Poor Medication Access as a Driver of Excess Heart-Failure Readmissions Among Patients Living in Economically Deprived Neighborhoods.

BACKGROUND: Patients residing in socioeconomically deprived neighborhoods experience higher hospital readmission rates after hospitalization for heart failure (HF). The role of medication access in the excessive readmissions in this group is poorly understood. This study explored patients' perspectives on medication access by individuals living in socioeconomically deprived neighborhoods who had experienced HF readmission. METHODS: We conducted semistructured in-depth interviews with 25 patients (mean age 61 ± 9 years, 96% Black, 40% women) who were readmitted with acute HF at Emory Healthcare hospitals and were living in highly deprived neighborhoods (top decile of the Social Deprivation Index). Qualitative descriptive analyses of the interviews were performed by using a multilevel coding strategy. RESULTS: Most patients (84%) highlighted medications as a driver of HF readmission. Patients' reported reasons for lack of medication access included medication costs (60%), having access to refills only through an emergency department or hospitalization (36%), limited access to transportation (12%), and limited understanding of medications' role in disease management (12%). CONCLUSION: Lack of access to medications for patients with HF who live in socioeconomically distressed neighborhoods exacerbate excess hospitalizations in this vulnerable population. This study focuses on patients' perspectives and experiences and identifies some potentially high-value areas to focus on in trying to enhance access and adherence to evidence-based therapies.

Racial Differences in Palliative Care Use in Heart Failure Decedents.

BACKGROUND: Minoritized individuals experience greater heart failure (HF) incidence and mortality rates, yet racial disparities in palliative care (PC) in HF are unknown. METHODS: This retrospective study used electronic medical records to identify adults who were hospitalized at an academic health system and died due to HF between 2012 and 2018. Using multivariable logistic regression, we examined associations between decedents' characteristics and PC consultations (PCCs). RESULTS: Of 1987 decedents, 45.8% (n = 911) received PCCs. Black decedents had 60% greater odds of receiving PCCs (OR = 1.60; 95% CI = 1.21-2.11) than whites. Median time from PCC to death was shorter among white than Black decedents (31.2 vs 51.5 days; P = .001). Mean age at death was younger among Black than white decedents (71.3 [14.8] vs 81.8 [12.3]; P < .001) and decedents of "other" races (71.3 [14.8] vs. 80.3 [10.4]; P = .001). Black decedents were more likely than whites to receive inotropes (54.4% vs 42.3%; P < .001) and to be admitted to hospitals (39.5% vs 29.7%; P < .001) and intensive care units in their last month (30.3% vs 18.3%; P < .001). CONCLUSIONS: Findings suggest greater recognition of palliative-care needs among Black individuals with HF; however, most referrals to PC occur late in the disease trajectory.

Institutional Review Boards' Assessment of Local Context: A Mixed Methods Study.

The nature of the review of local context by institutional review boards (IRBs) is vague. Requirements for single IRB review of multicenter trials create a need to better understand interpretation and implementation of local-context review and how to best implement such reviews centrally. We sought a pragmatic understanding of IRB local-context review by exploring stakeholders' attitudes and perceptions. Semistructured interviews with 26 IRB members and staff members, institutional officials, and investigators were integrated with 80 surveys of similar stakeholders and analyzed with qualitative theme-based text analysis and descriptive statistical analysis. Stakeholders described what they considered to be local context, the value of local-context review, and key processes used to implement review of local context in general and for emergency research conducted with an exception from informed consent. Concerns and potential advantages of centralized review of local context were expressed. Variability in perspectives suggests that local-context review is not a discrete process, which presents opportunities for defining pathways for single IRB review.

Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF): A Trial Providing Out-of-Pocket Costs for Heart Failure Medications during Clinical Encounters.

