96). The sensitivity was 98.8% (95% CI 95.8%-99.9%), the specificity was 97.9% (95% CI 96.1%-99.1%), the positive predictive value was 94.9% (95% CI 90.8%-97.3%), and the negative predictive value was 99.5% (95% CI 98.2%-99.9%). CONCLUSIONS AND IMPLICATIONS: Agreement between the MDS and eMAR in antipsychotic use is high, suggesting that the MDS is a valid tool to measure antipsychotic use in epidemiologic studies. Further studies with large and diverse populations are warranted to confirm our findings.

Comparative Risks of Potential Adverse Events Following COVID-19 mRNA Vaccination Among Older US Adults.

Importance: Head-to-head safety comparisons of the mRNA vaccines for SARS-CoV-2 are needed for decision making; however, current evidence generalizes poorly to older adults, lacks sufficient adjustment, and inadequately captures events shortly after vaccination. Additionally, no studies to date have explored potential variation in comparative vaccine safety across subgroups with frailty or an increased risk of adverse events, information that would be useful for tailoring clinical decisions. Objective: To compare the risk of adverse events between mRNA vaccines for COVID-19 (mRNA-1273 and BNT162b2) overall, by frailty level, and by prior history of the adverse events of interest. Design, Setting, and Participants: This retrospective cohort study was conducted between December 11, 2020, and July 11, 2021, with 28 days of follow-up following the week of vaccination. A novel linked database of community pharmacy and Medicare claims data was used, representing more than 50% of the US Medicare population. Community-dwelling, fee-for-service beneficiaries aged 66 years or older who received mRNA-1273 vs BNT162b2 as their first COVID-19 vaccine were identified. Data analysis began on October 18, 2022. Exposure: Dose 1 of mRNA-1273 vs BNT162b2 vaccine. Main Outcomes and Measures: Twelve potential adverse events (eg, pulmonary embolism, thrombocytopenia purpura, and myocarditis) were assessed individually. Frailty was measured using a claims-based frailty index, with beneficiaries being categorized as nonfrail, prefrail, and frail. The risk of diagnosed COVID-19 was assessed as a secondary outcome. Generalized linear models estimated covariate-adjusted risk ratios (RRs) and risk differences (RDs) with 95% CIs. Results: This study included 6 388 196 eligible individuals who received the mRNA-1273 or BNT162b2 vaccine. Their mean (SD) age was 76.3 (7.5) years, 59.4% were women, and 86.5% were White. A total of 38.1% of individuals were categorized as prefrail and 6.0% as frail. The risk of all outcomes was low in both vaccine groups. In adjusted models, the mRNA-1273 vaccine was associated with a lower risk of pulmonary embolism (RR, 0.96 [95% CI, 0.93-1.00]; RD, 9 [95% CI, 1-16] events per 100 000 persons) and other adverse events in subgroup analyses (eg, 11.0% lower risk of thrombocytopenia purpura among individuals categorized as nonfrail). The mRNA-1273 vaccine was also associated with a lower risk of diagnosed COVID-19 (RR, 0.86 [95% CI, 0.83-0.87]), a benefit that was attenuated by frailty level (frail: RR, 0.94 [95% CI, 0.89-0.99]). Conclusions and Relevance: In this cohort study of older US adults, the mRNA-1273 vaccine was associated with a slightly lower risk of several adverse events compared with BNT162b2, possibly due to greater protection against COVID-19. Future research should seek to formally disentangle differences in vaccine safety and effectiveness and consider the role of frailty in assessments of COVID-19 vaccine performance.

Racial and ethnic disparities in COVID-19 booster vaccination among U.S. older adults differ by geographic region and Medicare enrollment.

