Leveraging home health aides to improve outcomes in heart failure: A pilot study protocol.

Heart failure (HF) affects six million people in the U.S., is associated with high morbidity, mortality, and healthcare utilization.(1, 2) Despite a decade of innovation, the majority of interventions aimed at reducing hospitalization and readmissions in HF have not been successful.(3-7) One reason may be that most have overlooked the role of home health aides and attendants (HHAs), who are often highly involved in HF care.(8-13) Despite their contributions, studies have found that HHAs lack specific HF training and have difficulty reaching their nursing supervisors when they need urgent help with their patients. Here we describe the protocol for a pilot randomized control trial (pRCT) assessing a novel stakeholder-engaged intervention that provides HHAs with a) HF training (enhanced usual care arm) and b) HF training plus a mobile health application that allows them to chat with a nurse in real-time (intervention arm). In collaboration with the VNS Health of New York, NY, we will conduct a single-site parallel arm pRCT with 104 participants (HHAs) to evaluate the feasibility, acceptability, and effectiveness (primary outcomes: HF knowledge; HF caregiving self-efficacy) of the intervention among HHAs caring for HF patients. We hypothesize that educating and better integrating HHAs into the care team can improve their ability to provide support for patients and outcomes for HF patients as well (exploratory outcomes include hospitalization, emergency department visits, and readmission). This study offers a novel and potentially scalable way to leverage the HHA workforce and improve the outcomes of the patients for whom they care. Clinical trial.gov registration: NCT04239911.

Practice Facilitation and Peer Coaching for Uncontrolled Hypertension Among Black Individuals: A Randomized Clinical Trial.

Importance: Rural Black participants need effective intervention to achieve better blood pressure (BP) control. Objective: Among Black rural adults with persistently uncontrolled hypertension attending primary care clinics, to determine whether peer coaching (PC), practice facilitation (PF), or both (PCPF) are superior to enhanced usual care (EUC) in improving BP control. Design, Setting, and Participants: A cluster randomized clinical trial was conducted in 69 rural primary care practices across Alabama and North Carolina between September 23, 2016, and September 26, 2019. The participating practices were randomized to 4 groups: PC plus EUC, PF plus EUC, PCPF plus EUC, and EUC alone. The baseline EUC approach included a laptop for each participating practice with hyperlinks to participant education on hypertension, a binder of practice tips, a poster showing an algorithm for stepped care to improve BP, and 25 home BP monitors. The trial was stopped on February 28, 2021, after final data collection. The study included Black participants with persistently uncontrolled hypertension. Data were analyzed from February 28, 2021, to December 13, 2022. Interventions: Practice facilitators helped practices implement at least 4 quality improvement projects designed to improve BP control throughout 1 year. Peer coaches delivered a structured program via telephone on hypertension self-management throughout 1 year. Main Outcomes and Measures: The primary outcome was the proportion of participants in each trial group with BP values of less than 140/90 mm Hg at 6 months and 12 months. The secondary outcome was a change in the systolic BP of participants at 6 months and 12 months. Results: A total of 69 practices were randomized, and 1209 participants' data were included in the analysis. The mean (SD) age of participants was 58 (12) years, and 748 (62%) were women. In the intention-to-treat analyses, neither intervention alone nor in combination improved BP control or BP levels more than EUC (at 12 months, PF vs EUC odds ratio [OR], 0.94 [95% CI, 0.58-1.52]; PC vs EUC OR, 1.30 [95% CI, 0.83-2.04]; PCPF vs EUC OR, 1.02 [95% CI, 0.64-1.64]). In preplanned subgroup analyses, participants younger than 60 years in the PC and PCPF groups experienced a significant 5 mm Hg greater reduction in systolic BP than participants younger than 60 years in the EUC group at 12 months. Practicewide BP control estimates in PF groups suggested that BP control improved from 54% to 61%, a finding that was not observed in the trial's participants. Conclusions and Relevance: The results of this cluster randomized clinical trial demonstrated that neither PC nor PF demonstrated a superior improvement in overall BP control compared with EUC. However, PC led to a significant reduction in systolic BP among younger adults. Trial Registration: ClinicalTrials.gov Identifier: NCT02866669.

