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PublicationMOTIVATional intErviewing to Improve Self-Care in Heart Failure Patients (MOTIVATE-HF): Study Protocol of a Three-Arm Multicenter Randomized Controlled Trial(2017-04-01) Vellone, Ercole; Paturzo, Marco; D'Agostino, Fabio; Petruzzo, Antonio; Masci, Stefano; Ausili, Davide; Rebora, Paola; Alvaro, Rosaria; Riegel, BarbaraAims Heart Failure (HF) self-care improves patient outcomes but trials designed to improve HF self-care have shown inconsistent results. Interventions may be more effective in improving self-care if they mobilize support from providers, promote self-efficacy, increase understanding of HF, increase the family involvement, and are individualized. All of these elements are emphasized in motivational interviewing (MI); few trials have been conducted using MI in HF patients and rarely have caregivers been involved in MI interventions. The aim of this study will be to evaluate if MI improves self-care maintenance in HF patients, and to determine if MI improves the following secondary outcomes: a) in HF patients: self-care management, self-care confidence, symptom perception, quality of life, anxiety/depression, cognition, sleep quality, mutuality with caregiver, hospitalizations, use of emergency services, and mortality; b) in caregivers: caregiver contribution to self-care, quality of life, anxiety/depression, sleep, mutuality with patient, preparedness, and social support. Methods A three-arm randomized controlled trial will be conducted in a sample of 240 HF patients and caregivers. Patients and caregivers will be randomized to the following arms: 1) MI intervention to patients only; 2) MI intervention to patients and caregivers; 3) standard of care to patients and caregivers. The primary outcome will be measured in patients 3 months after enrollment. Primary and secondary outcomes also will be evaluated 6, 9 and 12 months after enrollment. Conclusion This study will contribute to understand if MI provided to patients and caregivers can improve self-care. Because HF is rising in prevalence, findings can be useful to reduce the burden of the disease. PublicationSocial Support and Self-Care of Patients with Heart Failure(2008-02-20) Sayers, Steven L; Riegel, Barbara; Pawlowski, Stephanie; Coyne, James C; Samaha, Frederick FBackground Social support can influence treatment adherence of patients with chronic illnesses, which may explain the positive effects of social support on heart failure (HF) outcomes. Purpose To investigate the effects of social support among patients with HF, we examined whether aspects of social support were associated with self-care, including medication adherence, dietary adherence, and HF symptom monitoring functions. Methods We recruited 74 patients with HF from cardiology clinics of a Veterans Affairs Medical Center and a university-affiliated hospital, and tested the relationships between social support and the patients' self-care. Results Consistent with previous research in older adults, family members, especially spouses, were often involved in the medical care of patients with chronic HF and provided a range of levels of support to patients. Self-care was generally poor, as measured across several self-care domains. Perceived social support was moderately associated with relatively better self-reported medication and dietary adherence, and other aspects of self-care such as daily weighing. Conclusions These findings suggest that a relatively higher level of self-care is an important correlate of social support and may explain how social support influences HF outcomes. This study also suggests that family members should play a greater part in clinical care focused on improving self-care. PublicationWho Listens to Our Advice? A Secondary Analysis of Data From a Clinical Trial Testing an Intervention Designed to Decrease Delay in Seeking Treatment for Acute Coronary Syndrome(2011-11-01) Riegel, Barbara; Elmi, Angelo; Moser, Debra K; McKinley, Sharon; Meischke, Hendricka; Doering, Lynn V; Davidson, Patricia; Pelter, Michele; Baker, Heather; Dracup, KathleenObjective Prolonged prehospital delay in persons experiencing acute coronary syndrome (ACS) remains a problem. Understanding which patients respond best to particular interventions designed to decrease delay time would provide mechanistic insights into the process by which interventions work. Methods In the PROMOTION trial, 3522 at-risk patients were enrolled from 5 sites in the United States (56.4%), Australia and New Zealand; 490 (N = 272 intervention, N = 218 control) had an acute event within 2 years. Focusing on these 490, we (1) identified predictors of a rapid response to symptoms, (2) identified intervention group subjects with a change in these predictors over 3 months of follow-up, and (3) compared intervention group