Introduction: COVID-19 booster vaccines are highly effective at reducing severe illness and death from COVID-19. Research is needed to identify whether racial and ethnic disparities observed for the primary series of the COVID-19 vaccines persist for booster vaccinations and how those disparities may vary by other characteristics. We aimed to measure racial and ethnic differences in booster vaccine receipt among U.S. Medicare beneficiaries and characterize potential variation by demographic characteristics. Methods: We conducted a cohort study using CVS Health and Walgreens pharmacy data linked to Medicare claims. We included community-dwelling Medicare beneficiaries aged ≥66 years who received two mRNA vaccine doses (BNT162b2 and mRNA-1273) as of 8/1/2021. We followed beneficiaries from 8/1/2021 until booster vaccine receipt, death, Medicare disenrollment, or end of follow-up (12/31/2021). Adjusted Poisson regression was used to estimate rate ratios (RRs) and 95% confidence intervals (CIs) comparing vaccine uptake between groups. Results: We identified 11,339,103 eligible beneficiaries (mean age 76 years, 60% female, 78% White). Overall, 67% received a booster vaccine (White = 68.5%; Asian = 67.0%; Black = 57.0%; Hispanic = 53.3%). Compared to White individuals, Black (RR = 0.78 [95%CI = 0.78-0.78]) and Hispanic individuals (RR = 0.72 [95% = CI 0.72-0.72]) had lower rates of booster vaccination. Disparities varied by geographic region, urbanicity, and Medicare plan/Medicaid eligibility. The relative magnitude of disparities was lesser in areas where vaccine uptake was lower in White individuals. Discussion: Racial and ethnic disparities in COVID-19 vaccination have persisted for booster vaccines. These findings highlight that interventions to improve vaccine uptake should be designed at the intersection of race and ethnicity and geographic location.

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.

Medicare Advantage Patterns of Poststroke Discharge to an Inpatient Rehabilitation or Skilled Nursing Facility: A Consideration of Demographic, Functional, and Payer Factors.

OBJECTIVE: The purpose of this study was to determine the factors influencing the discharge to an inpatient rehabilitation facility (IRF) or a skilled nursing facility (SNF) of people poststroke with Medicare Advantage plans. METHODS: A retrospective cohort study was conducted with data from naviHealth, a company that manages postacute care discharge placement on behalf of Medicare Advantage organizations. The dependent variable was discharge destination (IRF or SNF). Variables included age, sex, prior living setting, functional status (Activity Measure for Post-Acute Care [AM-PAC]), acute hospital length of stay, comorbidities, and payers (health plans). Analysis estimated relative risk (RR) of discharge to SNF, while controlling for regional variation. RESULTS: Individuals discharged to an SNF were older (RR = 1.17), women (RR = 1.05), lived at home alone or in assisted living (RR = 1.13 and 1.39, respectively), had comorbidities impacting their function "some" or "severely" (RR = 1.43 and 1.81, respectively), and had a length of stay greater than 5 days (RR = 1.16). Individuals with better AM-PAC Basic Mobility (RR = 0.95) went to an IRF, and individuals with better Daily Activity (RR = 1.01) scores went to an SNF. There was a substantial, significant variation in discharge of individuals to SNF by payer group (RR range = 1.12-1.92). CONCLUSIONS: The results of this study show that individuals poststroke are more likely to be discharged to an SNF than to an IRF. This study did not find a different discharge decision-making picture for those with Medicare Advantage plans than previously described for other insurance programs. IMPACT: Medicare Advantage payers have varied patterns in discharge placement to an IRF or SNF for patients poststroke.

Potentially More Out of Reach: Public Reporting Exacerbates Inequities in Home Health Access.

Policy Points Public reporting is associated with both mitigating and exacerbating inequities in high-quality home health agency use for marginalized groups. Ensuring equitable access to home health requires taking a closer look at potentially inequitable policies to ensure that these policies are not inadvertently exacerbating disparities as home health public reporting potentially does. Targeted federal, state, and local interventions should focus on raising awareness about the five-star quality ratings among marginalized populations for whom inequities have been exacerbated. CONTEXT: Literature suggests that public reporting of quality may have the unintended consequence of exacerbating disparities in access to high-quality, long-term care for older adults. The objective of this study is to evaluate the impact of the home health five-star ratings on changes in high-quality home health agency use by race, ethnicity, income status, and place-based factors. METHODS: We use data from the Outcome and Assessment Information Set, Medicare Enrollment Files, Care Compare, and American Community Survey to estimate differential access to high-quality home health agencies between July 2014 and June 2017. To estimate the impact of the home health five-star rating introduction on the use of high-quality home health agencies, we use a longitudinal observational pretest-posttest design. FINDINGS: After the introduction of the home health five-star ratings in 2016, we found that adjusted rates of high-quality home health agency use increased for all home health patients, except for Hispanic/Latine and Asian American/Pacific Islander patients. Additionally, we found that the disparity in high-quality home health agency use between low-income and higher-income home health patients was exacerbated after the introduction of the five-star quality ratings. We also observed that patients within predominantly Hispanic/Latine neighborhoods had a significant decrease in their use of high-quality home health agencies, whereas patients in predominantly White and integrated neighborhoods had a significant increase in high-quality home health agency use. Other neighborhoods experience a nonsignificant change in high-quality home health agency use. CONCLUSIONS: Policymakers should be aware of the potential unintended consequences for implementing home health public reporting, specifically for Hispanic/Latine, Asian American/Pacific Islander, and low-income home health patients, as well as patients residing in predominantly Hispanic/Latine neighborhoods. Targeted interventions should focus on raising awareness around the five-star ratings.

