Design of a bilevel clinical trial targeting adherence in heart failure patients and their providers: The Congestive Heart Failure Adherence Redesign Trial (CHART).

BACKGROUND: Socioeconomically disadvantaged patients are at an increased risk for adverse heart failure (HF) outcomes based upon nonadherence to medications and diet. Physicians are also suboptimally adherent to prescribing evidence-based therapy for HF. METHODS: Congestive Heart Failure Adherence Redesign Trial (CHART) (NCT01698242) is a multicenter, bilevel, cluster randomized behavioral efficacy trial designed to assess the impact of intervening simultaneously on physicians and their socioeconomically disadvantaged patients (annual income <$30,000) having HF with reduced ejection fraction. Treatment arm physicians received individualized feedback on their adherence to prescribing evidence-based therapy. Their patients received weekly home visits from community health workers aimed at promoting understanding of HF and integrating adherence into daily life. Control arm physicians received regular updates on advances in HF management, and patients received monthly HF educational tip sheets produced by the American Heart Association. The primary outcome was all-cause hospital days over 30 months. RESULTS: A total of 72 physicians (treatment, 35; control, 37) and their 320 patients (treatment, 157; control, 163) were recruited within 2 years. Randomization of physicians with all of their patients being assigned to the same arm was feasible and did not compromise the comparability of patients by arm. Using 5 recruiting hospitals located within disadvantaged neighborhoods produced a cohort that was primarily African American and representative of low-income urban patients with HF with reduced ejection fraction. CONCLUSION: CHART will determine the value of intervening on low adherence simultaneously in physicians and their socioeconomically disadvantaged patients in reducing all-cause hospitalization days.

Does self-management counseling in patients with heart failure improve quality of life? Findings from the Heart Failure Adherence and Retention Trial (HART).

PURPOSE: Heart failure (HF) is associated with poor health-related quality of life (HRQOL). The purpose of our study is to determine the effect of a self-management intervention on HRQOL domains across time, overall, and in prespecified demographic, clinical, and psychosocial subgroups of HF patients. METHODS: HART was a single-center, multi-hospital randomized trial. Patients (n = 902) were randomized either to a self-management intervention with provision of HF educational information or an enhanced education control group which received the same HF educational materials. HRQOL was measured by the Quality of Life Index, Cardiac Version, modified, and the Medical Outcomes Study 36-item Short-Form Health Survey physical functioning scale. Analyses included descriptive statistics and mixed-effects regression models. RESULTS: In general, overall, study participants' HRQOL improved over time. However, no significant differences in HRQOL domain were detected between treatment groups at baseline or across time (p > 0.05). Subgroup analyses demonstrated no differences by treatment arm for change in HRQOL from baseline to 3 years later. CONCLUSIONS: We conclude that in our cohort of patients, the self-management intervention had no benefit over enhanced education in improving domains of HRQOL and HRQOL for specified HF subgroups.

Applying the lessons of design thinking: a unique programme of care for acutely unwell, community-dwelling COVID-19 patients.

BACKGROUND: The COVID-19 pandemic limited access to primary care and in-person assessments requiring healthcare providers to re-envision care delivery for acutely unwell outpatients. Design thinking methodology has the potential to support the robust evolution of a new clinical model. AIM: To demonstrate how design thinking methodology can rapidly and rigorously create and evolve a safe, timely, equitable and patient-centred programme of care, and to share valuable lessons for effective implementation of design thinking solutions to address complex problems. METHOD: We describe how design thinking methodology was employed to create a new clinical model of care. Using the example of a novel telemedicine programme to support acutely unwell, community-dwelling COVID-19-positive patients called the London Urgent COVID-19 Care Clinic (LUC3), we show how continuous quality outcomes (safety, timeliness, equity and patient-centredness), as well as patient experience survey responses, can drive iterative changes in programme delivery. RESULTS: The inspiration phase identified four key needs for this patient population: monitoring COVID-19 signs and symptoms; self-managing COVID-19 symptoms; managing other comorbidities in the setting of COVID-19; and escalating care as needed. Guided by these needs, a cross-disciplinary stakeholder group was engaged in the ideation and implementation phases to create a unique and comprehensive telemedicine programme (LUC3). During the implementation phase, LUC3 assessed 2202 community-based patients diagnosed with acute COVID-19; the collected quality outcomes and end-user feedback led to evolution of programme delivery. CONCLUSION: Design thinking methodology provided an essential framework and valuable lessons for the development of a safe, equitable, timely and patient-centred telemedicine care programme. The lessons learnt here-the importance of inclusive collaboration, using empathy to guide equity-focused interventions, leveraging continuous metrics to drive iteration and aiming for good-if-not-perfect plans-can serve as a road map for using design thinking for targeted healthcare problems.

