Health Behavior Change Programs in Primary Care and Community Practices for Cardiovascular Disease Prevention and Risk Factor Management Among Midlife and Older Adults: A Scientific Statement From the American Heart Association.

Cardiovascular disease predominates as the leading health burden among middle-aged and older American adults, but progress in improving cardiovascular health remains slow. Comprehensive, evidenced-based behavioral counseling interventions in primary care are a recommended first-line approach for promoting healthy behaviors and preventing poor cardiovascular disease outcomes in adults with cardiovascular risk factors. Assisting patients to adopt and achieve their health promotion goals and arranging follow-up support are critical tenets of the 5A Model for behavior counseling in primary care. These 2 steps in behavior counseling are considered essential to effectively promote meaningful and lasting behavior change for primary cardiovascular disease prevention. However, adoption and implementation of behavioral counseling interventions in clinical settings can be challenging. The purpose of this scientific statement from the American Heart Association is to guide primary health care professional efforts to offer or refer patients for behavioral counseling, beyond what can be done during brief and infrequent office visits. This scientific statement presents evidence of effective behavioral intervention programs that are feasible for adoption in primary care settings for cardiovascular disease prevention and risk management in middle-aged and older adults. Furthermore, examples are provided of resources available to facilitate the widespread adoption and implementation of behavioral intervention programs in primary care or community-based settings and practical approaches to appropriately engage and refer patients to these programs. In addition, current national models that influence translation of evidence-based behavioral counseling in primary care and community settings are described. Finally, this scientific statement highlights opportunities to enhance the delivery of equitable and preventive care that prioritizes effective behavioral counseling of patients with varying levels of cardiovascular disease risk.

Number of Social Determinants of Health and Fatal and Nonfatal Incident Coronary Heart Disease in the REGARDS Study.

BACKGROUND: Social determinants of health (SDH) are individually associated with incident coronary heart disease (CHD) events. Indices reflecting social deprivation have been developed for population management, but are difficult to operationalize during clinical care. We examined whether a simple count of SDH is associated with fatal incident CHD and nonfatal myocardial infarction (MI). METHODS: We used data from the prospective longitudinal REGARDS cohort study (Reasons for Geographic and Racial Differences in Stroke), a national population-based sample of community-dwelling Black and White adults age ≥45 years recruited from 2003 to 2007. Seven SDH from the 5 Healthy People 2020 domains included social context (Black race, social isolation); education (educational attainment); economic stability (annual household income); neighborhood (living in a zip code with high poverty); and health care (lacking health insurance, living in 1 of the 9 US states with the least public health infrastructure). Outcomes were expert adjudicated fatal incident CHD and nonfatal MI. RESULTS: Of 22 152 participants free of CHD at baseline, 58.8% were women and 42.0% were Black; 20.6% had no SDH, 30.6% had 1, 23.0% had 2, and 25.8% had ≥3. There were 463 fatal incident CHD events and 932 nonfatal MIs over a median of 10.7 years (interquartile range, 6.6 to 12.7). Fewer SDHs were associated with nonfatal MI than with fatal incident CHD. The age-adjusted incidence per 1000 person-years increased with the number of SDH for both fatal incident CHD (0 SDH, 1.30; 1 SDH, 1.44; 2 SDH, 2.05; ≥3 SDH, 2.86) and nonfatal MI (0 SDH, 3.91; 1 SDH, 4.33; ≥2 SDH, 5.44). Compared with those without SDH, crude and fully adjusted hazard ratios for fatal incident CHD among those with ≥3 SDH were 3.00 (95% CI, 2.17 to 4.15) and 1.67 (95% CI, 1.18 to 2.37), respectively; hazard ratios for nonfatal MI among those with ≥2 SDH were 1.57 (95% CI, 1.30 to 1.90) and 1.14 (95% CI, 0.93 to 1.41), respectively. CONCLUSIONS: A greater burden of SDH was associated with a graded increase in risk of incident CHD, with greater magnitude and independent associations for fatal incident CHD. Counting the number of SDHs may be a promising approach that could be incorporated into clinical care to identify individuals at high risk of CHD.

Association of Perceived Stress With Incident Heart Failure.