The association between social functioning and health literacy among rural Southeastern African Americans with hypertension.

African Americans living in low socioeconomic circumstances are at high risk of poor health outcomes; this is particularly true for those with hypertension. Many African Americans with chronic hypertension living in the rural impoverished Southeastern USA have low health literacy and are socially isolated. These factors are known to have a negative impact on health outcomes, but it is possible that social support may overcome some of the effect of low health literacy. Since little has been reported about this association, we examined the association between social functioning and health literacy in a rural African American population in the Southeast USA. We used baseline data from participants in the Southeastern Collaboration to Improve Blood Pressure Control, a pragmatic trial that recruited rural African Americans with persistently uncontrolled hypertension and collected survey data. Overall, 33.5% of the 1221 person sample reported social isolation, 26.0% reported low instrumental support, 36.0% reported low emotional support, and 63.4% had inadequate health literacy. All three domains of low social functioning were significantly associated with low health literacy, and this effect was robust to multivariable adjustment for sociodemographics and cognitive functioning for social isolation (adjusted odds ratio 1.62, 95% confidence intervals 1.20-2.20). In conclusion, the majority of this sample living in the NC and AL Black Belt had high social functioning but inadequate health literacy. Tests of interventions to improve social support, especially social isolation, may be warranted to overcome low health literacy in this high-risk rural population.

The design and rationale of a multicenter real-world trial: The Southeastern Collaboration to Improve Blood Pressure Control in the US Black Belt - Addressing the Triple Threat.

BACKGROUND: Impoverished African Americans (AA) with hypertension face poor health outcomes. PURPOSE: To conduct a cluster-randomized trial testing two interventions, alone and in combination, to improve blood pressure (BP) control in AA with persistently uncontrolled hypertension. METHODS: We engaged primary care practices serving rural Alabama and North Carolina residents, and in each practice we recruited approximately 25 AA adults with persistently uncontrolled hypertension (mean systolic BP >140 mmHg over the year prior to enrollment plus enrollment day BP assessed by research assistants ≥140/90 mmHg). Practices were randomized to peer coaching (PC), practice facilitation (PF), both PC and PF (PC + PF), or enhanced usual care (EUC). Coaches met with participants from PC and PC + PF practices weekly for 8 weeks then monthly over one year, discussing lifestyle changes, medication adherence, home monitoring, and communication with the healthcare team. Facilitators met with PF and PC + PF practices monthly to implement ≥1 quality improvement intervention in each of four domains. Data were collected at 0, 6, and 12 months. RESULTS: We recruited 69 practices and 1596 participants; 18 practices (408 participants) were randomized to EUC, 16 (384 participants) to PF, 19 (424 participants) to PC, and 16 (380 participants) to PC + PF. Participants had mean age 57 years, 61% were women, and 56% reported annual income <$20,000. LIMITATIONS: The PF intervention acts at the practice level, possibly missing intervention effects in trial participants. Neither PC nor PF currently has established clinical reimbursement mechanisms. CONCLUSIONS: This trial will fill evidence gaps regarding practice-level vs. patient-level interventions for rural impoverished AA with uncontrolled hypertension.

Risk for cardiovascular events following 'microsize' versus usual myocardial infarctions.