Depression predicts repeated heart failure hospitalizations.

OBJECTIVE: Management of depression, if it is independently associated with repeated hospitalizations for heart failure (HF), offers promise as a viable and cost-effective strategy to improve health outcomes and reduce health care costs for HF. The objective of this study was to assess the association between depression and the number of HF-related hospitalizations in patients with low-to-moderate systolic or diastolic dysfunction, after controlling for illness severity, socioeconomic factors, physician adherence to evidence-based medications, patient adherence to HF drug therapy, and patient adherence to salt restrictions. METHODS AND RESULTS: The Heart Failure Adherence and Retention Trial (HART) was a randomized behavioral trial to evaluate whether patient self-management skills coupled with HF education improved patient outcomes. Depression was measured at baseline with the Geriatric Depression Scale (GDS). The number of hospitalizations was analyzed with a negative binomial regression model that included an offset term to account for the differential duration of follow-up for individual subjects. The average unadjusted number of hospitalizations per year was 0.40 in the depressed group (GDS ≥10) and 0.33 in the nondepressed group (GDS <10). Depression was a strong predictor (incident rate ratio 1.45; P = .006) after adjusting for physician adherence to evidence-based medication use, patient adherence to HF drug therapy, patient adherence to salt restriction, illness severity, HF severity (6-minute walk <620 feet), and socioeconomic factors. CONCLUSIONS: Depression is a strong psychosocial predictor of repeated hospitalizations for HF. Compared with nondepressed individuals, those with depression were hospitalized for HF 1.45 times more often, even after controlling for physician adherence to evidence-based medications and patient adherence to HF drug therapy and salt restrictions. This finding suggests that clinicians should screen for depression early in the course of HF management.

Attenuation of the side effect profile of regadenoson: a randomized double-blinded placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging. "The ASSUAGE trial".

BACKGROUND: It is unknown whether the standardized intravenous aminophylline administration following regadenoson-stress can prevent the gastrointestinal and other adverse effects associated with regadenoson. METHODS: In a randomized, double-blinded, placebo-controlled clinical trial we compared the frequency and severity of regadenoson adverse effects in those who received 75 mg of intravenous aminophylline versus a matching placebo administered 2 minutes after regadenoson or 90 seconds post-radioisotope injection. RESULTS: 248 patients [44.8% women, mean age 62.2 (± 13.3) years] were randomized to receive aminophylline (124) or placebo (124). In the aminophylline arm, there was 50% reduction in the incidence of the primary endpoint of diarrhea and abdominal discomfort [11 (8.9%) vs 22 (17.7%), P = .04] and 70% reduction in the incidence of diarrhea [4 (3.2%) vs 13 (10.5%), P = .02]. Additionally, aminophylline use was associated with 34% reduction in the secondary endpoint of any regadenoson adverse effects [55 (44.4%) vs 83 (66.9%), P < .001] and 71% reduction in headache [9 (7.3%) vs 31 (25%), P < .001]. The stress protocol was better tolerated in the aminophylline group (P = .007). The quantitative summed difference score was similar in both study groups (P = .92). There were no excess adverse events in the aminophylline arm. CONCLUSIONS: This trial supports the routine administration of IV-aminophylline to reduce the frequency and severity of adverse effects associated with regadenoson-stress.

Self-management counseling in patients with heart failure: the heart failure adherence and retention randomized behavioral trial.

