Patient-Centered Adult Cardiovascular Care: A Scientific Statement From the American Heart Association.

Patient-centered care is gaining widespread acceptance by the medical and lay communities and is increasingly recognized as a goal of high-quality health care delivery. Patient-centered care is based on ethical principles and aims at establishing a partnership between the health care team and patient, family member, or both in the care planning and decision-making process. Patient-centered care involves providing respectful care by tailoring management decisions to patients' beliefs, preferences, and values. A collaborative care approach can enhance patient engagement, foster shared decision-making that aligns with patient values and goals, promote more personalized and effective cardiovascular care, and potentially improve patient outcomes. The objective of this scientific statement is to inform health care professionals and stakeholders about the role and impact of patient-centered care in adult cardiovascular medicine. This scientific statement describes the background and rationale for patient-centered care in cardiovascular medicine, provides insight into patient-oriented medication management and patient-reported outcome measures, highlights opportunities and strategies to overcome challenges in patient-centered care, and outlines knowledge gaps and future directions.

Expanding revascularization trials to women and underserved minorities and shifting to patient-centered outcomes: RECHARGE trials program.

PURPOSE OF REVIEW: We review the limited available evidence informing coronary revascularization decisions in women and minorities, and introduce the RECHARGE trial program, which consists of two separate but integrated parallel multicenter, randomized trials comparing coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI), one exclusively enrolling women (RECHARGE:Women) and one exclusively enrolling Black or Hispanic patients (RECHARGE:Minorities). RECENT FINDINGS: The extensive evidence base supporting coronary revascularization suffers from under-representation of women, minorities and minoritized populations, and the use of heterogeneous primary composite outcomes whose components have varying strengths of association with prognosis and quality-of-life (QOL). In RECHARGE, participants will be followed for up to 10 years, with QOL assessments at baseline, 30 days, 3 months, every 6 months for 3 years, and annually thereafter. The primary endpoint is the hierarchical composite of time to all-cause mortality, time-averaged change from baseline in the physical component of the SF-12v2 physical summary score, and time-averaged change from baseline in the mental component of the SF12v2 summary score, evaluated using a win ratio. Independently adjudicated major adverse cardiovascular and noncardiovascular events and disease-specific QoL will be secondary endpoints. SUMMARY: The RECHARGE trials are the first revascularization trials to enroll exclusively women and minority patients and to use patient-centered outcomes as their primary outcome.

Improving diversity in cardiac surgery clinical trials with ROMA:Women as an exemplar.

PURPOSE OF REVIEW: To describe methods to improve representation of women in cardiac surgery clinical trials. RECENT FINDINGS: Cardiovascular disease risk among women is high. Historically, women have been excluded from cardiac surgery trials, in part due to restrictive inclusion criteria. Surgical outcomes, specifically after coronary artery bypass grafting, are consistently worse among female patients, and these outcomes have not improved over the last decade. Addressing treatment effects and clinical benefit among women requires accurate representation in cardiovascular surgery trials. ROMA:Women, is the first cardiac surgery trial to focus solely on women, with the goal of addressing underrepresentation. Through utilizing specific strategies, ROMA:Women is a promising first step in advancing health equity. SUMMARY: Strategies to ensure effective recruitment and representation among women in cardiac surgery clinical trials, such as tailored eligibility criteria and comprehensive strategies to improve communication and increase trust, are two of many potential approaches to address the structural barriers to female representation in cardiac surgery clinical trials. To date, ROMA:Women is an example of a trial that has shown extraordinary preliminary success enrolling women. Designing trials exclusively for women is one strategy to improve the diversity of clinical trial participation.

Understanding Symptom Self-Monitoring Needs Among Postpartum Black Patients: Qualitative Interview Study.

