A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

BACKGROUND: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined. METHODS: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group. RESULTS: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups. CONCLUSIONS: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).

Approach to Multimorbidity Burden Classification and Outcomes in Older Adults With Heart Failure.

BACKGROUND: The optimal approach to classifying multimorbidity burden in assessing treatment-associated outcomes using real-world data remains uncertain. We assessed whether 2 measurement approaches to characterize multimorbidity influenced observed associations of ß-blocker use with outcomes in adults with heart failure (HF). METHODS: We conducted a retrospective study on adults with HF from 4 integrated health care delivery systems. Multimorbidity burden was characterized by either (1) simple counts of chronic conditions or (2) a weighted multiple chronic conditions score using data from electronic health records. We assessed the impact of these 2 approaches to characterizing multimorbidity on associations between exposure to ß-blockers and subsequent all-cause death, hospitalization for HF, and hospitalization for any cause. RESULTS: The study population characterized by a count of chronic conditions included 9988 adults with HF who had a mean (SD) age of 76.4 (12.5) years, with 48.7% women and 24.7% racial/ethnic minorities. The cohort characterized by weighted multiple chronic conditions included 10,082 adults with HF who had a mean (SD) age of 76.4 (12.4) years, 48.9% women, and 25.5% racial/ethnic minorities. The multivariable associations of risks of death or hospitalizations for HF or for any cause associated with incident ß-blocker use were similar regardless of how multimorbidity burden was characterized. CONCLUSIONS: Simple counts of chronic conditions performed similarly to a weighted multimorbidity score in predicting outcomes using real-world data to examine clinical outcomes associated with ß-blocker therapy in HF. Our findings challenge conventional wisdom that more complex measures of multimorbidity are always necessary to characterize patients in observational studies examining therapy-associated outcomes.

Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.

BACKGROUND: There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results. Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes. METHODS: We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration's Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials. RESULTS: Information is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned. CONCLUSIONS: Studies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.

Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients.

Patient education of high-risk medications such as direct oral anticoagulants (DOACs) is limited in ambulatory care settings. Clinical pharmacists are uniquely equipped to educate patients about DOACS but seldom interact with patients in those settings where patient education and satisfaction are often overlooked. Recently, the Anticoagulation Forum endorsed a checklist (DOAC Checklist) to guide and educate patients initiating or resuming DOACs. We assessed the impact on knowledge and satisfaction of an intervention framed around the checklist. Randomized clinical trial. Ambulatory patients starting a DOAC or resuming one after setback (bleeding, stroke, or transient ischemic attack) in an ambulatory setting (office, emergency department, or short stay hospitalization). Three educational clinical pharmacist tele-visits, hotline access to the pharmacist, and coordination with continuity providers in 3 months. Patient knowledge scores from a 15-item DOAC-related questionnaire and satisfaction scores from an abbreviated version of the Duke Anticoagulation Satisfaction Survey (DASS). Of 561 randomized patients, 436 completed our follow-up surveys. Knowledge scores were similar for the 233 intervention patients vs. 203 control patients (63.7% vs 62.2% correct). Satisfaction scores on the 7-point Likert scale were virtually identical (6.24 and 6.22). Our pharmacist-led intervention framed around the DOAC checklist had little impact on knowledge and satisfaction. Delays between intervention end and completion of the follow-up questionnaires may have obscured benefits experienced earlier. More intensive education or strategies other than telephone-based consultation may be required to produce sustained knowledge.TRN: NCT04068727 retrospectively registered on August 22, 2019.

Medication cost-reducing behaviors in older adults with atrial fibrillation: The SAGE-AF study.