BACKGROUND: Microsize myocardial infarction (MI) is a recently described phenomenon that meets rigorous criteria for MI with very low peak troponin elevations. We aim to compare the risk for cardiovascular events and mortality following microsize versus usual MIs. METHODS AND RESULTS: Prospective cohort analysis of REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants without a history of coronary heart disease (CHD) who had an incident MI between 2003 and 2015. Incident MIs were classified as microsize MI (peak troponin <0.5 ng/mL) or usual MI (peak troponin ≥0.5 ng/mL). Participants were followed for a composite of cardiovascular events that included recurrent MI, coronary revascularisation, fatal CHD and heart failure, and all-cause mortality. Overall, 1024 participants with an incident MI were included in the analysis (328 with microsize MI and 696 with usual MI). Participants with microsize MI were more likely to be older and black. The multivariable-adjusted adjustment HR for cardiovascular events among participants with microsize versus usual MI after a median follow-up of 1.7 years was 1.11 (95% CI 0.86 to 1.44). The multivariable-adjusted HR for all-cause mortality after 28 days from incident MI among participants with microsize versus usual MI after a median follow-up of 3.6 years was 1.09 (95% CI 0.81 to 1.45). CONCLUSION: Microsize MIs have a prognostic value for future cardiovascular events and mortality comparable to usual MIs. These findings should encourage clinicians to initiate secondary prevention strategies in patients with microsize MI until this emerging clinical entity is better understood.

Relation of a Simple Cardiac Co-Morbidity Count and Cardiovascular Readmission After a Heart Failure Hospitalization.

Although several risk calculators are available to determine risk for readmission following a heart failure (HF) hospitalization, none provide information on cause-specific readmission. Understanding risk for cause-specific readmission could aid in developing a targeted approach to reducing readmissions. We sought to determine if a simple cardiac co-morbidity count could identify individuals at high risk for a cardiovascular (CV) readmission following a HF hospitalization. Using the Nationwide Readmissions Database, we examined nonfatal hospital discharges with a principal diagnosis of HF. We calculated a 0 to 3 cardiac co-morbidity count based on the presence of coronary artery disease, atrial arrhythmia, and/or ventricular arrhythmia. We used a multinomial logistic regression to determine if the cardiac co-morbidity count was independently associated with CV readmission or non-CV readmission, adjusting for patient- and hospital-level confounders. In 380,075 discharges, 28% had a co-morbidity count of 0, 47% had a count of 1, 23% had a count of 2, and 2% had a count of 3. In a fully adjusted model, cardiac co-morbidity count was independently associated with CV readmission: compared with individuals with a count of 0, the relative risk for those with a count of 1 was 1.27 (95% confidence interval [CI]: 1.23 to 1.31); for those with a count of 2 was 1.40 (95% CI: 1.35 to 1.46); and for those with a count of 3 was 1.36 (95% CI: 1.23 to 1.51). Cardiac co-morbidity count was not independently associated with non-CV readmission. In conclusion, we found that a simple cardiac co-morbidity count was independently associated with increased risk of CV but not non-CV readmission.

Impact of diagnostic bone biopsies on the management of non-vertebral osteomyelitis: A retrospective cohort study.

Optimal antibiotic management of patients with osteomyelitis remains a challenge for many clinicians. Although image-guided bone biopsy (IGB) remains the gold standard, its role in confirming diagnosis and guiding antibiotic management is not clear in patients with non-vertebral osteomyelitis.To determine the diagnostic yield of IGB and its impact on antibiotic management in non-vertebral osteomyelitis.Retrospective cohort study.Urban academic medical center.Patients admitted for non-vertebral osteomyelitis who underwent image-guided bone biopsy.Primary outcomes were microbiologic and histopathological results. We evaluated the impact of IGB on clinician-initiated changes in antibiotic regimen before and after biopsy.We evaluated 203 bone biopsies in 185 patients with clinical suspicion of osteomyelitis. 79% of patient received antibiotics prior to biopsy. Bone cultures were positive in 28% and histopathology confirmed osteomyelitis in 29%, but concordance was poor. Furthermore, clinical suspicion of infection was much higher, given that 68% received empiric antibiotics. Leukocytosis was significantly associated with positive cultures in multivariate analysis. There was no statistically significant correlation between antibiotic management and bone culture results. When culture yielded an organism, empiric regimens were kept the same, broadened or narrowed with equal frequency; targeted regimens were chosen only in 4 cases. Despite negative cultures in 98/138 cases having received empiric treatment, antibiotics were discontinued in only 8 cases. Even when empiric treatment was not given, negative cultures did not dissuade clinicians from eventual antibiotic use in a significant number of cases (17/48). In 46/71 patients whose final regimen included vancomycin, there was no evidence of current or past infection with MRSA.In patients with non-vertebral osteomyelitis, the diagnostic yield of image-guided bone biopsy is low, and clinicians frequently make decisions regarding antibiotic management that are not aligned with culture results.

