Fostering creativity: how the Duke Graduate Medical Education Quasi-Endowment encourages innovation in GME.

The Duke Medicine Graduate Medical Education Quasi-Endowment, established in 2006, provides infrastructure support and encourages educational innovation. The authors describe Duke's experience with the "grassroots innovation" part of the fund, the Duke Innovation Fund, and discuss the Innovation Fund's processes for application, review, and implementation, and also outcomes, impact, and intended and unintended consequences.In the five years of the Innovation Fund described (2007-2011), 105 projects have been submitted, and 78 have been funded. Thirty-seven projects have been completed. Approved funding ranged from $2,363 to $348,750, with an average award of $66,391. This represents 42% of funding originally requested. Funding could be requested for a period of 6 months to 3 years. The average duration of projects was 27 months, with a range from 6 months to 36 months. Eighty percent of projects were completed on time. Two projects were closed because of lack of progress and failure to adhere to reporting requirements. Thirty-nine are ongoing.Program directors report great success in meeting project outcomes and concrete impacts on resident and faculty attitudes and performance. Ninety-two percent report that their projects would have never been accomplished without this funding. Projects have resulted in at least 68 posters, abstracts, and peer-reviewed presentations. At least 12 peer-reviewed manuscripts were published.There has been tremendous diversity of projects; all 13 clinical departments have been represented. Interdepartmental and intradepartmental program cooperation has increased. This modest seed money has resulted in demonstrable sustainable impacts on teaching and learning, and increased morale and scholarly recognition.

Association of depression and survival in patients with chronic heart failure over 12 Years.

OBJECTIVE: To examine the relationship between depression and survival in patients with chronic heart failure (HF) over a 12-year follow-up period. BACKGROUND: The survival associated with depression has been demonstrated in HF patients for up to 7 years. Longer-term impact of depression on survival of these patients remains unknown. METHODS: Prospectively conducted observational study examining adults with HF who were admitted to a cardiology service at Duke University Medical Center between March 1997 and June 2003 and completed the Beck depression inventory (BDI) scale. The national death index was queried for vital status. Cox proportional hazards modeling was used to determine the association of survival and depression. RESULTS: During a mean follow-up of 1792.33 ± 1372.82 days (median 1600; range 0-4683), 733 of 985 participants with HF died of all causes, representing 80% of those with depression (BDI > 10) and 73% of those without (P = 0.01). Depression was significantly and persistently associated with decreased survival over follow-up (hazard ratio [HR] 1.35, 95% confidence interval [CI] 1.15-1.57), and was independent of conventional risk factors (HR 1.40, 95% CI 1.16-1.68). Furthermore, survival was inversely associated with depression severity (BDI (continuous) HR 1.02, 95% CI 1.006-1.025, P = 0.001). CONCLUSIONS: The impact of co-morbid depression during the index hospitalization on significantly increased mortality of HF patients is strong and persists over 12 years. These findings suggest that more investigation is needed to understand the trajectory of depression and the mechanisms underlying the impact of depression as well as to identify effective management strategies for depression of patients with HF.

Characteristics of depression remission and its relation with cardiovascular outcome among patients with chronic heart failure (from the SADHART-CHF Study).

Depression is prevalent in patients with heart failure and is associated with a significant increase in hospitalizations and death. Primary results of the Sertraline Against Depression and Heart Disease in Chronic Heart Failure (SADHART-CHF) trial revealed that sertraline and placebo had comparable effects on depression and cardiovascular outcomes. In this study, we explored whether remission from depression was associated with better survival and aimed to characterize participants who remitted during the trial. Based on depression response during the 12-week treatment phase, SADHART-CHF participants were divided into 2 groups: (1) remission, defined as participants whose last measured Hamilton Depression Rating Scale (HDRS) score was <8, and (2) nonremission, defined as participants whose last measured HDRS score was ≥8. Patients who dropped out before having any repeat HDRS were not included. Baseline characteristics and survival differences up to 5 years were evaluated between the remission and nonremission groups. Of the 469 SADHART-CHF participants, 208 (44.3%) achieved remission, 194 (41.4%) remained depressed, and 67 (14.3%) dropped out or died without any repeat HDRS assessment. Patients in the remission group had significantly fewer cardiovascular events than those in the nonremission group (1.34 ± 1.86 vs 1.93 ± 2.71, adjusted p = 0.01). Men patients were more likely to remit than women patients (56.5 vs 44.8%, p = 0.02). The remission group had milder depressive symptoms at baseline compared to the nonremission group (HDRS 17.0 ± 5.4 vs 19.6 ± 5.5, Beck Depression Inventory scale 17.9 ± 6.5 vs 20.3 ± 7.2, p <0.001 for the 2 comparisons). In conclusion, this study indicates that remission from depression may improve the cardiovascular outcome of patients with heart failure.

Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial.

OBJECTIVES: The objective was to test the hypothesis that heart failure (HF) patients treated with sertraline will have lower depression scores and fewer cardiovascular events compared with placebo. BACKGROUND: Depression is common among HF patients. It is associated with increased hospitalization and mortality. METHODS: The SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial was a randomized, double-blind, placebo-controlled trial of sertraline 50 to 200 mg/day versus matching placebo for 12 weeks. All participants also received nurse-facilitated support. Eligible patients were age 45 years or older with HF (left ventricular ejection fraction < or =45%, New York Heart Association functional class II to IV) and clinical depression (Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for current major depressive disorder). Those with significant cognitive impairment, psychosis, recent alcohol or drug dependence, bipolar or severe personality disorder, active suicidal ideation, and current antipsychotic or antidepressant medications were excluded. Primary end points were change in depression severity (Hamilton Depression Rating Scale total score) and composite cardiovascular status at 12 weeks. RESULTS: A total of 469 patients were randomized (n = 234 sertraline, n = 235 placebo). The mean +/- SE change from baseline to 12 weeks in the Hamilton Depression Rating Scale total score was -7.1 +/- 0.5 (sertraline) and -6.8 +/- 0.5 (placebo) (p < 0.001 from baseline, p = 0.89 between groups, mean change between groups -0.4; 95% confidence interval: -1.7 to 0.92). The proportions whose composite cardiovascular score worsened, improved, or was unchanged were 29.9%, 40.6%, and 29.5%, respectively, in the sertraline group and 31.1%, 43.8%, and 25.1%, respectively, in the placebo group (p = 0.78). CONCLUSIONS: Sertraline was safe in patients with significant HF. However, treatment with sertraline compared with placebo did not provide greater reduction in depression or improved cardiovascular status among patients with HF and depression. (Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure [SADHART-CHF]; NCT00078286).

Blending technology and teamwork for successful management of product recalls.

Patient safety programs have been developed in many hospitals to reduce the risk of harm to patients. Proactive, real-time, and retrospective risk-reduction strategies should be implemented in hospitals, but patient safety leaders should also be cognizant of the risks associated with thousands of products that enter the hospital through the supply chain. A growing number of recalls and alerts related to these products are received by health care facilities each year, through a recall process that is fraught with challenges. Despite the best efforts of health care providers, weaknesses and gaps in the process lead to delays, fragmentation, and disruptions, thus extending the number of days patients may be at risk from potentially faulty or misused products. To address these concerns, Duke Medicine, which comprises an academic medical center, two community hospitals, outlying clinics, physicians' offices, and home health and hospice, implemented a Web-based recall management system. Within three months, the time required to receive, deliver, and close alerts decreased from 43 days to 2.74 days. To maximize the effectiveness of the recall management process, a team of senior Duke Medicine leaders was established to evaluate the impact of product recalls and alerts on patient safety, to evaluate response action plans, and to provide oversight of patient and provider communication strategies. Alerts are now communicated more effectively and responded to in a more consistent and global manner. This comprehensive approach to product recalls is a critical component of a broader Duke Medicine strategy to improve patient safety.

Perspective: Autonomic care systems for hospitalized patients.