CONTEXT: Motivating patients with heart failure to adhere to medical advice has not translated into clinical benefit, but past trials have had methodological limitations. OBJECTIVE: To determine the value of self-management counseling plus heart failure education, compared with heart failure education alone, for the primary end point of death or heart failure hospitalization. DESIGN, SETTING, AND PATIENTS: The Heart Failure Adherence and Retention Trial (HART), a single-center, multiple-hospital, partially blinded behavioral efficacy randomized controlled trial involving 902 patients with mild to moderate heart failure and reduced or preserved systolic function, randomized from the Chicago metropolitan area between October 2001 and October 2004 and undergoing follow-up for 2 to 3 subsequent years. INTERVENTIONS: All patients were offered 18 contacts and 18 heart failure educational tip sheets during the course of 1 year. Patients randomized to the education group received tip sheets in the mail and telephone calls to check comprehension. Patients randomized to the self-management group received tip sheets in groups and were taught self-management skills to implement the advice. MAIN OUTCOME MEASURE: Death or heart failure hospitalization during a median of 2.56 years of follow-up. RESULTS: Patients were representative of typical clinical populations (mean age, 63.6 years; 47% women, 40% racial/ethnic minority, 52% with annual family income less than $30,000, and 23% with preserved systolic function). The rate of the primary end point in the self-management group was no different from that in the education group (163 [40.1%)] vs 171 [41.2%], respectively; odds ratio, 0.95 [95% confidence interval, 0.72-1.26]). There were no significant differences on any secondary end points, including death, heart failure hospitalization, all-cause hospitalization, or quality of life. CONCLUSIONS: Compared with an enhanced educational intervention alone, the addition of self-management counseling did not reduce death or heart failure hospitalization in patients with mild to moderate heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00018005.

Enhancing Physician Managerial Capabilities: Partnership between Medicine and Business.

This article was migrated. The article was marked as recommended. Background Physicians are typically appointed to leadership roles within health care organizations on the basis of individual accomplishments in research, education, and/or clinical care. However, these types of achievements seldom provide the requisite management capabilities to lead within health organizations. In this manuscript, we described our initial experience in developing an in-house program to provide current and aspiring physician leaders with the managerial capabilities to enhance the quality of health care delivery within their respective organization. Methods In a partnership established between a Medical School and a Business School, we designed two series of weekend workshops to provide current and aspiring physician leaders with the financial capabilities to assist them in their future healthcare leadership careers. This course was then expanded to a Management Principles for Physician workshop with open enrollment to physicians at all levels. Baseline demographics and participant evaluations of each course were recorded. In the open enrollment Management Principles for Physician workshop, we examined the relationship between participant background and their course evaluations as well as their areas of interest for further training. Results All 3 workshops received excellent evaluations by participants. The positive impact of the open enrollment program, based on participants' self-evaluations, was the highest in female physicians, as well as early to mid-career physicians. Additionally, physicians who do not currently hold leadership positions and those who are leading at Divisional levels were the most interested in further training in finance. Conclusion In summary, this series of workshops demonstrated the feasibility of an in-house physician leadership program and yielded important information for the design of future leadership development curriculum.

The Heart Failure Adherence and Retention Trial (HART): design and rationale.

BACKGROUND: Heart failure (HF) is increasing in prevalence and is associated with prolonged morbidity, repeat hospitalizations, and high costs. Drug therapies and lifestyle changes can reduce hospitalizations, but nonadherence is high, ranging from 30% to 80%. There is an urgent need to identify cost-effective ways to improve adherence and reduce hospitalizations. TRIAL DESIGN: The Heart Failure Adherence and Retention Trial (HART) evaluated the benefit of patient self-management (SM) skills training in combination with HF education, over HF education alone, on the composite end points of death/HF hospitalizations and death/all-cause hospitalizations in patients with mild to moderate systolic or diastolic dysfunction. Secondary end points included progression of HF, quality of life, adherence to drug and lifestyle regimens, and psychosocial function. The HART cohort was composed of 902 patients including 47% women, 40% minorities, and 23% with diastolic dysfunction. After a baseline examination, patients were randomized to SM or education control, received 18 treatment contacts over 1 year, annual follow-ups, and 3-month phone calls to assess primary end points. Self-management treatment was conducted in small groups and aimed to activate the patient to implement HF education through training in problem-solving and 5 SM skills. The education control received HF education in the mail followed by a phone call to check comprehension. CONCLUSIONS: The significance of HART lies in its ability to determine the clinical value of activating the patient to collaborate in his or her care. Support for the trial hypotheses would encourage interdisciplinary HF treatment, drawing on an evidence base not only from medicine but also from behavioral medicine.