BACKGROUND: Pregnancy-related death is on the rise in the United States, and there are significant disparities in outcomes for Black patients. Most solutions that address pregnancy-related death are hospital based, which rely on patients recognizing symptoms and seeking care from a health system, an area where many Black patients have reported experiencing bias. There is a need for patient-centered solutions that support and encourage postpartum people to seek care for severe symptoms. OBJECTIVE: We aimed to determine the design needs for a mobile health (mHealth) patient-reported outcomes and decision-support system to assist Black patients in assessing when to seek medical care for severe postpartum symptoms. These findings may also support different perinatal populations and minoritized groups in other clinical settings. METHODS: We conducted semistructured interviews with 36 participants-15 (42%) obstetric health professionals, 10 (28%) mental health professionals, and 11 (31%) postpartum Black patients. The interview questions included the following: current practices for symptom monitoring, barriers to and facilitators of effective monitoring, and design requirements for an mHealth system that supports monitoring for severe symptoms. Interviews were audio recorded and transcribed. We analyzed transcripts using directed content analysis and the constant comparative process. We adopted a thematic analysis approach, eliciting themes deductively using conceptual frameworks from health behavior and human information processing, while also allowing new themes to inductively arise from the data. Our team involved multiple coders to promote reliability through a consensus process. RESULTS: Our findings revealed considerations related to relevant symptom inputs for postpartum support, the drivers that may affect symptom processing, and the design needs for symptom self-monitoring and patient decision-support interventions. First, participants viewed both somatic and psychological symptom inputs as important to capture. Second, self-perception; previous experience; sociocultural, financial, environmental, and health systems-level factors were all perceived to impact how patients processed, made decisions about, and acted upon their symptoms. Third, participants provided recommendations for system design that involved allowing for user control and freedom. They also stressed the importance of careful wording of decision-support messages, such that messages that recommend them to seek care convey urgency but do not provoke anxiety. Alternatively, messages that recommend they may not need care should make the patient feel heard and reassured. CONCLUSIONS: Future solutions for postpartum symptom monitoring should include both somatic and psychological symptoms, which may require combining existing measures to elicit symptoms in a nuanced manner. Solutions should allow for varied, safe interactions to suit individual needs. While mHealth or other apps may not be able to address all the social or financial needs of a person, they may at least provide information, so that patients can easily access other supportive resources.

State of the Science: The Relevance of Symptoms in Cardiovascular Disease and Research: A Scientific Statement From the American Heart Association.

Symptoms of cardiovascular disease drive health care use and are a major contributor to quality of life. Symptoms are of fundamental significance not only to the diagnosis of cardiovascular disease and appraisal of response to medical therapy but also directly to patients' daily lives. The primary purpose of this scientific statement is to present the state of the science and relevance of symptoms associated with cardiovascular disease. Symptoms as patient-reported outcomes are reviewed in terms of the genesis, manifestation, and similarities or differences between diagnoses. Specifically, symptoms associated with acute coronary syndrome, heart failure, valvular disorders, stroke, rhythm disorders, and peripheral vascular disease are reviewed. Secondary aims include (1) describing symptom measurement methods in research and application in clinical practice and (2) describing the importance of cardiovascular disease symptoms in terms of clinical events and other patient-reported outcomes as applicable.

Methodological Standards for the Design, Implementation, and Analysis of Randomized Trials in Cardiac Surgery: A Scientific Statement From the American Heart Association.

Cardiac surgery presents specific methodological challenges in the design, implementation, and analysis of randomized controlled trials. The purposes of this scientific statement are to review key standards in cardiac surgery randomized trial design and implementation, and to provide recommendations for conducting and interpreting cardiac surgery trials. Recommendations include a careful evaluation of the suitability of the research question for a clinical trial, assessment of clinical equipoise, feasibility of enrolling a representative patient cohort, impact of practice variations on the safety and efficacy of the study intervention, likelihood and impact of crossover, and duration of follow-up. Trial interventions and study end points should be predefined, and appropriate strategies must be used to ensure adequate deliverability of the trial interventions. Every effort must be made to ensure a high completeness of follow-up; trial design and analytic techniques must be tailored to the specific research question and trial setting.