Prevalence and determinants of Hyperpolypharmacy in adults with heart failure: an observational study from the National Health and Nutrition Examination Survey (NHANES).

BACKGROUND: While an expanding armamentarium of pharmacologic therapies has contributed to improved outcomes among adults with heart failure (HF) over the past two decades, this has also been accompanied by an increase in the number of medications taken by adults with HF. The use of at least 10 medications, defined as hyperpolypharmacy, is particularly notable given its association with adverse outcomes. We aimed to assess the prevalence and identify determinants of hyperpolypharmacy among adults with HF. METHODS: We studied adults aged ≥50 years with self-reported HF from the National Health And Nutrition Examination Survey (NHANES) in 2003-2014. We calculated weighted means and percentages to describe patient characteristics. We conducted a multivariable Poisson regression analysis to identify factors independently associated with hyperpolypharmacy; we adjusted for survey sampling, socio-demographics, comorbidity, geriatric conditions, and health care utilization. We examined 947 participants, representing 4.6 million adults with HF. RESULTS: The prevalence of hyperpolypharmacy was 26%. In a multivariable regression analysis, comorbidity count, ≥10 ambulatory contacts, and ≥ 3 hospitalizations were independently associated with hyperpolypharmacy. Interestingly, functional impairment and cognitive impairment were not independently associated with hyperpolypharmacy; while low annual household income and low educational status were each associated with an almost 2-fold increase in hyperpolypharmacy. CONCLUSION: Hyperpolypharmacy is a common condition among adults with HF. We additionally found that low household income and low educational status are independently associated with hyperpolypharmacy, suggesting that non-medical factors may be contributing to this potentially harmful condition.

Risk factors for 'microsize' vs. usual myocardial infarctions in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study.

AIMS: A recently described phenomenon is that of myocardial infarction (MI) events that meet criteria for MI, but that have very low peak troponin elevations, so-called 'microsize MI'. These events are very common and associated with increased risk of all-cause mortality. Our aim is to compare risk factors for microsize MI vs. usual MI events. METHODS AND RESULTS: Among 24 470 participants of the Reasons for Geographic and Racial Differences in Stroke (REGARDS) cohort free of coronary heart disease at baseline, heart-related hospitalizations were expert adjudicated for MI using published guidelines. Myocardial infarctions were classified as microsize MI (peak troponin <0.5 ng/mL) or usual MI (peak troponin ≥0.5 ng/mL). Competing risk analyses assessed associations between baseline risk factors and incident microsize vs. usual MI. Between 2003 and 2013 there were 891 MIs; 279 were microsize MI and 612 were usual MI. Risk factors for both usual MI and microsize MI include age, gender, diabetes, and urinary albumin to creatinine ratio. Risk factors for only usual MI include Residence in the Stroke Belt and Buckle regions and current smoking. Black race was associated with a uniquely lower risk of usual MI. CONCLUSION: The similarities in risk profiles suggest a possible common aetiology and should encourage clinicians to both treat reversible risk factors for microsize MI and to initiate secondary prevention strategies following these events until this emerging clinical entity is better understood. Future studies should further assess the clinical outcomes of these two entities and their effect on future management.

Evaluating Gaps in Care of Malnourished Patients on General Medicine Floors in an Acute Care Setting.