BACKGROUND: The relationship between psychological stress and heart failure (HF) has not been well studied. We sought to assess the relationship between perceived stress and incident HF. METHODS: We used data from the national REasons for Geographic And Racial Differences in Stroke (REGARDS) study, a large prospective biracial cohort study that enrolled community-dwellers aged 45 years and older between 2003 and 2007, with follow-up. We included participants free of suspected prevalent HF who completed the Cohen 4-item Perceived Stress Scale (PSS-4). Our outcome variables were incident HF event, HF with reduced ejection fraction events, and HF with preserved ejection fraction events. We estimated Cox proportional hazard models to determine if PSS-4 quartiles were independently associated with incident HF events, adjusting for sociodemographics, social support, unhealthy behaviors, comorbid conditions, and physiologic parameters. We also tested interactions by baseline statin use, given its anti-inflammatory properties. RESULTS: Among 25,785 participants with a mean age of 64 ± 9.3 years, 55% were female and 40% were Black. Over a median follow-up of 10.1 years, 1109 ± 4.3% experienced an incident HF event. In fully adjusted models, the PSS-4 was not associated with HF or HF with reduced ejection fraction. However, PSS-4 quartiles 2-4 (compared with the lowest quartile) were associated with incident HF with preserved ejection fraction (Q2 hazard ratio 1.37, 95% confidence interval 1.00-1.88; Q3 hazard ratio 1.42, 95% confidence interval 1.03-1.95; Q4 hazard ratio 1.41, 95% confidence interval 1.04-1.92). Notably, this association was attenuated among participants who took a statin at baseline (P for interaction = .07). CONCLUSIONS: Elevated perceived stress was associated with incident HF with preserved ejection fraction but not HF with reduced ejection fraction.

Addressing Social Determinants of Health in the Care of Patients With Heart Failure: A Scientific Statement From the American Heart Association.

Heart failure is a clinical syndrome that affects >6.5 million Americans, with an estimated 550 000 new cases diagnosed each year. The complexity of heart failure management is compounded by the number of patients who experience adverse downstream effects of the social determinants of health (SDOH). These patients are less able to access care and more likely to experience poor heart failure outcomes over time. Many patients face additional challenges associated with the cost of complex, chronic illness management and must make difficult decisions about their own health, particularly when the costs of medications and healthcare appointments are at odds with basic food and housing needs. This scientific statement summarizes the SDOH and the current state of knowledge important to understanding their impact on patients with heart failure. Specifically, this document includes a definition of SDOH, provider competencies, and SDOH assessment tools and addresses the following questions: (1) What models or frameworks guide healthcare providers to address SDOH? (2) What are the SDOH affecting the delivery of care and the interventions addressing them that affect the care and outcomes of patients with heart failure? (3) What are the opportunities for healthcare providers to address the SDOH affecting the care of patients with heart failure? We also include a case study (Data Supplement) that highlights an interprofessional team effort to address and mitigate the effects of SDOH in an underserved patient with heart failure.

Bias and stereotyping among research and clinical professionals: Perspectives on minority recruitment for oncology clinical trials.

BACKGROUND: In recent years, extensive attention has been paid to the possibility that bias among health care professionals contributes to health disparities. In its 2003 report, the Institute of Medicine concluded that bias against racial minorities may affect communication or care offered. However, to the authors' knowledge, the role of bias within the context of recruitment of racial and ethnic minorities to cancer clinical trials has not been explored to date. Therefore, the authors assessed the experiences of clinical and research personnel related to factors influencing the recruitment of racial and ethnic minorities for cancer clinical trials. METHODS: A total of 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: 1) cancer center leaders; 2) principal investigators; 3) referring clinicians; and 4) research staff. Data analysis was conducted using a content analysis approach to generate themes from the transcribed interviews. RESULTS: Five prominent themes emerged: 1) recruitment interactions with potential minority participants were perceived to be challenging; 2) potential minority participants were not perceived to be ideal study candidates; 3) a combination of clinic-level barriers and negative perceptions of minority study participants led to providers withholding clinical trial opportunities from potential minority participants; 4) when clinical trial recruitment practices were tailored to minority patients, addressing research misconceptions to build trust was a common strategy; 5) for some respondents, race was perceived as irrelevant when screening and recruiting potential minority participants for clinical trials. CONCLUSIONS: Not only did some respondents view racial and ethnic minorities as less promising participants, some respondents reported withholding trial opportunities from minorities based on these perceptions. Some providers endorsed using tailored recruitment strategies whereas others eschewed race as a factor in trial recruitment. The presence of bias and stereotyping among clinical and research professionals recruiting for cancer clinical trials should be considered when designing interventions to increase minority enrollment.