Using Patient Decision Aids for Cardiology Care in Diverse Populations.

PURPOSE OF REVIEW: Patient decision aids (PDAs) are tools that help guide treatment decisions and support shared decision-making when there is equipoise between treatment options. This review focuses on decision aids that are available to support cardiac treatment options for underrepresented groups. RECENT FINDINGS: PDAs have been developed to support multiple treatment decisions in cardiology related to coronary artery disease, valvular heart disease, cardiac arrhythmias, heart failure, and cholesterol management. By considering the unique needs and preferences of diverse populations, PDAs can enhance patient engagement and promote equitable healthcare delivery in cardiology. In this review, we examine the benefits, challenges, and current trends in implementing PDAs, with a focus on improving decision-making processes and outcomes for patients from underrepresented racial and ethnic groups. In addition, the article highlights key considerations when implementing PDAs and potential future directions in the field.

Eliciting the educational needs and priorities of home care workers on end-of-life care for patients with heart failure using nominal group technique.

BACKGROUND: Home care workers, as paid caregivers, assist with many aspects of home-based heart failure care. However, most home care workers do not receive systematic training on end-of-life care for heart failure patients. AIM: To elicit the educational needs and priorities of home care workers caring for community- dwelling adults with heart failure at the end-of-life. DESIGN: Nominal group technique involving a semi-quantitative structured group process and point rating system was used to designate the importance of priorities elicited from home care workers. Individual responses to the question, "If you have ever cared for a heart failure patient who was dying (or receiving end-of-life care on hospice), what are some of the challenges you faced?", were aggregated into categories using directed content analysis methods. SETTING/PARTICIPANTS: Forty-one home care workers were recruited from a non-profit training and education organization in New York City. RESULTS: Individual responses to the question were aggregated into five categories: (1) how to cope and grieve; (2) assisting patients with behavior changes, (3) supporting patients to improve their quality of life, (4) assisting patients with physical symptom management, and (5) symptom recognition and assessment. CONCLUSIONS: Our findings confirm the need for the formal development and evaluation of an educational program for home care workers to improve the care of heart failure patients at the end-of-life. There is also a need for research on integrating home care workers into the interprofessional healthcare team to support optimal health outcomes for patients with heart failure.

A Review of Mortality Risk Prediction Models in Smartphone Applications.

Healthcare professionals in healthcare systems need access to freely available, real-time, evidence-based mortality risk prediction smartphone applications to facilitate resource allocation. The objective of this study is to evaluate the quality of smartphone mobile health applications that include mortality prediction models, and corresponding information quality. We conducted a systematic review of commercially available smartphone applications in Google Play for Android, and iTunes for iOS smartphone applications. We performed initial screening, data extraction, and rated smartphone application quality using the Mobile Application Rating Scale: user version (uMARS). The information quality of smartphone applications was evaluated using two patient vignettes, representing low and high risk of mortality, based on critical care data from the Medical Information Mart for Intensive Care (MIMIC) III database. Out of 3051 evaluated smartphone applications, 33 met our final inclusion criteria. We identified 21 discrete mortality risk prediction models in smartphone applications. The most common mortality predicting models were Sequential Organ Failure Assessment (SOFA) (n = 15) and Acute Physiology and Clinical Health Assessment II (n = 13). The smartphone applications with the highest quality uMARS scores were Observation-NEWS 2 (4.64) for iOS smartphones, and MDCalc Medical Calculator (4.75) for Android smartphones. All SOFA-based smartphone applications provided consistent information quality with the original SOFA model for both the low and high-risk patient vignettes. We identified freely available, high-quality mortality risk prediction smartphone applications that can be used by healthcare professionals to make evidence-based decisions in critical care environments.