Patterns of transfer for patients with non-ST-segment elevation acute coronary syndrome from community to tertiary care hospitals.

BACKGROUND: Practice guidelines for non-ST-segment elevation acute coronary syndromes (NSTE ACS) recommend early invasive management (cardiac catheterization and revascularization within 48 hours of hospital presentation) for high-risk patients, but interhospital transfer is necessary to provide rapid access to revascularization procedures for patients who present to community hospitals without revascularization capabilities. METHODS: We analyzed patterns and factors associated with interhospital transfer among 19,238 patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) from 124 community hospitals without revascularization capabilities in the Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines quality improvement initiative from January 2001 through June 2004. RESULTS: Less than half of the patients (46.3%) admitted to community hospitals were transferred to tertiary hospitals, and fewer (20%) were transferred early (within 48 hours of presentation). Early transfer rates increased by 16% over 10 quarters in patients with a predicted low or moderate risk of inhospital mortality, compared with 5% in high-risk patients. By the last quarter of the analysis, 41.4% of low-risk patients were transferred early versus 12.5% of high-risk patients. Factors significantly associated with early transfer included younger age, lack of prior heart failure, cardiology inpatient care, and ischemic ST-segment electrocardiographic changes. Among patients who were not transferred, 29% had no further risk stratification performed with stress testing, ejection fraction measurement, or diagnostic cardiac catheterization (at hospitals with catheterization laboratories). CONCLUSIONS: Most patients with NSTE ACS presenting to community hospitals without revascularization capabilities are not rapidly transferred to tertiary hospitals, and lower-risk patients appear to be preferentially transferred early. Further investigation is needed to determine if improved risk-based triage at community hospitals can optimize transfer decision making for high-risk patients with NSTE ACS.

Women tolerate drug therapy for coronary artery disease as well as men do, but are treated less frequently with aspirin, beta-blockers, or statins.

BACKGROUND: Women have worse morbidity, mortality, and health-related quality-of-life outcomes associated with coronary artery disease (CAD) compared with men. This may be related to underutilization of drug therapies, such as aspirin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, or statins. No studies have sought to describe the relationship of gender with adverse reactions to drug therapy (ADRs) for CAD in clinical practice. OBJECTIVE: The aim of this study was to determine the prevalence of ADRs associated with common CAD drug therapies in women and men in clinical practice. METHODS: In a cohort of consecutive outpatients with CAD, detailed chart abstraction was performed to determine the use of aspirin, beta-blocker, ACE inhibitor, and statin therapy, as well as the ADRs reported for these treatments. Baseline clinical characteristics were also determined to identify the independent association of gender with use of standard drug treatments for CAD. RESULTS: Consecutive patients with CAD (153 men, 151 women) were included in the study. Women and men were observed to have a similar prevalence of cardiac risk factors and comorbidities, except that men had significantly higher prevalence of atrial fibrillation (30 [19.6%] men vs 15 [9.9%] women; P = 0.03) and significantly lower mean (SD) high-density lipoprotein cholesterol concentrations (45 [16] mg/dL for men vs 55 [19] mg/dL for women; P < 0.001). No significant differences were observed between the sexes in the prevalence of ADRs; however, significantly fewer women than men were treated with statins (118 [78.1%] vs 139 [90.8%], respectively; P = 0.003). After adjusting for clinical characteristics, women were also found to be less likely than men to receive aspirin (odds ratio [OR] = 0.164; 95% CI, 0.083-0.322; P = 0.001) and beta-blockers (OR = 0.184; 95% CI, 0.096-0.351; P = 0.001). CONCLUSIONS: Women and men experienced a similar prevalence of ADRs in the treatment of CAD; however, women were significantly less likely to be treated with aspirin, beta-blockers, and statins than were their male counterparts. To optimize care for women with CAD, further study is needed to identify the cause of this gender disparity in therapeutic drug use.

Overcoming a perfect storm: an academic cardiology section's story of survival.