Resident Factors Associated With Breakthrough SARS-CoV-2 Infections.

OBJECTIVE: To examine incidence of and resident characteristics associated with breakthrough infections (BTIs) and severe illness among residents with 2 messenger RNA (mRNA) vaccinations. DESIGN: Retrospective cohort study. SETTING AND PARTICIPANTS: Nursing home (NH) residents who completed their primary series of mRNA COVID-19 vaccination by March 31, 2021. METHODS: Electronic health records and Minimum Data Set assessments from a multistate NH data consortium were used to identify BTI and severe illness (a composite measure of hospitalization and/or death within 30 days of BTI) occurring prior to November 24, 2021. A t test for differences in means was used to compare covariates for residents with and without BTI. Finally, we estimated incidence rate ratios (IRRs) for BTI with 95% CIs using a modified Poisson regression approach, comparing residents with BTI vs residents without. We adjusted for facility fixed effects in our model. RESULTS: Our sample included 23,172 residents from 984 NHs who were at least 14 days past their second mRNA vaccine dose. Of those, 1173 (5%) developed an incident COVID-19 BTI (mean follow-up time: 250 days). Among residents with BTI, 8.6% were hospitalized or died within 30 days of BTI diagnosis. Factors associated with severe illness included age ≥85 years (IRR 2.08, 95% CI 1.08-4.02, reference age <65 years), bowel incontinence (IRR 1.73, 95% CI 1.01-2.99), coronary artery disease (IRR 1.96, 95% CI 1.31-2.94), chronic kidney disease (IRR 1.65, 95% CI 1.07-2.54), and schizophrenia (IRR 2.38, 95% CI 1.19-4.75). CONCLUSIONS AND IMPLICATIONS: Among vaccinated NH residents, BTIs and associated severe illness are rare. Residents aged ≥85 years and with certain comorbidities appear to be the most vulnerable. Given that the pandemic continues and testing policies have relaxed, these data provide prognostic information for NH facilities faced with continued outbreaks.

Risk of Discharge to Lower-Quality Nursing Homes Among Hospitalized Older Adults With Alzheimer Disease and Related Dementias.

Importance: Individuals with Alzheimer disease and related dementias (ADRD) frequently require skilled nursing facility (SNF) care following hospitalization. Despite lower SNF incentives to care for the ADRD population, knowledge on how the quality of SNF care differs for those with vs without ADRD is limited. Objective: To examine whether persons with ADRD are systematically admitted to lower-quality SNFs. Design, Setting, and Participants: Cross-sectional analysis of Medicare beneficiaries hospitalized between January 1, 2017, and December 31, 2019, was conducted. Data analysis was performed from January 15 to May 30, 2022. Participants were discharged to a Medicare-certified SNF from a general acute hospital. Patients younger than 65 years, enrolled in Medicare Advantage, and with prior SNF or long-term nursing home use within 1 year of hospitalization were excluded. Exposures: The quality level of all SNFs available at the patient's discharge, measured using publicly reported 5-star staffing ratings. The 5-star ratings were grouped into 3 levels (1-2 stars [reference category, low-quality], 3 stars [average-quality], and 4-5 stars [high-quality]). Main Outcomes and Measures: The outcome was the SNF a patient entered among the possible SNF destinations available at discharge. Differences in the association between SNF quality and SNF entry for patients with and without ADRD were assessed using a conditional logit model, which simultaneously controls for differences in discharging hospital, residential neighborhood, and the other characteristics (eg, postacute care specialization) of all SNFs available at discharge. Results: The sample included 2 619 464 patients (mean [SD] age, 81.3 [8.6] years; 61% women; 87% were White; 8% were Black; 22% with ADRD). The probability of discharge to higher quality SNFs was lower for patients with ADRD. If the star rating of an SNF was high instead of low, the log-odds of being discharged to it increased by 0.31 for patients with ADRD and by 0.47 for those without ADRD (difference, -0.16; P < .001). The weaker association between quality and entry for patients with ADRD indicates that they are less likely to be discharged to high-quality SNFs. Conclusions and Relevance: The findings of this study suggest that patients with ADRD are more likely to be discharged to lower-quality SNFs. Targeted reforms, such as ADRD-specific compensation adjustments, may be needed to improve access to better SNFs for patients with ADRD.