BACKGROUND: As described in detail in the literature, patients identified with malnutrition are at increased risk for poor clinical outcomes. Despite this knowledge, malnourished patients do not always receive optimal nutrition management while admitted into a hospital because of what we describe as gaps in care throughout their admission. We hypothesized that the 3 main gaps in care were poor dietitian-doctor communication, excessive time spent nil per os (NPO) for procedures and testing, and/or inaccurate or incomplete dietary discharge instructions. The objectives of this study were to determine and to characterize gaps in nutrition care after a malnutrition diagnosis. METHODS: This retrospective study involved postdischarge chart reviews of malnourished adult medicine patients admitted to an acute care facility from September 1, 2014, to November 30, 2014 (n = 242). RESULTS: Of the malnourished patients, 76% had at least 1 gap in care. The most prevalent gap (68%) involved discharge diet instructions, most often because of the omission of the dietitian recommendation for oral supplementation. Thirty-five percent of malnourished patients had a gap in care because of procedures or testing extending the period held NPO, and 13% had a gap in care because of poor communication, thus delaying orders and/or interventions. CONCLUSIONS: This is the first study to evaluate gaps in care of patients diagnosed with malnutrition. Identification of these gaps allows us the opportunity to develop strategies for this vulnerable population to improve areas such as discharge documentation and time spent NPO to provide the best and safest nutrition care.

Association Between Functional Impairment and Medication Burden in Adults with Heart Failure.

OBJECTIVES: To determine whether the number of medications taken by adults with heart failure (HF) and impairment in activities of daily living (ADL)-a subpopulation in whom the risks of a high medication burden may outweigh the benefits-differs from the number taken by those without impairment in ADLs. DESIGN: Cross-sectional. SETTING: National Health and Nutrition Examination Survey (NHANES; 2003-2014), a cross-sectional survey that produces national estimates of adults in the United States. PARTICIPANTS: Adults aged 50 and older (mean 70) with self-reported HF (N= 947; representing 4.6 million adults with HF in the United States. MEASURMENTS: We assessed ADL impairment and medication count based on self-report. ADL impairment was defined as having difficulty with or being unable to dress, feed oneself, or get in and out of bed. To determine the independent association between ADL impairment and medication count, we performed sequential Poisson multivariable regression analyses. All analyses were cross-sectional in nature and accounted for the complex survey design of NHANES. RESULTS: Mean medication count was 7.2, and 74% of participants were taking 5 or more medications (polypharmacy). In a multivariable model, ADL impairment was not independently associated with medication count. These findings were similar for those with 3 or more hospitalizations in the prior year, declining health status, and cognitive impairment. CONCLUSION: After adjusting for confounders including comorbidity, we found that adults with HF and ADL impairment take as many medications as those without ADL impairment. This suggests that providers may not sufficiently consider functional impairment when prescribing medications to adults with HF and thus may unnecessarily expose individuals to risk of adverse outcomes. J Am Geriatr Soc 67:284-291, 2019.

The Prevalence of Cognitive Impairment Among Adults With Incident Heart Failure: The "Reasons for Geographic and Racial Differences in Stroke" (REGARDS) Study.

BACKGROUND: Cognitive impairment (CI) is estimated to be present in 25%-80% of heart failure (HF) patients, but its prevalence at diagnosis is unclear. To improve our understanding of cognition in HF, we determined the prevalence of CI among adults with incident HF in the REGARDS study. METHODS AND RESULTS: REGARDS is a longitudinal cohort study of adults ≥45 years of age recruited in the years 2003-2007. Incident HF was expert adjudicated. Cognitive function was assessed with the Six-Item Screener. The prevalence of CI among those with incident HF was compared with the prevalence of CI among an age-, sex-, and race-matched cohort without HF. The 436 participants with incident HF had a mean age of 70.3 years (SD 8.9), 47% were female, and 39% were black. Old age, black race, female sex, less education, and anticoagulation use were associated with CI. The prevalence of CI among participants with incident HF (14.9% [95% CI 11.7%-18.6%]) was similar to the non-HF matched cohort (13.4% [11.6%-15.4%]; P < .43). CONCLUSIONS: A total of 14.9% of the adults with incident HF had CI, suggesting that the majority of cognitive decline occurs after HF diagnosis. Increased awareness of CI among newly diagnosed patients and ways to mitigate it in the context of HF management are warranted.