With advancements of medical technology and improved diagnostic and treatment options, children with severe birth defects who would otherwise have no chance of surviving post birth survive to go home every day. The average lifespan in the United States has increased substantially over the last century. These successes and many other medical breakthroughs in managing complex illnesses, particularly in frail, elderly patients, have resulted in an increasing percentage of patients with comorbidities. This, coupled with a policy change by Medicare (i.e., Medicare will no longer reimburse hospitals for costs associated with treating preventable errors and injuries that a patient acquires while in the hospital), creates an enormous challenge to health care providers. To meet the challenge, the authors propose a new model of health care--the autonomic care system (ACS)--a concept derived from the intensive care unit and the autonomic computing initiative in the computer industry. Using wound care as an example, the authors examine the necessity, feasibility, design, and challenges related to ACS. Specifically, they discuss the role of the human operator, the potential combination of ACS and existing hospital information technology (e.g., electronic medical records and computerized provider order entry), and the costs associated with ACS. ACS may serve as a roadmap to revamp the health care system, bringing down the barriers among different specialties and improving the quality of care for each problem for all hospitalized patients.

The Support, Education, and Research in Chronic Heart Failure Study (SEARCH): a mindfulness-based psychoeducational intervention improves depression and clinical symptoms in patients with chronic heart failure.

BACKGROUND: The Support, Education, and Research in Chronic Heart Failure (SEARCH) study was designed to assess the impact of a mindfulness-based psychoeducational intervention on clinical outcomes, depression, and quality of life in patients with chronic heart failure (CHF). Although research has shown that psychosocial factors including depression are important risk factors for adverse events in patients with CHF, no large clinical trials have investigated the efficacy of psychosocial interventions to reduce these factors in this population. METHODS: This was a prospective cohort study of 208 adults with left ventricular ejection fraction < or =40% and CHF geographically assigned to treatment or control groups with follow-up at 3, 6, and 12 months. Treatment groups met weekly for 8 consecutive weeks for training in mindfulness meditation, coping skills, and support group discussion. RESULTS: Subjects had a mean age of 61 years, left ventricular ejection fraction 26%, and median New York Heart Association class II. The majority were treated with angiotensin-converting enzyme inhibitors (80%) and beta-blockers (86%). At baseline, patients in the treatment group had more severe CHF with higher New York Heart Association class (P = .0209) and more severe psychological distress (Center of Epidemiology - Depression, Profile of Mood States; P < .05). When compared with controls, treatment resulted in lower anxiety (Profile of Mood States, P = .003), depression (Center of Epidemiology - Depression, P = .05), improved symptoms (Kansas City Cardiomyopathy Questionnaire symptom scale, P = .033) and clinical scores (Kansas City Cardiomyopathy Questionnaire clinical score, P = .024) over time. There were no treatment effects on death/rehospitalization at 1 year. CONCLUSIONS: An 8-week mindfulness-based psychoeducational intervention reduced anxiety and depression; this effect was attenuated at 1 year. Importantly, the intervention led to significantly better symptoms of CHF at 12 months compared to control subjects. Our results suggest that interventions of this type might have a role in optimal therapy for CHF.

Antidepressant use, depression, and survival in patients with heart failure.

BACKGROUND: Recent studies suggest that the use of antidepressants may be associated with increased mortality in patients with cardiac disease. Because depression has also been shown to be associated with increased mortality in these patients, it remains unclear if this association is attributable to the use of antidepressants or to depression. METHODS: To evaluate the association of long-term mortality with antidepressant use and depression, we studied 1006 patients aged 18 years or older with clinical heart failure and an ejection fraction of 35% or less (62% with ischemic disease) between March 1997 and June 2003. The patients were followed up for vital status annually thereafter. Depression status, which was assessed by the Beck Depression Inventory (BDI) scale and use of antidepressants, was prospectively collected. The main outcome of interest was long-term mortality. RESULTS: Of the study patients, 30.0% were depressed (defined by a BDI score > or =10) and 24.2% were taking antidepressants (79.6% of these patients were taking selective serotonin reuptake inhibitors [SSRIs] only). The vital status was obtained from all participants at an average follow-up of 972 (731) (mean [SD]) days. During this period, 42.7% of the participants died. Overall, the use of antidepressants (unadjusted hazard ratio [HR], 1.32; 95% confidence interval [CI], 1.03-1.69) or SSRIs only (unadjusted HR, 1.32; 95% CI, 0.99-1.74) was associated with increased mortality. However, the association between antidepressant use (HR, 1.24; 95% CI, 0.94-1.64) and increased mortality no longer existed after depression and other confounders were controlled for. Nonetheless, depression remained associated with increased mortality (HR, 1.33; 95% CI, 1.07-1.66). Similarly, depression (HR, 1.34; 95% CI, 1.08-1.68) rather than SSRI use (HR, 1.10; 95% CI, 0.81-1.50) was independently associated with increased mortality after adjustment. CONCLUSION: Our findings suggest that depression (defined by a BDI score > or =10), but not antidepressant use, is associated with increased mortality in patients with heart failure.

Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure.

BACKGROUND: Sertraline, a selective serotonin-reuptake inhibitor, has demonstrated substantial mood improvement in patients with post myocardial infarction or with unstable angina. The impact of sertraline on the prognosis and depression of patients with chronic heart failure (HF) and comorbid major depressive disorder (MDD) is unknown. METHOD: This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of sertraline in the treatment of MDD in patients with HF. The study is designed also to examine the effects of treating depression on cardiac events and morbidity/mortality in patients with HF. Approximately 500 men and women who are >or=45 years of age with current MDD and chronic systolic HF, characterized by left ventricular ejection fraction or=II, comprise the study population. Eligible participants are randomized to either sertraline or placebo for a 12-week acute treatment phase. All patients, regardless of acute treatment phase completion, are followed routinely until the last subject completes 6-month follow-up. Quality of life and certain physiologic parameters, as well as pro-inflammatory and HF biomarkers, that may reflect the impact of sertraline in this particular population are measured at baseline and at the end of the acute treatment phase. CONCLUSION: Because of the high prevalence of depression and its significant adverse impact on prognosis of patients with ischemic heart disease (IHD) and HF, the Safety and Efficacy of Sertraline for Depression in Patients with Chronic Heart Failure (SADHART-CHF) trial aims to assess the effects of sertraline on response of depression as well as on the cardiac prognosis of patients with HF.

Relationship between depressive symptoms and long-term mortality in patients with heart failure.

BACKGROUND: Depression is prevalent in patients with heart failure (HF) and is associated with short-term poor prognosis. However, the long-term effect of depression and the use of self-administered depression evaluation on HF prognosis remained unknown. The study sought to assess the association of depressive symptoms and long-term mortality of patients with HF and to explore the prognostic predictability of the Beck Depression Inventory (BDI) scale for patients with HF. METHODS: Hospitalized patients with HF between March 1997 and June 2003 were recruited. All participants were given the self-administered BDI scale for depression assessment during the index admission. They were then followed for 6 months for the collection of vital status, and annually thereafter. RESULTS: Total study population comprises 1006 patients. The mean BDI score was 8.3 +/- 7.1. The average days of follow-up were 971 +/- 730 and the vital status was obtained from all participants. During this period, 42.6% of the participants died. Depression (defined by BDI score > or = 10) was significantly and independently associated with reduced survival (adjusted hazard ratio 1.36, 95% CI 1.09-1.70, P < .001). Patients whose BDI scores were 5 to 9, 10 to 18, and > or = 19 were 21%, 53%, and 83% more likely to die, respectively, than patients whose BDI score was < 5 (P < .001). CONCLUSIONS: Self-rated depression by BDI is independently linked with higher long-term mortality in patients with HF. Significant dose effect of depressive symptoms on higher mortality is noted.

Racial differences in the characteristics of patients admitted for acute decompensated heart failure and their relation to outcomes: results from the OPTIME-CHF trial.