Increasingly, academic institutions are grappling with financial pressures that threaten the academic mission. The author presents an actual case history in which a section of cardiology in an academic health center was confronted with huge projected deficits that had to be eliminated within the fiscal year. The section used eight principles to shift from deficit to profitability (i.e., having revenue exceed costs). These principles included confronting the brutal facts, managing costs and revenue cycles, setting expectations for faculty, and quality improvement. The section accomplished deficit reduction through reducing faculty salaries (nearly $2 million) and nonfaculty salaries ($1.3 million) and reducing operational costs while maintaining revenues by increasing individual faculty productivity and reducing accounts receivable. In the face of these reductions, clinical revenues were maintained, but research revenue and productivity fell (but research is being fostered now that clinical services are profitable again). These principles can be used to stabilize the financial position of clinical practices in academic settings that are facing financial challenges.

Effective obesity treatments.

To curb the epidemic of obesity in the United States, revised Medicare policy allows support for efficacious obesity treatments. This review summarizes the evidence from rigorous randomized trials (9 lifestyle trials, 5 drug trials, and 2 surgical trials) on the efficacy and risk- benefit profile of lifestyle, drug, and surgical interventions aimed at promoting sustained (= 2 years) reductions in weight. Both lifestyle and drug interventions consistently produced an approximate 7-lb (3.2-kg) weight loss that was sustained for 2 years and was associated with improvements in diabetes, blood pressure, and/or cardiovascular risk factors. Surgical interventions have a less solid empirical base but offer promise for the promotion of significant and sustained weight reduction posttreatment in the morbidly obese but with possible significant short-term side effects. In summary, there is strong and consistent support from rigorous randomized trials that lifestyle or drug interventions result in modest weight loss with minimal risks but disproportionate clinical benefit. Combinations of lifestyle, drug, and, where appropriate, surgical interventions may be the most efficacious approach to achieving sustained weight loss for the widest diversity of patients.

Elements of nonpharmacologic interventions that prevent progression of heart failure: a meta-analysis.

This review examined whether nonpharmacologic treatment was associated with reductions in all-cause mortality and heart failure (HF) hospitalizations and investigated the effects of face-to-face contact and longer treatment duration on these outcomes. MEDLINE and PsycINFO databases were searched through June 2006 and bibliographies of potential articles were hand-searched. Nonpharmacologic treatment was associated with significantly lower odds of HF hospitalizations (odds ratio [OR], 0.41; 95% confidence interval [CI], 0.30-0.56) and death (OR, 0.69; 95% CI, 0.56-0.85) compared with control treatment. Face-to-face contact was associated with significantly lower odds of HF hospitalization (OR, 0.42; 95% CI, 0.22-0.81; P<.05) and death (OR, 0.63; 95% CI, 0.44-0.91; P<.05) as compared with control treatment. Longer treatment duration (>or=12 months) was associated with a 65% reduction in the rate of HF hospitalizations and a 36% reduction in death rate. Nonpharmacologic treatment featuring face-to-face contact is particularly effective in reducing HF hospitalization and all-cause mortality rates.

A new approach for low-cost noninvasive detection of asymptomatic heart disease at rest.

It would be useful to have an inexpensive, noninvasive point-of-care test for early detection of asymptomatic heart disease. This study used impedance cardiography (ICG) in a new way to assess heart function that did not use stroke volume or cardiac output. There is a model of the ICG dZ/dt waveform that may be used as a template to represent normal heart function. The hypothesis was that a dZ/dt waveform which deviates from that template should indicate heart dysfunction and therefore heart disease. The objective was to assess the accuracy of this new ICG approach, using echocardiography as the standard. Thirty-four outpatients undergoing echocardiographic testing were tested by ICG while sitting upright and supine. All patients had no symptoms or history of a structural or functional heart disorder. Echocardiographic testing showed 17 patients with abnormalities and 17 as normal. ICG testing yielded 16 true positives for heart dysfunction with 1 false negative (sensitivity = 94%) and 17 true negatives with no false positives (specificity = 100%). Considering that the cost, technical skill, and time required for this ICG test are comparable to those of an electrocardiograph, this new approach has potential as a point-of-care screening test for asymptomatic heart disease.

Insurance coverage and care of patients with non-ST-segment elevation acute coronary syndromes.