Dietary Patterns and Mediterranean Diet Score and Hazard of Recurrent Coronary Heart Disease Events and All-Cause Mortality in the REGARDS Study.

BACKGROUND: Previously, we reported on associations between dietary patterns and incident acute coronary heart disease (CHD) in the REGARDS (Reasons for Geographic and Racial Differences in Stroke) study. Here, we investigated the associations of dietary patterns and a dietary index with recurrent CHD events and all-cause mortality in REGARDS participants with existing CHD. METHODS AND RESULTS: We included data from 3562 participants with existing CHD in REGARDS. We used Cox proportional hazards regression to examine the hazard of first recurrence of CHD events-definite or probable MI or acute CHD death-and all-cause mortality associated with quartiles of empirically derived dietary patterns (convenience, plant-based, sweets, Southern, and alcohol and salads) and the Mediterranean diet score. Over a median 7.1 years (interquartile range, 4.4, 8.9 years) follow-up, there were 581 recurrent CHD events and 1098 deaths. In multivariable-adjusted models, the Mediterranean diet score was inversely associated with the hazard of recurrent CHD events (hazard ratio for highest score versus lowest score, 0.78; 95% confidence interval, 0.62-0.98; PTrend=0.036). The Southern dietary pattern was adversely associated with the hazard of all-cause mortality (hazard ratio for Q4 versus Q1, 1.57; 95% confidence interval, 1.28-1.91; PTrend<0.001). The Mediterranean diet score was inversely associated with the hazard of all-cause mortality (hazard ratio for highest score versus lowest score, 0.80; 95% confidence interval, 0.67-0.95; PTrend=0.014). CONCLUSIONS: The Southern dietary pattern was associated with a greater hazard of all-cause mortality in REGARDS participants. Greater adherence to the Mediterranean diet was associated with both a lower hazard of recurrent CHD events and all-cause mortality.

N-terminal pro-B-type natriuretic peptide and microsize myocardial infarction risk in the reasons for geographic and racial differences in stroke study.

BACKGROUND: N-terminal pro B-type peptide (NT-proBNP) has been associated with risk of myocardial infarction (MI), but less is known about the relationship between NT-proBNP and very small non ST-elevation MI, also known as microsize MI. These events are now routinely detectable with modern troponin assays and are emerging as a large proportion of all MI. Here, we sought to compare the association of NT-proBNP with risk of incident typical MI and microsize MI in the REasons for Geographic and Racial Differences in Stroke (REGARDS) Study. METHODS: The REGARDS Study is a national cohort of 30,239 US community-dwelling black and white adults aged ≥ 45 years recruited from 2003 to 2007. Expert-adjudicated outcomes included incident typical MI (definite/probable MI with peak troponin ≥ 0.5 µg/L), incident microsize MI (definite/probable MI with peak troponin < 0.5 µg/L), and incident fatal CHD. Using a case-cohort design, we estimated the hazard ratio of the outcomes as a function of baseline NT-proBNP. Competing risk analyses tested whether the associations of NT-proBNP differed between the risk of incident microsize MI and incident typical MI as well as if the association of NT-proBNP differed between incident non-fatal microsize MI and incident non-fatal typical MI, while accounting for incident fatal coronary heart disease (CHD) as well as heart failure (HF). RESULTS: Over a median of 5 years of follow-up, there were 315 typical MI, 139 microsize MI, and 195 incident fatal CHD. NT-proBNP was independently and strongly associated with all CHD endpoints, with significantly greater risk observed for incident microsize MI, even after removing individuals with suspected HF prior to or coincident with their incident CHD event. CONCLUSION: NT-proBNP is associated with all MIs, but is a more powerful risk factor for microsize than typical MI.