BACKGROUND: As patient prices for many medications have risen steeply in the United States, patients may engage in cost-reducing behaviors (CRBs) such as asking for generic medications or purchasing medication from the Internet. OBJECTIVE: The objective of this study is to describe patterns of CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications among older adults with atrial fibrillation (AF) and examine participant characteristics associated with CRB. METHODS: Data were from a prospective cohort study of older adults at least 65 years with AF and a high stroke risk (CHA2DS2VASc ≥ 2). CRB, cost-related medication nonadherence, and spending less on basic needs to afford medications were evaluated using validated measures. Chi-square and t tests were used to evaluate differences in characteristics across CRB, and statistically significant characteristics (P < 0.05) were entered into a multivariable logistic regression to examine factors associated with CRB. RESULTS: Among participants (N = 1224; mean age 76 years; 49% female), 69% reported engaging in CRB, 4% reported cost-related medication nonadherence, and 6% reported spending less on basic needs. Participants who were cognitively impaired (adjusted odds ratio 0.69 [95% CI 0.52-0.91]) and those who did not identify as non-Hispanic white (0.66 [0.46-0.95]) were less likely to engage in CRB. Participants who were married (1.88 [1.30-2.72]), had a household income of $20,000-$49,999 (1.52 [1.02-2.27]), had Medicare insurance (1.38 [1.04-1.83]), and had 4-6 comorbidities (1.43 [1.01-2.01]) had significantly higher odds of engaging in CRB. CONCLUSION: Although CRBs were common among older adults with AF, few reported cost-related medication nonadherence and spending less on basic needs. Patients with cognitive impairment may benefit from pharmacist intervention to provide support in CRB and patient assistance programs.

Trends in breast and prostate cancer screening and diagnostic procedures during the COVID-19 pandemic in central Massachusetts.

PURPOSE: We calculated rates of breast and prostate cancer screening and diagnostic procedures performed during the COVID-19 pandemic through December 2021 compared to the same months in 2019 in a large healthcare provider group in central Massachusetts. METHODS: We included active patients of the provider group between January 2019 and December 2021 aged 30-85 years. Monthly rates of screening mammography and digital breast tomosynthesis, breast MRI, total prostate specific antigen (PSA), and breast or prostate biopsy per 1,000 people were compared by year overall, by age, and race/ethnicity. Completed procedures were identified by relevant codes in electronic health record data. RESULTS: Rates of screening mammography, tomosynthesis, and PSA testing reached the lowest levels in April-May 2020. Breast cancer screening rates decreased 43% in March and 99% in April and May 2020, compared to 2019. Breast cancer screening rates increased gradually beginning in June 2020 through 2021, although more slowly in Black and Hispanic women and in women aged 75-85. PSA testing rates decreased 34% in March, 78% in April, and 53% in May 2020, but rebounded to pre-pandemic levels by June 2020; trends were similar across groups defined by age and race/ethnicity. CONCLUSION: The observed decline in two common screening procedures during the COVID-19 pandemic reflects the impact of the pandemic on cancer early detection and signals potential downstream effects on the prognosis of delayed cancer diagnoses. The slower rate of return for breast cancer screening procedures in certain subgroups should be investigated to ensure all women return for routine screenings.

Presence of Geriatric Conditions Is Prognostic of Major Bleeding in Older Patients with Atrial Fibrillation: a Cohort Study.

BACKGROUND: In older patients with atrial fibrillation (AF), physical, cognitive, and psychosocial limitations are prevalent. The prognostic value of these conditions for major bleeding is unclear. OBJECTIVE: To determine whether geriatric conditions are prospectively associated with major bleeding in older patients with AF on anticoagulation. DESIGN: Multicenter cohort study with 2-year follow-up from 2016 to 2020 in Massachusetts and Georgia from cardiology, electrophysiology, and primary care clinics. PARTICIPANTS: Diagnosed with AF, age 65 years or older, CHA2DS2-VASc score of 2 or higher, and taking oral anticoagulant (n=1,064). A total of 6507 individuals were screened. MAIN MEASURES: A six-component geriatric assessment of frailty, cognitive function, social support, depressive symptoms, vision, and hearing. Main outcome was major bleeding adjudicated by a physician panel. KEY RESULTS: At baseline, participants were, on average, 75.5 years old and 49% were women. Mean CHA2DS2-VASc score was 4.5 and the mean HAS-BLED score was 3.3. During 2.0 (± 0.4) years of follow-up, 95 (8.9%) participants developed an episode of major bleeding. After adjusting for key covariates and accounting for competing risk from death, cognitive impairment (hazard ratio [HR] 1.62, 95% confidence interval [CI]: 1.02-2.56) and frailty (HR 2.77, 95% CI 1.38-5.58) were significantly associated with the development of major bleeding. CONCLUSIONS: In older patients with AF taking anticoagulants, cognitive impairment and frailty were independently associated with major bleeding.