BACKGROUND: The impact of insurance coverage on the care of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unclear. OBJECTIVE: To compare NSTE ACS care patterns by insurance type. DESIGN: Comparison of Medicaid patients younger than 65 years of age and Medicare patients 65 years of age or older with patients of similar age who have health maintenance organization (HMO) or private insurance coverage. SETTING: 521 U.S. hospitals participating in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress ADverse Outcomes with Early Implementation of the ACC [American College of Cardiology]/AHA [American Heart Association] Guidelines) quality improvement initiative from January 2001 through March 2005. PATIENTS: 37,345 NSTE ACS patients younger than 65 years of age and 59,550 patients 65 years of age or older. MEASUREMENTS: Guideline-recommended treatments, and in-hospital outcomes. RESULTS: Medicaid was the primary payer for 18.7% (6999 of 37,345) of patients younger than age 65 years, whereas Medicare was the primary payer for 67.5% (40,199 of 59,550) of patients age 65 years or older. Medicaid patients were statistically significantly less likely to receive short-term (less than 24 hours) medications and to undergo invasive cardiac procedures than patients covered by HMO and private insurance. They also had higher mortality rates (2.9% vs. 1.2%; adjusted odds ratio, 1.33; 95% CI, 1.08 to 1.63). Medications and invasive procedures were used to a similar extent in patients with Medicare and HMO or private insurance, and respective mortality rates were not significantly different (6.2% vs. 5.6%; adjusted odds ratio, 1.08; 95% CI, 0.99 to 1.18). LIMITATIONS: Self-pay patients and patients without insurance were not assessed. CONCLUSIONS: NSTE ACS patients with Medicaid (but not Medicare) as the primary payer were less likely to receive evidence-based therapies and had worse outcomes than patients with HMO or private insurance as the primary payer. The causes of these treatment differences and solutions for narrowing the gaps in quality require further investigation.

Impedance cardiography: a comparison of cardiac output vs waveform analysis for assessing left ventricular systolic dysfunction.

Early detection of asymptomatic left ventricular systolic dysfunction (LVSD) is beneficial in managing heart failure. Recent studies have cast doubt on the usefulness of cardiac output as an indicator of LVSD. In impedance cardiography (ICG), the dZ/dt waveform has a systolic wave called the E wave. This study looked at measurements of the amplitude and area of the E wave compared with ICG-derived cardiac output, stroke volume, cardiac index, and stroke index as methods of assessing LVSD. ICG data were obtained from patients (n=26) admitted to a coronary care unit. Clinical LVSD severity was stratified into 4 groups (none, mild, moderate, and severe) based on echocardiography data and standard clinical assessment by a cardiologist blinded to ICG data. Statistical analysis showed that the E wave amplitude and area were better indicators of the level of LVSD than cardiac output, stroke volume, cardiac index, or stroke index. ICG waveform analysis has potential as a simple point-of-care test for detecting LVSD in asymptomatic patients at high risk for developing heart failure and for monitoring LVSD in patients being treated for heart failure.

Prediction of medical morbidity and mortality after acute myocardial infarction in patients at increased psychosocial risk in the Enhancing Recovery in Coronary Heart Disease Patients (ENRICHD) study.

BACKGROUND: Patients with myocardial infarction (MI) are at further increased risk for untoward events when patients also exhibit low social support and/or depression. The ENRICHD study was the largest controlled trial in post-MI patients attempting to treat these psychological comorbidities and provides an opportunity to examine the medical and psychological characteristics that may affect risk in this population. METHODS: We analyzed the baseline characteristics and their relationship to the primary end point of long-term mortality and recurrent infarction and to the secondary end points of overall mortality and cardiovascular mortality in 2481 post-MI patients. Cox proportional hazards models were used to predict the risk of these outcomes over a mean of 2.5 years of follow-up. RESULTS: Death or nonfatal MI occurred in 24.1%, all-cause mortality in 13.7%, and cardiovascular mortality in 8.4% of the sample (62% of the total). Age, heart failure, pulmonary disease, Killip class, ejection fraction, an elevated creatinine, the use of non-angiotensin-coverting enzyme asodilators, prior MI, diabetes, depression, and bypass surgery after acute MI were all significant multivariable predictors. CONCLUSIONS: The medical predictors of adverse events in post-MI patients with low social support and/or depression were similar to those of patients with MI in other clinical trials.

Understanding African-American participation in a behavioral intervention: results from focus groups.