BACKGROUND: Evidence-based medical therapy for heart failure with reduced ejection fraction (HFrEF) often entails substantial out-of-pocket costs that can vary appreciably between patients. This has raised concerns regarding financial toxicity, equity, and adherence to medical therapy. In spite of these concerns, cost discussions in the HFrEF population appear to be rare, partly because out-of-pocket costs are generally unavailable during clinical encounters. In this trial, out-of-pocket cost information is given to patients and clinicians during outpatient encounters with the aim to assess the impact of providing this information on medication discussions and decisions. HYPOTHESIS: Cost-informed decision-making will be facilitated by providing access to patient-specific out-of-pocket cost estimates at the time of clinical encounter. DESIGN: Integrating Cost into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction (POCKET-COST-HF) is a multicenter trial based at Emory Healthcare and University of Colorado Health. Adapting an existing patient activation tool from the EPIC-HF trial, patients and clinicians are presented a checklist with medications approved for treatment of HFrEF with or without patient-specific out-of-pocket costs (obtained from a financial navigation firm). Clinical encounters are audio-recorded, and patients are surveyed about their experience. The trial utilizes a stepped-wedge cluster randomized design, allowing for each site to enroll control and intervention group patients while minimizing contamination of the control arm. DISCUSSION: This trial will elucidate the potential impact of robust cost disclosure efforts and key information regarding patient and clinician perspectives related to cost and cost communication. It also will reveal important challenges associated with providing out-of-pocket costs for medications during clinical encounters. Acquiring medication costs for this trial requires an involved process and outsourcing of work. In addition, costs may change throughout the year, raising questions regarding what specific information is most valuable. These data will represent an important step towards understanding the role of integrating cost discussions into heart failure care. GOV IDENTIFIER: NCT04793880.

Deciding Whether to Take Sacubitril/Valsartan: How Cardiologists and Patients Discuss Out-of-Pocket Costs.

Background Out-of-pocket costs have significant implications for patients with heart failure and should ideally be incorporated into shared decision-making for clinical care. High out-of-pocket cost is one potential reason for the slow uptake of newer guideline-directed medical therapies for heart failure with reduced ejection fraction. This study aims to characterize patient-cardiologist discussions involving out-of-pocket costs associated with sacubitril/valsartan during the early postapproval period. Methods and Results We conducted content analysis on 222 deidentified transcripts of audio-recorded outpatient encounters taking place between 2015 and 2018 in which cardiologists (n=16) and their patients discussed whether to initiate, continue, or discontinue sacubitril/valsartan. In the 222 included encounters, 100 (45%) contained discussions about cost. Cost was discussed in a variety of contexts: when sacubitril/valsartan was initiated, not initiated, continued, and discontinued. Of the 97 cost conversations analyzed, the majority involved isolated discussions about insurance coverage (64/97 encounters; 66%) and few addressed specific out-of-pocket costs or affordability (28/97 encounters; 29%). Discussion of free samples of sacubitril/valsartan was common (52/97 encounters; 54%), often with no discussion of a longer-term plan for addressing cost. Conclusions Although cost conversations were somewhat common in patient-cardiologist encounters in which sacubitril/valsartan was discussed, these conversations were generally superficial, rarely addressing affordability or cost-value judgments. Cardiologists frequently provided patients with a course of free sacubitril/valsartan samples without a plan to address the cost after the samples ran out.

Impact of Financial Considerations on Willingness to Take Sacubitril/Valsartan for Heart Failure.

Background Sacubitril/valsartan improves health outcomes for heart failure with reduced ejection fraction relative to angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, but it carries higher out-of-pocket costs. Neither the impact of cost nor how to integrate cost into medical decisions is well studied. Methods and Results To evaluate the impact of out-of-pocket costs and a novel cost-priming intervention on willingness to take sacubitril/valsartan for heart failure with reduced ejection fraction, participants with self-reported heart disease were surveyed using the online Ipsos Knowledge Panel. Participants were presented with a modified decision aid for sacubitril/valsartan and then, in a 3×2 factorial design, randomly assigned to 1 of 3 cost conditions ($10, $50, or $100/month) and to a control group or cost-priming intervention, defined by being asked questions about their financial situation before learning about the benefits of sacubitril/valsartan. Of the 1013 participants included in the analysis, 85% of respondents were willing to take sacubitril/valsartan at $10, 62% at $50, and 33% at $100 (P<0.0001). In a multivariable logistic regression model, participants were more likely to take sacubitril/valsartan at $10 versus $100 (odds ratio [OR], 14.3 [95% CI, 9.4-21.8]) and $50 compared with $100 (OR, 3.6 [95% CI, 2.5-5.1]). Overall, participants in the cost-primed group were more willing to take sacubitril/valsartan than those not primed to consider their financial situation (63% versus 56%, P=0.04). There was no statistically significant interaction between cost conditions and cost priming. Perceived benefit of sacubitril/valsartan over angiotensin-converting enzyme inhibitors or angiotensin receptor blockers decreased as cost increased but did not vary by cost priming. Conclusions Commonly encountered out-of-pocket costs of sacubitril/valsartan may impact individuals' willingness to take the medication even when recommended by their physicians. Priming individuals to consider personal finances before learning about the drug increased willingness to take sacubitril/valsartan.