Assembling and validating a heart failure-free cohort from the Reasons for Geographic and Racial Differences in Stroke (REGARDS) study.

BACKGROUND: Studies examining incident heart failure (HF) have been limited to select populations. To examine incident HF with broader generalizability, there is need to assemble a HF-free cohort using a geographically-diverse sample. We aimed to develop and validate a simple medication-based strategy for assembling a HF-free cohort from the REasons for Geographic And Racial Differences in Stroke (REGARDS) study. METHODS: We examined REGARDS participants with ≥6 months of Medicare inpatient and outpatient claims data at the time of the baseline in-home study examination. To assemble a HF-free cohort, we identified and excluded participants taking HF-specific medications. To validate this approach, we evaluated event rates among this cohort and assessed diagnostic performance using Medicare claims-based definitions of HF as the referent standard. RESULTS: Among 28,884 eligible participants, 3125 were excluded from the proposed HF-free cohort, leaving a total of 25,759 (89%) participants. Depending on the Medicare definition used as the referent, the negative predictive value of this approach ranged from 95.0-99.2%. Negative predictive value was stable across age, sex, and race strata. CONCLUSIONS: The approach to assemble a HF-free cohort in REGARDS can serve as the basis for future studies to examine incident HF in REGARDS and similar studies.

Low Utilization of Beta-Blockers Among Medicare Beneficiaries Hospitalized for Heart Failure With Reduced Ejection Fraction.

BACKGROUND: The evidence-based beta-blockers carvedilol, bisoprolol, and metoprolol succinate reduce mortality and hospitalizations among patients with heart failure with reduced ejection fraction (HFrEF). Use of these medications is not well described in the general population of patients with HFrEF, especially among patients with potential contraindications. OBJECTIVES: Our goal was to describe the patterns of prescription fills for carvedilol, bisoprolol, and metoprolol succinate among Medicare beneficiaries hospitalized for HFrEF, as well as to estimate the associations between specific contraindications for beta-blocker therapy and those patterns. METHODS AND RESULTS: With the use of the cohort of 15,205 Medicare beneficiaries hospitalized for HFrEF from 2007 to 2013 in the 5% Medicare random sample, we described prescription fills (30 days after discharge) and dosage patterns (1 year after discharge) for beta-blockers. By means of of Fine and Gray competing risk models, we estimated the associations between potential contraindications (hypotension, chronic obstructive pulmonary disease [COPD], asthma, and syncope) and prescription fill and dosing patterns while adjusting for demographics, comorbidities, and health care utilization. For beneficiaries who did not die or readmitted to the hospital, 38% of hospitalizations were followed by a prescription fill for an evidence-based beta-blocker within 30 days, 12% were followed by prescription fills for at least 50% of the recommended dose of an evidence-based beta-blocker within 1 year, and 9% were followed by a prescription fill for an up-titrated dose of an evidence-based beta-blocker within 1 year. The prevalence of the contraindications were 21% for hypotension, 48% for COPD, 15% for asthma, and 12% for syncope. Among beneficiaries who did not fill a prescription for an evidence-based beta-blocker within 30 days, 67% had at least 1 of these contraindications. Hypotension, COPD, and syncope were each associated with a ∼10% lower risk of filling a prescription for an evidence-based beta-blocker. CONCLUSIONS: Prescription fill and up-titration rates for evidence-based beta-blockers are low among Medicare beneficiaries with HFrEF, but contraindications explain only a minor part of these low rates.

Training Needs of Clinical and Research Professionals to Optimize Minority Recruitment and Retention in Cancer Clinical Trials.

The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority patient populations. However, clinical trial recruitment is complex and requires a broader appreciation of the multiple factors that influence minority participation. One area that has received little attention is minority recruitment training for professionals who assume various roles in the clinical trial recruitment process. Therefore, we assessed the perspectives of cancer center clinical and research personnel on their training and education needs toward minority recruitment for cancer clinical trials. Ninety-one qualitative interviews were conducted at five U.S. cancer centers among four stakeholder groups: cancer center leaders, principal investigators, referring clinicians, and research staff. Interviews were recorded and transcribed. Qualitative analyses focused on response data related to training for minority recruitment for cancer clinical trials. Four prominent themes were identified: (1) Research personnel are not currently being trained to focus on recruitment and retention of minority populations; (2) Training for minority recruitment and retention provides for a specific focus on factors influencing minority research participation; (3) Training on cultural awareness may help to bridge cultural gaps between potential minority participants and research professionals; (4) Views differ regarding the importance of research personnel training designed to focus on recruitment of minority populations. There is a lack of systematic training for minority recruitment. Many stakeholders acknowledged the benefits of minority recruitment training and welcomed training that focuses on increasing cultural awareness to increase the participation of minorities in cancer clinical trials.