Differences In Nursing Home Staff COVID-19 Testing Rates And Odds Of Vaccination Across Work Shifts.

COVID-19 vaccination and regular testing of nursing home staff have been critical interventions for mitigating COVID-19 outbreaks in US nursing homes. Although implementation of testing has largely been left to nursing home organizations to coordinate, vaccination occurred through a combination of state, federal, and organization efforts. Little research has focused on structural variation in these processes. We examined whether one structural factor, the primary shift worked by staff, was associated with differences in COVID-19 testing rates and odds of vaccination, using staff-level data from a multistate sample of 294 nursing homes. In facility fixed effects analyses, we found that night-shift staff had the lowest testing rates and lowest odds of vaccination, whereas day-shift staff had the highest testing rates and odds of vaccination. These findings highlight the need to coordinate resources and communication evenly across shifts when implementing large-scale processes in nursing homes and other organizations with shift-based workforces.

Intervention delivery for embedded pragmatic clinical trials: Development of a tool to measure complexity.

BACKGROUND: Conducting an embedded pragmatic clinical trial in the workflow of a healthcare system is a complex endeavor. The complexity of the intervention delivery can have implications for study planning, ability to maintain fidelity to the intervention during the trial, and/or ability to detect meaningful differences in outcomes. METHODS: We conducted a literature review, developed a tool, and conducted two rounds of phone calls with NIH Pragmatic Trials Collaboratory Demonstration Project principal investigators to develop the Intervention Delivery Complexity Tool. After refining the tool, we piloted it with Collaboratory demonstration projects and developed an online version of the tool using the R Shiny application (https://duke-som.shinyapps.io/ICT-ePCT/). RESULTS: The 6-item tool consists of internal and external factors. Internal factors pertain to the intervention itself and include workflow, training, and the number of intervention components. External factors are related to intervention delivery at the system level including differences in healthcare systems, the dependency on setting for implementation, and the number of steps between the intervention and the outcome. CONCLUSION: The Intervention Delivery Complexity Tool was developed as a standard way to overcome communication challenges of intervention delivery within an embedded pragmatic trial. This version of the tool is most likely to be useful to the trial team and its health system partners during trial planning and conduct. We expect further evolution of the tool as more pragmatic trials are conducted and feedback is received on its performance outside of the NIH Pragmatic Trials Collaboratory.

Unmet Needs and Associated Factors among Community-living Older People with Disability in China: 2005-2014.

Based on the Chinese Longitudinal Healthy Longevity Survey from 2005 to 2014, this study estimated the prevalence and examined risk factors of under-met needs and completely unmet needs for assistance in activities of daily living (ADLs) among community-living older people with disability in China. As of 2014, over 50% of community-living Chinese elders with disability experienced under-met needs, and nearly 5% had completely unmet needs. From 2005 to 2014, the proportion with completely unmet needs doubled for all disabled elders. Significant risk factors of under-met needs included lower per capita annual household income, more ADL limitations, living alone, and fewer living children, and those of completely unmet needs included less ADL limitations and living alone. More policy attention should be paid to address the gap between long-term care services for older persons with severe disability and supportive services for those who are relatively healthy, toward ultimately establishing a care continuum for the elderly at all stages of their life course. In addition, family care for elders with severe functional impairments should be supplemented by professional long-term care services to best meet their needs.