BACKGROUND: Recent data suggest that differences in response to therapy and survival exist between African Americans and Caucasians with heart failure. Whether these differences exist in acute decompensated heart failure (ADHF) is uncertain. METHODS AND RESULTS: We analyzed data from the OPTIME-CHF (Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure) study, a randomized trial of intravenous milrinone versus placebo in 949 patients hospitalized with ADHF. We evaluated differences in clinical characteristics, outcomes, and response to milrinone therapy in African American patients compared with Caucasians. The primary end point of OPTIME-CHF was days hospitalized for cardiovascular causes or death within 60 days of randomization. Thirty-three percent (n = 310) of patients were African American. African American patients were younger (57 vs. 70 years, P < .0001) and more likely to have non-ischemic cardiomyopathy (74% vs. 36%, P < .0001). In unadjusted analysis, African American patients had a lower 60-day mortality (5% vs. 12%, P = .0004) and tended to have better overall clinical outcomes. After adjustment for baseline differences, however, these differences were no longer significant. We found no differential effect of milrinone therapy by race. CONCLUSION: African American patients with acute decompensated heart failure present with a different clinical profile than Caucasian patients. Although unadjusted clinical outcomes are better for African Americans presenting with ADHF, these differences diminished after adjustment for baseline characteristics.

Endothelial progenitor cell therapy for atherosclerosis: the philosopher's stone for an aging population?

Much of the increased risk for atherosclerosis progression with age may be a result of age-related declines in the capacity of precursor cells to repair damage in the arterial endothelium. To estimate the impact of progenitor cell therapy for atherosclerosis on cardiovascular disease (CVD) mortality, life expectancy, and survival, as compared with the lifetime control of conventional risk factors, we modeled the health effects of bone marrow-derived endothelial progenitor cell therapy using data from the 1950 to 1996 follow-up of the Framingham Heart Study. To model cardiovascular disease mortality, we assumed that progenitor cell therapy was applied at age 30, with the effect assumed to be a 10-year delay in atherosclerosis progression. Age projections were constructed analytically using the stochastic process model for risk factor dynamics and mortality and microsimulation techniques. We considered three types of interventions: (i) keeping risk factors within selected limits to model current clinical recommendations; (ii) an age shift of 10 years to model the effects of progenitor cell therapy; and (iii) elimination of a competing risk (such as cancer). Our study suggests that progenitor cell therapy might increase life expectancy in the population as much as the complete elimination of cancer (in females, an additional 3.67 versus 3.37 years; in males, an additional 5.94 versus 2.86 years, respectively).

Variations in coronary procedure utilization depending on body mass index.

BACKGROUND: Increased body mass index (BMI) (calculated as weight in kilograms divided by the square of height in meters) is a risk factor for coronary heart disease and is associated with lower preventive services utilization. The relationship between BMI and utilization of diagnostic or therapeutic procedures for coronary heart disease has not been examined. METHODS: We evaluated 109 664 Medicare patients who were hospitalized for acute myocardial infarction in a nongovernmental acute care hospital between 1994 and 1996, were 65 years or older, and weighed 159 kg or less. We used logistic regression to examine the relationship of BMI with utilization of cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass grafting while adjusting for patient and hospital characteristics. RESULTS: Participants had a mean age of 75.8 years; 53% were men and 90% were white. Individuals with a BMI of 25.0 to 35.0 had the highest rates of coronary procedure utilization. Compared with patients with a BMI of 25.0 to 29.9, those with a BMI of 35.0 to 39.9 had a reduced adjusted odds ratio (OR) of receiving coronary artery bypass grafting (OR, 0.88; 95% confidence interval [CI], 0.79-0.98), whereas patients with a BMI of 40.0 or greater had the lowest odds of receiving cardiac catheterization (OR, 0.82; 95% CI, 0.73-0.92), percutaneous coronary intervention (OR, 0.89; 95% CI, 0.77-1.03), and coronary artery bypass grafting (OR, 0.68; 95% CI, 0.57-0.82). Patients who did not receive coronary revascularization had higher mortality rates than those who did. CONCLUSIONS: For patients hospitalized with acute myocardial infarction, those with a very high BMI were less likely to receive invasive coronary procedures. Future research should investigate reasons for these variations in coronary procedure utilization.

Risk stratification after hospitalization for decompensated heart failure.