Building trust and facilitating goals of care conversations: A qualitative study in people with heart failure receiving home hospice care.

BACKGROUND: Despite a majority of persons receiving hospice care in their homes, there are gaps in understanding how to facilitate goals of care conversations between persons with heart failure and healthcare providers. AIM: To identify barriers and facilitators which shape goals of care conversations for persons with heart failure in the context of home hospice. DESIGN: A qualitative descriptive study design was used with semi-structured interviews. SETTING/PARTICIPANTS: We conducted qualitative interviews with persons with heart failure, family caregivers, and interprofessional healthcare team members at a large not-for-profit hospice agency in New York City between March 2018 and February 2019. RESULTS: A total of 39 qualitative interviews were conducted, including with healthcare team members (e.g. nurses, physicians, social workers, spiritual counselors), persons with heart failure, and family caregivers. Three themes emerged from the qualitative interviews regarding facilitators and barriers in goals of care conversations for better decision-making: (1) trust is key to building and maintaining goals of care conversations; (2) lack of understanding and acceptance of hospice inhibits goals of care conversations; and (3) family support and engagement promote goals of care conversations. CONCLUSION: Findings from this study suggest that interventions designed to improve goals of care conversations in the home hospice setting should focus on promoting understanding and acceptance of hospice, family support and engagement, and building trusting relationships with interprofessional healthcare teams.

Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study.

BACKGROUND: Atrial fibrillation (AF) is associated with high recurrence rates and poor health-related quality of life (HRQOL) but few effective interventions to improve HRQOL exist. OBJECTIVE: The aim of this study was to examine the impact of the "iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology" (iHEART) intervention on HRQOL in patients with AF. METHODS: We randomized English- and Spanish-speaking adult patients with AF to receive either the iHEART intervention or usual care for 6 months. The iHEART intervention used smartphone-based electrocardiogram monitoring and motivational text messages. Three instruments were used to measure HRQOL: the Atrial Fibrillation Effect on Quality of Life (AFEQT), the 36-item Short-Form Health survey, and the EuroQol-5D. We used linear mixed models to compare the effect of the iHEART intervention on HRQOL, quality-adjusted life-years, and AF symptom severity. RESULTS: A total of 238 participants were randomized to the iHEART intervention (n = 115) or usual care (n = 123). Of the participants, 77% were men and 76% were white. More than half (55%) had an AF recurrence. Both arms had improved scores from baseline to follow-up for AFEQT and AF symptom severity scores. The global AFEQT score improved 18.5 and 11.2 points in the intervention and control arms, respectively (P < .05). There were no statistically significant differences in HRQOL, quality-adjusted life-years, or AF symptom severity between groups. CONCLUSIONS: We found clinically meaningful improvements in AF-specific HRQOL and AF symptom severity for both groups. Additional research with longer follow-up should examine the influence of smartphone-based interventions for AF management on HRQOL and address the unique needs of patients diagnosed with different subtypes of AF.

Brief Report: Patient Activation Among Urban Hospitalized Patients With Heart Failure.

BACKGROUND: Patient activation influences patients' ability to meaningfully engage in critical heart failure self-care. The purpose of this study was to identify whether patient activation is associated with patient-reported health outcomes in an urban and racially diverse inpatient sample of patients with heart failure. METHODS: We prospectively recruited patients with heart failure hospitalized at an urban academic medical center from October 2016 to May 2017 and measured patient activation, physical and affective symptoms, physical function, self-care, perceived control, and self-efficacy. Differences in patient-reported health outcomes between low and high activation groups were compared with the use of linear regression models adjusting for age, sex, education, left ventricular ejection fraction, and New York Heart Association functional classification. RESULTS: A total of 96 patients completed the study (mean age 57 ± 12.4 y); 39% identified as black and 35% as Latino, 35% were female, and 50% reported not having enough income to make ends meet. Based on the 4 levels of activation defined by the Patient Activation Measure-13, 22% of patients reported being "disengaged and overwhelmed," 14% were "becoming aware, but still struggling," 39% were "taking action," and 26% were "maintaining behaviors and pushing further." Higher patient activation was associated with better applied cognitive abilities, self-care behaviors, perceived control, and self-efficacy. CONCLUSION: Patient activation can be easily measured in hospitalized patients with heart failure and is associated with clinically meaningful patient-reported health outcomes.