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.

Medical therapy following hospitalization for heart failure with reduced ejection fraction and association with discharge to long-term care: a cross-sectional analysis of the REasons for Geographic And Racial Differences in Stroke (REGARDS) population.

BACKGROUND: Less intensive treatment for heart failure with reduced ejection fraction (HFrEF) may be appropriate for patients in long-term care settings because of limited life expectancy, frailty, comorbidities, and emphasis on quality of life. METHODS: We compared treatment patterns between REasons for Geographic And Racial Differences in Stroke (REGARDS) study participants discharged to long-term care versus home following HFrEF hospitalizations. We examined medical records and Medicare pharmacy claims for 147 HFrEF hospitalizations among 80 participants to obtain information about discharge disposition and medication prescriptions and fills. RESULTS: Discharge to long-term care followed 22 of 147 HFrEF hospitalizations (15%). Participants discharged to long-term care were more likely to be prescribed beta-blockers and less likely to be prescribed aldosterone receptor antagonists and hydralazine/isosorbide dinitrate (96%, 14%, and 5%, respectively) compared to participants discharged home (81%, 22%, and 23%, respectively). The percentages of participants discharged to long-term care and home who had claims for filled prescriptions were similar for beta-blockers (68% versus 66%) and angiotensin converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARBs) (45% versus 47%) after 1 year. Smaller percentages of participants discharged to long-term care had claims for filled prescriptions of other medications compared to participants discharged home (diuretics: long-term care-50%, home-72%; hydralazine/isosorbide dinitrate: long-term care-5%, home-23%; aldosterone receptor antagonists: long-term care-5%, home-23%). CONCLUSIONS: Differences in medication prescriptions and fills among individuals with HFrEF discharged to long-term care versus home may reflect prioritization of some medical therapies over others for patients in long-term care.

Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

BACKGROUND: Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). METHODS: We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. RESULTS: We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. CONCLUSIONS: Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. TRIAL REGISTRATION: Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

Southern Dietary Pattern is Associated With Hazard of Acute Coronary Heart Disease in the Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study.

BACKGROUND: The association of overall diet, as characterized by dietary patterns, with risk of incident acute coronary heart disease (CHD) has not been studied extensively in samples including sociodemographic and regional diversity. METHODS AND RESULTS: We used data from 17 418 participants in Reasons for Geographic and Racial Differences in Stroke (REGARDS), a national, population-based, longitudinal study of white and black adults aged ≥45 years, enrolled from 2003 to 2007. We derived dietary patterns with factor analysis and used Cox proportional hazards regression to examine hazard of incident acute CHD events - nonfatal myocardial infarction and acute CHD death - associated with quartiles of consumption of each pattern, adjusted for various levels of covariates. Five primary dietary patterns emerged: Convenience, Plant-based, Sweets, Southern, and Alcohol and Salad. A total of 536 acute CHD events occurred over a median (interquartile range) 5.8 (2.1) years of follow-up. After adjustment for sociodemographics, lifestyle factors, and energy intake, highest consumers of the Southern pattern (characterized by added fats, fried food, eggs, organ and processed meats, and sugar-sweetened beverages) experienced a 56% higher hazard of acute CHD (comparing quartile 4 with quartile 1: hazard ratio, 1.56; 95% confidence interval, 1.17-2.08; P for trend across quartiles=0.003). Adding anthropometric and medical history variables to the model attenuated the association somewhat (hazard ratio, 1.37; 95% confidence interval, 1.01-1.85; P=0.036). CONCLUSIONS: A dietary pattern characteristic of the southern United States was associated with greater hazard of CHD in this sample of white and black adults in diverse regions of the United States.

Diabetes, diabetes severity, and coronary heart disease risk equivalence: REasons for Geographic and Racial Differences in Stroke (REGARDS).