BACKGROUND: Decompensated heart failure (HF) is among the most common indications for hospitalization in the United States, but little is known about features on admission that predict adverse events. We used data from the Outcomes of a Prospective Trial of Intravenous Milrinone for Exacerbations of Chronic Heart Failure (OPTIME-CHF) study to develop a model that would predict outcomes in patients with decompensated HF. METHODS AND RESULTS: OPTIME-CHF randomized 949 patients hospitalized with decompensated HF for 48 to 72 hours of infusion of either milrinone or placebo. We used multivariable modeling to evaluate variables on admission that would be predictive of 60-day mortality or the composite of death or rehospitalization at 60 days. Variables at presentation that predicted death at 60 days were increased age, lower systolic blood pressure, New York Heart Association class IV symptoms, elevated blood urea nitrogen (BUN), and decreased sodium. Predictors of the composite of death or rehospitalization within 60 days were the number of HF hospitalizations in the preceding 12 months, elevated BUN, lower systolic blood pressure, decreased hemoglobin, and a history of percutaneous coronary intervention (PCI). The discriminatory power of the model was substantial for the mortality model (c-index .77) but less for the composite endpoint (c-index .69). CONCLUSIONS: Risk stratification of patients with decompensated HF may be accomplished using easily assessed clinical variables. Further research into the validity of this model in independent samples will potentially aid in the development of risk stratification strategies.

Prognostic value of anxiety and depression in patients with chronic heart failure.

BACKGROUND: Anxiety is often present with depression and may be one of its manifestations. Although the adverse effects of depression in patients with chronic heart failure (CHF) have been well studied, the relation between anxiety and CHF prognosis has not been addressed. In a secondary analysis of data collected for a published study of depression and prognosis in patients with CHF, we examined the relations among anxiety, depression, and prognosis. METHODS AND RESULTS: We measured symptoms of anxiety with the Spielberger State-Trait Anxiety Inventory (STAI) scale and symptoms of depression with the Beck Depression Inventory (BDI) scale in 291 patients with CHF hospitalized as a result of cardiac events. We followed up these patients for all-cause mortality over 1 year. The mean scores for state anxiety (State-A) and trait anxiety (Trait-A) were identical at 33.5; the mean BDI score was 8.7+/-7.6. State-A and Trait-A scores correlated highly with each other (r=0.85; P<0.01) and with BDI score (State-A, r=0.52; Trait-A, r=0.59; P<0.01). Cox proportional-hazards model with and without confounding variables showed no relation between State-A or Trait-A and 1-year mortality. BDI scores, however, significantly predicted increased mortality during 1-year follow-up (hazard ratio, 1.04 for each 1-unit increase; P<0.01). CONCLUSIONS: Although anxiety and depression are highly correlated in CHF patients, depression alone predicts a significantly worse prognosis for these patients.

The association between depression and chronic kidney disease and mortality among patients hospitalized with congestive heart failure.

BACKGROUND: The point prevalence of depression and its relationship to poor outcomes among patients with chronic kidney disease (CKD) has not been fully characterized. METHODS: We performed a secondary analysis of a prospective cohort of 374 patients admitted with congestive heart failure between March 1, 1997 and June 30, 1998, to investigate the point prevalence of depression among patients with CKD and its association with mortality. The Beck Depression Inventory (BDI) was administered to all patients. Those who scored 10 or higher were administered the National Institute of Mental Health Diagnostic Interview Schedule (DIS). Logistic regression was used to examine the association between severe CKD, corresponding to a creatinine clearance less than 30 mL/min/72 kg (<0.50 mL/s/72 kg), depression, and mortality at 1 year. RESULTS: Point prevalences of depressive symptoms by BDI and major depression by DIS were 54.8% and 21.6% if severe CKD was present and 32.8% and 13.0% if severe CKD was absent, respectively. After controlling for important clinical factors, severe CKD was associated with depressive symptoms by BDI (odds ratio, 2.89; 95% confidence interval, 1.39 to 5.99). Both depression by DIS and severe CKD were significant predictors of mortality. The increased mortality risk associated with depression did not decline with decreasing kidney function. CONCLUSION: Depression was more prevalent among patients with than without severe CKD and had at least as strong an association with mortality as compared with depression in patients with no or less severe CKD. The point prevalence of depression decreased when the DIS interview was used, perhaps related to the presence of somatic measures on the BDI reflecting uremia. Studies assessing the efficacy of antidepressants among patients with CKD are needed to determine whether, in addition to treating depression, pharmacotherapy impacts mortality.