Identifying distinct risk profiles to predict adverse events among community-dwelling older adults.

Preventing adverse events among chronically ill older adults living in the community is a national health priority. The purpose of this study was to generate distinct risk profiles and compare these profiles in time to: hospitalization, emergency department (ED) visit or death in 371 community-dwelling older adults enrolled in a Medicare demonstration project. Guided by the Behavioral Model of Health Service Use, a secondary analysis was conducted using Latent Class Analysis to generate the risk profiles with Kaplan Meier methodology and log rank statistics to compare risk profiles. The Vuong-Lo-Mendell-Rubin Likelihood Ratio Test demonstrated optimal fit for three risk profiles (High, Medium, and Low Risk). The High Risk profile had significantly shorter time to hospitalization, ED visit, and death (p < 0.001 for each). These findings provide a road map for generating risk profiles that could enable more effective targeting of interventions and be instrumental in reducing health care costs for subgroups of chronically ill community-dwelling older adults.

A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol.

BACKGROUND: Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia, affecting an estimated 2.7 million Americans. The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic; therefore, it is challenging to detect and record an occurrence in a "real world" setting. To date, mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated. This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality-adjusted life years. Furthermore, sending a daily electrocardiogram transmission, coupled with receiving educational and motivational text messages aimed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions (e.g., hypertension, diabetes, heart failure, etc.). Therefore, we are currently conducting a randomized controlled trial to assess the efficacy of a mobile health intervention, iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) versus usual cardiac care. METHODS: The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with an AliveCor® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months. DISCUSSION: This will be the first study to investigate the utility of a mobile health intervention in a "real world" setting. We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention's impact on improving clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge. TRIAL REGISTRATION: NCT02731326 ; Verified April 2016.

Identifying biomarker patterns and predictors of inflammation and myocardial stress.

BACKGROUND: Regular exercise is recommended to improve outcomes in patients with heart failure. Exercise is known to decrease inflammation and thought to decrease myocardial stress; however, studies of exercise in heart failure have had mixed results on levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and high-sensitivity C-reactive protein (hsCRP). A multimarker analysis may help to identify distinct subgroups of patients who respond to exercise. Our primary study objective was to identify common and distinct patterns of change in hsCRP and NT-proBNP and to quantify the influence of exercise therapy on the observed patterns of change. METHODS AND RESULTS: NT-proBNP and hsCRP were assessed in a random sample of 320 participants from the biomarker substudy of HF-ACTION, a randomized clinical trial of exercise training versus usual care in patients with stable and chronic heart failure. Growth mixture modeling was used to identify unique biomarker patterns over 12 months. Three statistically independent and clinically meaningful biomarker patterns of NT-proBNP and hsCRP were identified. Two patterns were combined and compared with the "low/stable" pattern, which was characterized by the lowest levels of NT-proBNP and hsCRP over time. Participants who were taking a loop diuretic and had hypertension or ischemic etiology were ∼2 times as likely to be in the "elevated/worsening" biomarker pattern. Participants randomized to the exercise intervention were less likely to be in the elevated/worsening pattern of NT-proBNP and hsCRP (relative risk ratio 0.56, 95% confidence interval 0.32-0.98; P = .04). CONCLUSIONS: Exercise therapy was protective for reducing the frequency of membership in the elevated/worsening biomarker pattern, indicating that exercise may be helpful in delaying the progression of heart failure.