The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop.

OBJECTIVES: Severe acute brain injury (SABI) from cardiac arrest and traumatic brain injury happens suddenly and unexpectedly, carrying high potential for lifelong disability with substantial prognostic uncertainty. Comprehensive assessments of family experiences and support needs after SABI are lacking. Our objective is to elicit "on-the-ground" perspectives about the experiences and needs of families of patients with SABI. DESIGN: Two-phase qualitative study of families and multidisciplinary U.S. healthcare professionals (mHCPs) with expertise in SABI: Phase 1 included semistructured interviews to generate formative findings; phase 2 entailed facilitated discussions to confirm and expand initial findings. SETTING: Phase 1: academic medical center; phase 2: virtual workshop. SUBJECTS: Phase 1 included seven family members and 12 mHCPs. Phase 2 included nationally recruited stakeholders (17 family members and 12 mHCPs). INTERVENTION: None. MEASUREMENTS AND RESULTS: We explored: 1) what are families' needs in the first 48 hours? 2) How are these needs addressed? and 3) How can hospitals better meet these needs? Qualitative analysis included inductive and deductive approaches guided by a conceptual ecological model. Four major needs were identified: 1) challenges in coping with uncertainty in early prognostication, 2) inattention to physical needs of family, 3) deficits in compassionate and consistent communication, and 4) need for engagement with families as stakeholders in improving future practices. Participants' recommendations included: 1) ways to communicate more clearly and consistently, 2) better assistance with navigating resources and access to places for families to care for themselves, and 3) opportunities for families to remain connected with their loved ones, social support networks, and the clinical team. CONCLUSIONS: Stakeholders identified novel insights regarding families' experiences during the hospitalization of comatose SABI patients and factors that can contribute to improved decision-making and physical/emotional outcomes. Interventions to address these unmet needs are promising targets to improve outcomes.

Experimenting with modifications to consent forms in comparative effectiveness research: understanding the impact of language about financial implications and key information.

BACKGROUND: Informed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown. METHODS: Two online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial. RESULTS: Likelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002). CONCLUSIONS: These findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment.

Show Me the Money: Patients' Perspectives on a Decision Aid for Sacubitril/Valsartan Addressing Out-of-Pocket Cost.

BACKGROUND: Out-of-pocket medication costs for patients who have heart failure with reduced ejection fraction may be an important part of shared decision-making, but cost has generally been excluded from clinical discussions. This study reports patients' perspectives on a decision aid for sacubitril/valsartan that explicitly addresses out-of-pocket costs. METHODS: Structured, in-depth interviews were conducted with 20 patients with heart failure with reduced ejection fraction from 2 medical centers to elicit their views on a publicly available decision aid for sacubitril/valsartan that explicitly incorporates considerations related to out-of-pocket costs. Qualitative descriptive analysis was conducted. RESULTS: Key themes identified were general enthusiasm for decision aids for medication decisions, openness on the part of patients to incorporation of cost into decision-making and the decision aid, requests for greater specificity regarding patient-specific cost, and challenges communicating evidence of benefit in a way that allows patients to make cost-benefit analyses for themselves. Patients also raised questions regarding logistical challenges of incorporating a decision aid into the normal clinical and decision-making workflow. CONCLUSIONS: Patients were receptive to the inclusion of out-of-pocket cost as relevant in a decision aid for sacubitril/valsartan. Key challenges to effective integration of cost in these decisions include developing mechanisms for acquiring reliable patient-specific cost estimates and addressing patients' difficulties (and sometimes skepticism) applying trial evidence to their own situation. In addition, implementation strategies are important to develop to facilitate decision aid integration for routine medical decisions into clinic workflow.