participants with and without the favorable response pattern. Hypothesized predictors of rapid response were increased perceived control and decreased anxiety. Knowledge, attitudes, and beliefs were hypothesized to differ between responders and non-responders. Results Contrary to hypothesis, responders had low anxiety and low perceived control. Only 73 (26.8%) subjects showed this pattern 3 months following the intervention. No differences in ACS knowledge, attitudes, or beliefs were found. Conclusion The results of this study challenge existing beliefs. Practice implications New intervention approaches that focus on a realistic decrease in anxiety and perceived control are needed. PublicationCharacteristics and Outcomes of Serious Traumatic Injury in Older Adults(2002-02-01) Richmond, Therese S; Kauder, Donald R; Strumpf, Neville; Meredith, TammyObjectives: The aims were to: 1) describe the seriously injured older adult; 2) characterize and compare the differences in injury characteristics and outcomes in three subgroups of seriously injured older adults: 65-74 years, 75-84 years, and >85 years of age; 3) identify risk factors for death, complications, and discharge placement at hospital discharge. Design: A retrospective secondary analysis of a statewide trauma data set from 1988-1997. Setting: Data submitted from all designated trauma centers in Pennsylvania. Participants: The data set yielded 38,707 patients with a mean age of 77.5 years with serious injury (mean number of injuries = 3.6, mean number of body systems involved = 2). Measurements: Key outcomes were mortality, complications, and discharge placement. Abbreviated Injury Score categorized injuries and Injury Severity Score (ISS) quantified anatomic severity of injury. Results: Mortality was 10%. Mean length of stay 11.5 days. 52.2% of survivors were discharged home and 25.4% to a skilled nursing facility. Injury severity, total number of injuries, complications and increasing age were predictors of mortality (p<.01). The presence of pre-existing co-morbid medical conditions increased the odds of experiencing a complication over three-fold. Increasing age, total number of injuries, injury to extremities or abdominal contents, injuries due to falls, and lower functional level predicted discharge to a skilled nursing facility (p<.01). Conclusions: Traumatic injury in older adults are typically multisystem, life-threatening, and affects older adults of all ages. The standard ISS does not fully capture the potential for mortality in older adults and does not predict discharge placement. The majority of older adults survive multisystem injury. Our findings indicate the need to examine outcomes beyond mortality and to make the identification and management of co-morbid conditions a priority. A geriatric consultation service could be an important additional to the interdisciplinary trauma team. PublicationModifiable Factors Associated With Sleep Dysfunction in Adults With Heart Failure(2012-12-01) Riegel, BarbaraBackground: Sleep dysfunction contributes to poor quality of life in adults with heart failure (HF). The purpose of this study was to identify factors associated with sleep dysfunction that may be modifiable. Methods: Data were collected from 266 subjects enrolled from three sites in the U.S. Sleep dysfunction was measured over the past month with the Pittsburgh Sleep Quality Index, using a score > 10 to indicate sleep dysfunction. Potentially modifiable clinical, behavioral, and psychological factors thought to be associated with sleep dysfunction were analyzed with hierarchical logistic regression analysis. Results: When covariates of age, gender, race, data collection site, and New York Heart Association (NYHA) functional class were entered on the first step, only NYHA was a significant correlate of sleep dysfunction. When the clinical, behavioral, and psychological factors were entered, correlates of sleep dysfunction were the number of drugs known to cause daytime somnolence (OR = 2.08), depression (OR = 1.83), worse overall perceived health (OR = 1.64), and better sleep hygiene (OR = 1.40). Although most (54%) subjects had sleep disordered breathing (SDB), SDB was not a significant predictor of sleep dysfunction. Discussion: Factors associated with sleep dysfunction in HF include medications with sleepiness as a side-effect, depression, poorer health perceptions, and better sleep hygiene. Sleep dysfunction may motivate HF patients to address sleep hygiene. Eliminating medications with sleepiness as a side-effect, treating depression and perceptions of poor health may improve sleep quality in HF patients. PublicationThe Case for Enhanced Data Collection of Gun Type(2004-01-01) Richmond, Therese S; Branas, Charles; Cheney, Rose Ann; Schwab, C WilliamBackground: National surveillance systems have differentiated long guns into