Heart failure (HF) is an increasingly prevalent condition contributing to significant morbidity and mortality among African-Americans. The Heart Failure Adherence and Retention Trial (HART) is the largest NHLBI funded behavioral clinical trial of patients with HF (R01 HL65547). The HART trial has recruited approximately 40% minority participants, with 33% being African-American. The purpose of this qualitative study is to conduct an in-depth examination of the subjective experience of African-American participants in the intervention arm of the HART. Five focus groups were conducted with a total of 25 participants. The mean age of those attending was 55 years, with a range between 39 and 82 years, 52% of the participants were female, and 92% were African-American. Participants gained overall general medical knowledge about HF and how HF influenced their own lives. Participants appeared not only to understand the self-management skills that were taught; but also how to apply them. They also demonstrated understanding of the connection between lifestyle and HF. Factors that may promote retention include mutual support, the opportunity to engage in meaningful social activity, and feeling cared for. Factors that may limit retention include anxiety and denial about HF and logistical and emotional barriers to attending groups. Factors with unclear effects on retention include remuneration, ethnicity of the group leader, and the role of religious or spiritual content in meetings. While a number of perceived benefits exist to group participation, there are significant and logistical barriers to retention. Ongoing attention to cultural sensitivity is a likely factor in successful retention of study participants.

Posttraumatic stress and depression: potential pathways to disease burden among heart failure patients.

BACKGROUND AND OBJECTIVES: Posttraumatic stress disorder (PTSD) and Major Depressive Disorder (MDD) are associated with high disease burden. Pathways by which PTSD and MDD contribute to disease burden are not understood. DESIGN: Path analysis was used to examine pathways between PTSD symptoms, MDD symptoms, and disease burden among 251 low-income heart failure patients. METHODS: In Model 1, we explored the independent relationship between PTSD and MDD symptoms on disease burden. In Model 2, we examined the association of PTSD symptoms and disease burden on MDD symptoms. We also examined indirect associations of PTSD symptoms on MDD symptoms, mediated by disease burden, and of PTSD symptoms on disease burden mediated by MDD symptoms. RESULTS: Disease burden correlated with PTSD symptoms (r = .41; p < .001) and MDD symptoms (r = .43; p < .001) symptoms. Both models fit the data well and displayed comparable fit. MDD symptoms did not mediate the association of PTSD symptoms with disease burden. Disease burden did mediate the relationship between PTSD symptoms and MDD symptoms. CONCLUSIONS: Results support the importance of detection of PTSD in individuals with disease. Results also provide preliminary models for testing longitudinal data in future studies.

Traumatic stress and cardiopulmonary disease burden among low-income, urban heart failure patients.

BACKGROUND: Traumatic events and posttraumatic stress disorder (PTSD) are associated with increased risk for cardiopulmonary disease (CPD) in veterans, men, and primarily White populations. Less is known about trauma, PTSD, and CPD burden among low-income, racial minority residents who are at elevated risk for trauma and PTSD. It was hypothesized that traumatic events and PTSD would be significantly associated with CPD burden among low-income, racial minority residents. METHODS: We evaluated cross-sectional relationships between traumatic events, PTSD, depression, and CPD burden in 251 low-income, urban, primarily Black adults diagnosed with heart failure. Data were analyzed using bivariate analyses, logistic and linear regression. RESULTS: Forty-three percent endorsed at least one traumatic event. Twenty-one percent endorsed two or more traumatic events. In logistic regression analyses, traumatic events were associated with increased prevalence of coronary artery disease (adjusted odds=1.33, p<.05), hypertension (adjusted odds=1.28, p<.05), chronic obstructive pulmonary disease (adjusted odds=1.52, p<.01), and cardiac arrest (adjusted odds=1.27, p<.05). PTSD was also related to increased risk for chronic obstructive pulmonary disease (adjusted odds=1.22, p<.05) and was associated with earlier onset of heart failure (ß=-.13, p<.05). LIMITATIONS: The study utilizes cross-sectional, self-report data. CONCLUSIONS: Findings support the link between traumatic events, PTSD, and CPD burden in low-income, primarily Black patients with heart failure. Depression appears to be less closely linked to CPD burden, despite receiving significant attention in the literature. The accumulation of traumatic events may exacerbate CPD burden among urban, low-income, racial minority residents with heart failure; findings highlight the importance of PTSD screening.