BACKGROUND: Evidence is mixed regarding whether diabetes confers equivalent risk of coronary heart disease (CHD) as prevalent CHD. We investigated whether diabetes and severe diabetes are CHD risk equivalents. METHODS: At baseline, participants in the REasons for Geographic and Racial Differences in Stroke (REGARDS) study (black and white US adults ≥45 years old recruited in 2003-2007) were categorized as having prevalent CHD only (self-reported or electrocardiogram evidence; n = 3,043), diabetes only (self-reported or elevated glucose; n = 4,012), diabetes and prevalent CHD (n = 1,529), and neither diabetes nor prevalent CHD (n = 17,155). Participants with diabetes using insulin and/or with albuminuria (urinary albumin-to-creatinine ratio ≥30 mg/g) were categorized as having severe diabetes. Participants were followed up through 2011 for CHD events (myocardial infarction or fatal CHD). RESULTS: During a mean follow-up of 5 years, 1,385 CHD events occurred. The hazard ratios of CHD events comparing participants with diabetes only, diabetes, and prevalent CHD and neither diabetes nor prevalent CHD with those with prevalent CHD were 0.65 (95% CI 0.54-0.77), 1.54 (95% CI 1.30-1.83), and 0.41 (95% CI 0.35-0.47), respectively, after adjustment for demographics and risk factors. Compared with participants with prevalent CHD, the hazard ratio of CHD events for participants with severe diabetes was 0.88 (95% CI 0.72-1.09). CONCLUSIONS: Participants with diabetes had lower risk of CHD events than did those with prevalent CHD. However, participants with severe diabetes had similar risk to those with prevalent CHD. Diabetes severity may need consideration when deciding whether diabetes is a CHD risk equivalent.

The impact of the combination of income and education on the incidence of coronary heart disease in the prospective Reasons for Geographic and Racial Differences in Stroke (REGARDS) cohort study.

BACKGROUND: We investigated the association between income-education groups and incident coronary heart disease (CHD) in a national prospective cohort study. METHODS: The REasons for Geographic And Racial Differences in Stroke study recruited 30,239 black and white community-dwelling adults between 2003 and 2007 and collected participant-reported and in-home physiologic variables at baseline, with expert adjudicated CHD endpoints during follow-up. Mutually exclusive income-education groups were: low income (annual household income <$35,000)/low education (< high school), low income/high education, high income/low education, and high income/high education. Cox models estimated hazard ratios (HR) for incident CHD for each exposure group, examining differences by age group. RESULTS: At baseline, 24,461 participants free of CHD experienced 809 incident CHD events through December 31, 2011 (median follow-up 6.0 years; interquartile range 4.5-7.3 years). Those with low income/low education had the highest incidence of CHD (10.1 [95% CI 8.4-12.1]/1000 person-years). After full adjustment, those with low income/low education had higher risk of incident CHD (HR 1.42 [95% CI: 1.14-1.76]) than those with high income/high education, but findings varied by age. Among those aged <65 years, compared with those reporting high income/high education, risk of incident CHD was significantly higher for those reporting low income/low education and low income/high education (adjusted HR 2.07 [95% CI 1.42-3.01] and 1.69 [95% CI 1.30-2.20], respectively). Those aged ≥ 65 years, risk of incident CHD was similar across income-education groups after full adjustment. CONCLUSION: For younger individuals, low income, regardless of education, was associated with higher risk of CHD, but not observed for ≥ 65 years. Findings suggest that for younger participants, education attainment may not overcome the disadvantage conferred by low income in terms of CHD risk, whereas among those ≥ 65 years, the independent effects of income and education are less pronounced.

Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

BACKGROUND: The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. METHODS: In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. RESULTS: The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. CONCLUSIONS: Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials.

State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual.

BACKGROUND: Patient navigation programs are emerging that aim to address disparities in clinical trial participation among medically underserved populations, including racial/ethnic minorities. However, there is a lack of consensus on the role of patient navigators within the clinical trial process as well as outcome measures to evaluate program effectiveness. METHODS: A review of the literature was conducted of PubMed, Medline, CINHAL, and other sources to identify qualitative and quantitative studies on patient navigation in clinical trials. The search yielded 212 studies, of which only 12 were eligible for this review. RESULTS: The eligible studies reported on the development of programs for patient navigation in cancer clinical trials, including training and implementation among African Americans, American Indians, and Native Hawaiians. A low rate of clinical trial refusal (range, 4%-6%) was reported among patients enrolled in patient navigation programs. However, few studies reported on the efficacy of patient navigation in increasing clinical treatment trial enrollment. CONCLUSIONS: Outcome measures are proposed to assist in developing and evaluating the efficacy and/or effectiveness of patient navigation programs that aim to increase participation in cancer clinical trials. Future research is needed to evaluate the efficacy of patient navigators in addressing barriers to clinical trial participation and increasing enrollment among medically underserved cancer patients.