Advancing clinical trials in nursing homes: A proposed roadmap to success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Cost-related Medication Nonadherence and Its Risk Factors Among Medicare Beneficiaries.

BACKGROUND: Unaffordability of medications is a barrier to effective treatment. Cost-related nonadherence (CRN) is a crucial, widely used measure of medications access. OBJECTIVES: Our study examines the current national prevalence of and risk factors for CRN (eg, not filling, skipping or reducing doses) and companion measures in the US Medicare population. RESEARCH DESIGN: Survey-weighted analyses included logistic regression and trends 2006-2016. SUBJECTS: Main analyses used the 2016 Medicare Current Beneficiary Survey. Our study sample of 12,625 represented 56 million community-dwelling beneficiaries. MEASURES: Additional outcome measures were spending less on other necessities in order to pay for medicines and use of drug cost reduction strategies such as requesting generics. RESULTS: In 2016, 34.5% of enrollees under 65 years with disability and 14.4% of those 65 years and older did not take their medications as prescribed due to high costs; 19.4% and 4.7%, respectively, experienced going without other essentials to pay for medicines. Near-poor older beneficiaries with incomes $15-25K had 50% higher odds of CRN (vs. >$50K), but beneficiaries with incomes <$15K, more likely to be eligible for the Part D Low-Income Subsidy, did not have significantly higher risk. Three indicators of worse health (general health status, functional limits, and count of conditions) were all independently associated with higher risk of CRN. CONCLUSIONS: Changes in the risk profile for CRN since Part D reflect the effectiveness of targeted policies. The persistent prevalence of CRN and associated risks for sicker people in Medicare demonstrate the consequences of high cost-sharing for prescription fills.

Identifying prescribing cascades in Alzheimer's disease and related dementias: The calcium channel blocker-diuretic prescribing cascade.

PURPOSE: Prescribing cascades occur when a physician prescribes a new drug to address the side-effect of another drug. Persons with Alzheimer's disease and related dementias (ADRD) are at increased risk for prescribing cascades. Our objective was to develop an approach to estimating the proportion of calcium channel blocker-diuretic (CCB-diuretic) prescribing cascades among persons with ADRD in two U.S. health plans. METHODS: We identified patients aged ≥50 on January 1, 2017, dispensed a drug to treat ADRD in the 365-days prior to/on cohort entry date. Patients had medical/pharmacy coverage for 1 year before and through cohort entry. We excluded individuals with an institutional stay encounter in the 45 days prior to cohort entry and censored patients based on: disenrollment from coverage, death, or end of data. We identified incident and prevalent CCB use in the 183-days following cohort entry, and identified subsequent incident diuretic use among incident and prevalent CCB-users within 365-days from cohort entry. RESULTS: There were 121 538 eligible patients. Approximately 62% were female, with a mean age of 79.5 (SD ±8.6). Overall 2.1% of the cohort experienced a prevalent CCB-diuretic prescribing cascade with 1586 incident diuretic-users among 36 462 prevalent CCB-users (4.3%, 95% CI 4.1-4.6%]); and there were161 incident diuretic-users among 3304 incident CCB-users (4.9%, 95% CI 4.2-5.7%) (incident CCB-diuretic cascade). CONCLUSIONS: We describe an approach to identify prescribing cascades in persons with ADRD, which can be used to assess the proportion of prescribing cascades in large cohorts. We determined the proportion of CCB-diuretic prescribing cascades was low.

Validation of an electronic algorithm for Hodgkin and non-Hodgkin lymphoma in ICD-10-CM.