Heart Failure and Shared Decision-Making: Patients Open to Medication-Related Cost Discussions.

BACKGROUND: Discussions of medication costs between patients and clinicians are infrequent and often suboptimal. In the context of recently introduced drugs that are effective but expensive, patients with heart failure with reduced ejection fraction provide an ideal population to understand the perspectives of patients with chronic illness on medication cost and cost discussions. METHODS: To explore patients' perspectives on discussing out-of-pocket medication costs with clinicians, 49 adults, aged 44 to 70 years, with heart failure with reduced ejection fraction were recruited from outpatient heart failure clinics. Descriptive qualitative analysis was performed on open-ended text data. RESULTS: Participants who had prior medication-related cost discussions described their experience as generally positive, but about half of the participants had never had a cost discussion with their clinician. Most participants were open to cost discussions with clinicians and preferred that the clinician initiate discussions regarding medication cost. Importantly, these preferences held constant across reported levels of financial burden. CONCLUSIONS: These data suggest a substantial willingness on the part of patients with heart failure with reduced ejection fraction to incorporate cost discussions into their care and identify important aspects of these discussions for clinicians to consider when engaging in conversations where cost is relevant. Improving understanding about how to integrate patient preferences regarding cost discussions into clinical encounters is an important priority for advancing patient-centered care.

Discussing Out-of-Pocket Costs With Patients: Shared Decision Making for Sacubitril-Valsartan in Heart Failure.

Background "Financial toxicity" is a concern for patients, but little is known about how patients consider out-of-pocket cost in decisions. Sacubitril-valsartan provides a contemporary scenario to understand financial toxicity. It is guideline recommended for heart failure with reduced ejection fraction, yet out-of-pocket costs can be considerable. Methods and Results Structured interviews were conducted with 49 patients with heart failure with reduced ejection fraction at heart failure clinics and inpatient services. Patient opinions of the drug and its value were solicited after description of benefits using graphical displays. Descriptive quantitative analysis of closed-ended responses was conducted, and qualitative descriptive analysis of text data was performed. Of participants, 92% (45/49) said that they would definitely or probably switch to sacubitril-valsartan if their physician recommended it and out-of-pocket cost was $5 more per month than their current medication. Only 43% (21/49) would do so if out-of-pocket cost was $100 more per month ( P<0.001). At least 40% across all income categories would be unlikely to take sacubitril-valsartan at $100 more per month. Participants exhibited heterogeneous approaches to cost in decision making and varied on their use and interpretation of probabilistic information. Few (20%) participants stated physicians had initiated a conversation about cost in the past year. Conclusions Out-of-pocket cost variation reflective of contemporary cost sharing substantially influenced stated willingness to take sacubitril-valsartan, a guideline-recommended therapy with mortality benefit. These findings suggest a need for cost transparency to promote shared decision making. They also demonstrate the complexity of cost discussion and need to study how to incorporate out-of-pocket cost into clinical decisions.

Quality and Equitable Health Care Gaps for Women: Attributions to Sex Differences in Cardiovascular Medicine.

The present review synthesizes evidence and discusses issues related to health care quality and equity for women, including minority population subgroups. The principle of "sameness" or women and men receiving equitable, high-quality care is a near-term target, but optimal population health cannot be achieved without consideration of the unique, gendered structural determinants of health and the development of unique care pathways optimized for women. The aim of this review is to promote enhanced awareness, develop critical thinking in sex and gender science, and identify strategic pathways to improve the cardiovascular health of women. Delineation of the components of high-quality health care, including a women-specific research agenda, remains a vital part of strategic planning to improve the lives of women at risk for or living with cardiovascular disease.

Community consultation for prehospital research: experiences of study coordinators and principal investigators.

OBJECTIVE: To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. METHODS: Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. RESULTS: Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. CONCLUSIONS: Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.