Towards a shared understanding of the learning health system in a large academic-based health system: A qualitative analysis.

Healthcare delivery is currently undergoing major structural reform, and the Learning Health System (LHS) has been proposed as an aspirational model to guide healthcare transformation. As efforts to build LHS take considerable investment from health systems, it is critical to understand their leaders' perspectives on the rationale for pursuing an LHS and the potential benefits for doing so. This paper describes the qualitative analysis of semi-structured interviews (n = 17) with health system leaders about their general perceptions of the LHS, description of key attributes and potential benefits, and perception of barriers to and facilitators for advancing the model. Participants universally endorsed the goal of the local health system aspiring to become an LHS. Participants identified many recognized attributes of LHS, though they emphasized unique attributes and potential benefits. There was also heterogeneity in participants' views on what to prioritize, how to structure the local LHS within existing initiatives, and how new initiatives should be implemented. Improving conceptual clarity of attributes of the LHS would improve its potential in guiding future reform.

Social Determinants of Health and Cardiovascular Risk among Adults with Diabetes: The Reasons for Geographic and Racial Differences in Stroke (REGARDS) Study.

Background: Social determinants of health (SDOH) have been associated with diabetes risk; however, their association with cardiovascular disease (CVD) events in individuals with diabetes is poorly described. We hypothesized that a greater number of SDOH among individuals with diabetes would be associated with a higher risk of CVD events. Methods: The REasons for Geographic and Racial Differences in Stroke (REGARDS) study is a national, biracial cohort of 30,239 individuals ≥45 years old recruited in 2003-2007. We included 6,322 participants with diabetes at baseline, defined as healthcare professional diagnosis, diabetes medication use, or blood glucose values. Seven SDOH that were individually associated with CVD events were included (P<0.20). The outcome was CVD events, a composite of expert-adjudicated myocardial infarction, stroke, or cardiovascular death. We estimated Cox proportional hazard models to examine associations between number of SDOH (0, 1, 2, ≥3) and CVD events. Results: In an age and sex adjusted model, the presence of multiple SDOH significantly increased the risk of any CVD event (hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.26 to 1.74 for two SDOH; HR, 1.68; 95% CI, 1.43 to 1.96 for ≥3 SDOH). This finding was attenuated but remained statistically significant in a fully adjusted model (HR, 1.19; 95% CI, 1.01 to 1.40 for two SDOH; HR, 1.27; 95% CI, 1.07 to 1.50 for ≥3 SDOH). Conclusion: Having multiple SDOH was independently associated with an increased risk of CVD events, a finding driven by cardiovascular death. Identifying individuals with diabetes who have multiple SDOH may be helpful for detecting those at higher risk of experiencing or dying from CVD events.

Trajectory of Cognitive Decline After Incident Heart Failure Hospitalization: Findings From the REGARDS Study.

BACKGROUND: Cognitive impairment is common among adults with heart failure (HF) and associated with poor outcomes. However, less is known about the trajectory of cognitive decline after a first HF hospitalization. We examined the rate of cognitive decline among adults with incident HF hospitalization compared with those without HF hospitalization. METHODS AND RESULTS: The REGARDS (Reasons for Geographic and Racial Differences in Stroke) study is a prospective longitudinal study of 23 894 participants aged ≥45 years free of HF at baseline. HF hospitalization was expert adjudicated. Changes in global cognitive function (primary outcome) were assessed with the Six-Item Screener (range, 0-6). Secondary outcomes included change in Word List Learning (range, 0-30), Word List Delayed Recall (WLD; range, 0-10), and Animal Fluency Test (range, 0+). Segmented linear mixed-effects regression models were used. Over 5 years, mean scores across all 4 cognitive tests declined for all participants regardless of HF status. Those with incident HF hospitalization experienced faster declines in the Six-Item Screener versus those who were HF free (difference, -0.031 [95% CI, -0.047 to -0.016]; P<0.001), a finding that persisted in fully adjusted models. Those with incident HF hospitalization did not experience faster declines in Word List Learning, Word List Delayed Recall, or Animal Fluency Test scores compared with those without HF hospitalization. Participants with hospitalization for HF with preserved, compared with reduced, ejection fraction had faster decline in Animal Fluency Test. CONCLUSIONS: Global cognitive decline occurred faster among adults with incident HF hospitalization compared with those who remained free of HF hospitalization. This pattern was not seen for the other cognitive domains.