PURPOSE: Lymphoma is a health outcome of interest for drug safety studies. Studies using administrative claims data require the accurate identification of lymphoma cases. We developed and validated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)-based algorithm to identify lymphoma in healthcare claims data. METHODS: We developed a three-component algorithm to identify patients aged ≥15 years who were newly diagnosed with Hodgkin (HL) or non-Hodgkin (NHL) lymphoma from January 2016 through July 2018 among members of four Data Partners within the FDA's Sentinel System. The algorithm identified potential cases as patients with ≥2 ICD-10-CM lymphoma diagnosis codes on different dates within 183 days; ≥1 procedure code for a diagnostic procedure (e.g., biopsy, flow cytometry) and ≥1 procedure code for a relevant imaging study within 90 days of the first lymphoma diagnosis code. Cases identified by the algorithm were adjudicated via chart review and a positive predictive value (PPV) was calculated. RESULTS: We identified 8723 potential lymphoma cases via the algorithm and randomly sampled 213 for validation. We retrieved 138 charts (65%) and adjudicated 134 (63%). The overall PPV was 77% (95% confidence interval: 69%-84%). Most cases also had subtype information available, with 88% of cases identified as NHL and 11% as HL. CONCLUSIONS: Seventy-seven percent of lymphoma cases identified by an algorithm based on ICD-10-CM diagnosis and procedure codes and applied to claims data were true cases. This novel algorithm represents an efficient, cost-effective way to target an important health outcome of interest for large-scale drug safety and public health surveillance studies.

Identifying monoclonal gammopathy of undetermined significance in electronic health data.

PURPOSE: Monoclonal gammopathy of undetermined significance (MGUS) is a prevalent yet largely asymptomatic precursor to multiple myeloma. Patients with MGUS must undergo regular surveillance and testing, with few known predictors of progression. We developed an algorithm to identify MGUS patients in electronic health data to facilitate large-scale, population-based studies of this premalignant condition. METHODS: We developed a four-step algorithm using electronic health record and health claims data from men and women aged 50 years or older receiving care from a large, multispecialty medical group between 2007 and 2015. The case definition required patients to have at least two MGUS ICD-9 diagnosis codes within 12 months, at least one serum and/or urine protein electrophoresis and one immunofixation test, and at least one in-office hematology/oncology visit. Medical charts for selected cases were abstracted then adjudicated independently by two physicians. We assessed algorithm validity by positive predictive value (PPV). RESULTS: We identified 833 people with at least two MGUS diagnosis codes; 429 (52%) met all four algorithm criteria. We randomly selected 252 charts for review, including 206 from patients meeting all four algorithm criteria. The PPV for the 206 algorithm-identified charts was 76% (95% CI, 70%-82%). Among the 49 cases deemed to be false positives (24%), 33 were judged to have multiple myeloma or another lymphoproliferative condition, such as lymphoma. CONCLUSIONS: We developed a simple algorithm that identified MGUS cases in electronic health data with reasonable accuracy. Inclusion of additional steps to eliminate cases with malignant disease may improve algorithm performance.

The Paradoxical Decline of Geriatric Medicine as a Profession.

In this Viewpoint, author Jerry Gurwitz discusses the attrition of geriatric medicine as a profession, attributing it in part to societal attitudes about aging and compounded by the negative effects of lower compensation and lack of career prestige.

Primary Care Providers' Opening of Time-Sensitive Alerts Sent to Commercial Electronic Health Record InBaskets.

BACKGROUND: Time-sensitive alerts are among the many types of clinical notifications delivered to physicians' secure InBaskets within commercial electronic health records (EHRs). A delayed alert review can impact patient safety and compromise care. OBJECTIVE: To characterize factors associated with opening of non-interruptive time-sensitive alerts delivered into primary care provider (PCP) InBaskets. DESIGN AND PARTICIPANTS: We analyzed data for 799 automated alerts. Alerts highlighted actionable medication concerns for older patients post-hospital discharge (2010-2011). These were study-generated alerts sent 3 days post-discharge to InBaskets for 75 PCPs across a multisite healthcare system, and represent a subset of all urgent InBasket notifications. MAIN MEASURES: Using EHR access and audit logs to track alert opening, we performed bivariate and multivariate analyses calculating associations between patient characteristics, provider characteristics, contextual factors at the time of alert delivery (number of InBasket notifications, weekday), and alert opening within 24 h. KEY RESULTS: At the time of alert delivery, the PCPs had a median of 69 InBasket notifications and had received a median of 379.8 notifications (IQR 295.0, 492.0) over the prior 7 days. Of the 799 alerts, 47.1% were opened within 24 h. Patients with longer hospital stays (>4 days) were marginally more likely to have alerts opened (OR 1.48 [95% CI 1.00-2.19]). Alerts delivered to PCPs whose InBaskets had a higher number of notifications at the time of alert delivery were significantly less likely to be opened within 24 h (top quartile >157 notifications: OR 0.34 [95% CI 0.18-0.61]; reference bottom quartile ≤42). Alerts delivered on Saturdays were also less likely to be opened within 24 h (OR 0.18 [CI 0.08-0.39]). CONCLUSIONS: The number of total InBasket notifications and weekend delivery may impact the opening of time-sensitive EHR alerts. Further study is needed to support safe and effective approaches to care team management of InBasket notifications.