Comorbidity profiles and inpatient outcomes during hospitalization for heart failure: an analysis of the U.S. Nationwide inpatient sample.

BACKGROUND: Treatment of heart failure (HF) is particularly complex in the presence of comorbidities. We sought to identify and associate comorbidity profiles with inpatient outcomes during HF hospitalizations. METHODS: Latent mixture modeling was used to identify common profiles of comorbidities during adult hospitalizations for HF from the 2009 Nationwide Inpatient Sample (n = 192,327). RESULTS: Most discharges were characterized by "common" comorbidities. A "lifestyle" profile was characterized by a high prevalence of uncomplicated diabetes, hypertension, chronic pulmonary disorders and obesity. A "renal" profile had the highest prevalence of renal disease, complicated diabetes, and fluid and electrolyte imbalances. A "neurovascular" profile represented the highest prevalence of cerebrovascular disease, paralysis, myocardial infarction and peripheral vascular disease. Relative to the common profile, the lifestyle profile was associated with a 15% longer length of stay (LOS) and 12% greater cost, the renal profile was associated with a 30% higher risk of death, 27% longer LOS and 24% greater cost, and the neurovascular profile was associated with a 45% higher risk of death, 34% longer LOS and 37% greater cost (all p < 0.001). CONCLUSIONS: Comorbidity profiles are helpful in identifying adults at higher risk of death, longer length of stay, and accumulating greater costs during hospitalizations for HF.

Adapting heart failure guidelines for nursing care in home health settings: challenges and solutions.

BACKGROUND: Nurses provide most of home health services for patients with heart failure, and yet there are no evidence-based practice guidelines developed for home health nurses. PURPOSE: The purpose of this article was to review the challenges and solutions for adapting generally available HF clinical practice guidelines to home health nursing. METHODS: Appropriate HF guidelines were identified and home health nursing-relevant guidelines were extracted by the research team. In addition, a team of nursing academic and practice experts evaluated the extracted guidelines and reached consensus through Delphi rounds. RESULTS: We identified 172 recommendations relevant to home health nursing from the American Heart Association and Heart Failure Society of America guidelines. The recommendations were divided into 5 groups (generic, minority populations, normal ejection fraction, reduced ejection fraction, and comorbidities) and further subgroups. Experts agreed that 87% of the recommendations selected by the research team were relevant to home health nursing and rejected 6% of the selected recommendations. Experts' opinions were split on 7% of guideline recommendations. Experts mostly disagreed on recommendations related to HF medication and laboratory prescription as well as HF patient assessment. These disagreements were due to lack of patient information available to home health nurses as well as unclear understanding of scope of practice regulations for home health nursing. After 2 Delphi rounds over 8 months, we achieved 100% agreement on the recommendations. The finalized guideline included 153 recommendations. CONCLUSIONS: Guideline adaptation projects should include a broad scope of nursing practice recommendations from which home health agencies can customize relevant recommendations in accordance with available information and state and agency regulations.

Using brief motivational interviewing to address the complex needs of a challenging patient with heart failure.

BACKGROUND: Hospitals and healthcare providers are looking for methods to reduce hospitalization rates and improve patient outcomes for patients with heart failure (HF). Using behavioral approaches to increase patients' confidence in their abilities to perform self-care is 1 such approach. Motivational interviewing is an empirically validated modality that has shown promise in improving motivation to change and confidence in the ability to do so. OBJECTIVE: This case represents a number of themes common in the management of care for a HF patient and explores a 4-session brief motivational interviewing approach to address these themes. The manner in which patient frustration is linked to hospitalization is discussed along with possible ways to address problems in self-care behaviors. CONCLUSIONS: With the use of this brief motivational interviewing approach, the patient reported an increase in her motivation and ability to change and developed a postdischarge plan for incorporating self-care behaviors in her daily routine. CLINICAL IMPLICATIONS: Motivational interviewing may be an effective method of increasing the self-care behaviors of patients with HF.