Did Medicare Part D Affect National Trends in Health Outcomes or Hospitalizations? A Time-Series Analysis.

BACKGROUND: Medicare Part D increased economic access to medications, but its effect on population-level health outcomes and use of other medical services remains unclear. OBJECTIVE: To examine changes in health outcomes and medical services in the Medicare population after implementation of Part D. DESIGN: Population-level longitudinal time-series analysis with generalized linear models. SETTING: Community. PATIENTS: Nationally representative sample of Medicare beneficiaries (n = 56,293 [unweighted and unique]) from 2000 to 2010. MEASUREMENTS: Changes in self-reported health status, limitations in activities of daily living (ADLs) (ADLs and instrumental ADLs), emergency department visits and hospital admissions (prevalence, counts, and spending), and mortality. Medicare claims data were used for confirmatory analyses. RESULTS: Five years after Part D implementation, no clinically or statistically significant reductions in the prevalence of fair or poor health status or limitations in ADLs or instrumental ADLs, relative to historical trends, were detected. Compared with trends before Part D, no changes in emergency department visits, hospital admissions or days, inpatient costs, or mortality after Part D were seen. Confirmatory analyses were consistent. LIMITATIONS: Only total population-level outcomes were studied. Self-reported measures may lack sensitivity. CONCLUSION: Five years after implementation, and contrary to previous reports, no evidence was found of Part D's effect on a range of population-level health indicators among Medicare enrollees. Further, there was no clear evidence of gains in medical care efficiencies.

Association of early post-discharge follow-up by a primary care physician and 30-day rehospitalization among older adults.

BACKGROUND: Rehospitalizations within 30 days of discharge are responsible for a large portion of healthcare spending. One approach to preventing rehospitalizations is early follow-up, usually defined as an office visit with a primary care physician within 7 days of discharge--an approach that is being incentivized by health plans. However, evidence regarding its effectiveness is limited. OBJECTIVE: We aimed to determine whether an office visit with a primary care physician within 7 days after discharge is associated with 30-day rehospitalization. DESIGN: This was an observational study set within a randomized trial. PARTICIPANTS: The study included patients age 65 and older receiving care from a multi-specialty group practice and discharged from hospital to home between 26 August 2010 and 25 August 2011. To control for confounding, we identified characteristics of patients and hospital stays that are predictive of rehospitalization, and also developed high-dimensional propensity scores. Analyses used Cox proportional hazards models and took into account varying amounts of opportunity time for office visits. MAIN MEASURES: We looked at 30-day rehospitalizations at any hospital. KEY RESULTS: Of 3,661 patients discharged to home during the study year, 707 (19.3%) were rehospitalized within 30 days. Patients receiving an office visit within 7 days numbered 1,808 (49.4%), and of these, 1,000 (27.3%) were with a primary care physician. In models predicting rehospitalization, stratified on deciles of propensity score and controlling for additional confounders, the hazard ratios associated with office visits with a primary care physician within 7 days were 0.98 (95% CI 0.80, 1.21); for visits with any physician, the hazard ratio was HR 1.04, (95% CI 0.87, 1.25). CONCLUSIONS: We found no protective effect for office visits within 7 days. Such visits may need to be specifically focused on a range of issues related to the specific reasons why patients are rehospitalized. It is likely that outpatient visits will need to be set within comprehensive transition programs.