rifles and shotguns but fail to do so for handgun type. We sought to determine whether specific gun type data could be collected and whether knowledge of specific gun types (rifle, shotgun, pistol, revolver) could be used to distinguish gun homicide victims with respect to important injury parameters such as number of wounds. Methods: Data on gun fatalities over a 5-year period in three communities were abstracted from medical examiner/coroner, police, and crime laboratory records. Results: Gun type was obtained for 92% of 490 guns linked to 405 gun homicides. Handguns were associated with more wounds per gun than long guns (p = 0.001) and more entry wounds per gun than long guns (p = 0.002). Among handguns, pistols were associated with more wounds per gun (p < 0.001) and entry wounds per gun (p = 0.001) than revolvers. These same associations were not found among specific long gun types (i.e., rifles and shotguns). Conclusion: Our findings demonstrate that information about gun type can be obtained and that significant differences exist in wounds per gun between long guns and handguns and between pistols and revolvers. Classification of long guns into rifles and shotguns and handguns into pistols and revolvers should be included in local, regional, and national data collection systems. PublicationQualitative Analysis of Naturalistic Decision Making in Adults with Chronic Heart Failure(2013-03-01) Riegel, Barbara; Dickson, Victoria V; Topaz, MaximBackground: Self-care of heart failure has been described as a naturalistic decision-making process, but the data available to defend this description are anecdotal. Objectives: The aim of this study was to explore the process used by adults with chronic heart failure to make decisions about their symptoms. Methods: This was a secondary analysis of data obtained from four mixed methods studies. The full data set held qualitative data on 120 adults over the age of 18 years. For this analysis, maximum variation sampling was used to purposively select a subset of 36 of the qualitative interviews to reanalyze. Results: In this sample, equally distributed by gender, 56% Caucasian, between 40 and 98 years, the overarching theme was that decisions about self-care reflect a naturalistic decision-making process with components of situation awareness with mental simulation of a plausible course of action and an evaluation of the outcome of the action. In addition to situation awareness and mental simulation, three key factors were identified as influencing self-care decision making: (a) experience; (b) decision characteristics such as uncertainty, ambiguity, high stakes, urgency, illness, and involvement of others in the decision-making process; and (c) personal goals. Discussion: These results support naturalistic decision making as the process used by this sample of adults with heart failure to make decisions about self-care. PublicationPalliative Care: Is Now the Time?(2018-01-02) Riegel, Barbara; Kimmel, Stephen EPalliative care is an approach that focuses on optimizing quality of life for patients and families affected by serious illness, regardless of prognosis. It comprises pain and symptom management; psychological, spiritual, and social support; assistance with treatment decision-making; and complex care coordination. Mounting evidence indicates that palliative care reduces symptom burden, improves mood, decreases healthcare utilization, and improves quality of life for both patients with end-stage heart disease and their caregivers. Indeed, there is a consensus among major clinical guidelines of the importance of early integration of palliative care as an essential component of high quality care for patients with heart failure, a growing use of palliative care in patients with end-stage heart disease, and a clear desire of patients for such care. PublicationDesign and Rationale of Safe Pediatric Euglycemia After Cardiac Surgery (SPECS): A Randomized Controlled Trial of Tight Glycemic Control After Pediatric Cardiac Surgery(2013-02-01) Gaies, Michael G; Langer, Monica; Alexander, Jamin; Steil, Garry M; Ware, Janice; Wypij, David; Laussen, Peter C; Newburger, Jane W; Goldberg, Caren S; Pigula, Frank A; Shukla, Avinash C; Duggan, Christopher P; Agus, Michael S D; Curley, Martha A. Q.Objectives: To describe the design of a clinical trial testing the hypothesis that children randomized to tight glycemic control with intensive insulin therapy after cardiac surgery will have improved clinical outcomes compared to children randomized to conventional blood glucose management. Design: Two-center, randomized controlled trial. Setting: Cardiac ICUs at two large academic pediatric centers. Patients: Children from birth to those aged 36 months recovering in the cardiac ICU after surgery with cardiopulmonary bypass. Interventions: Subjects in the tight glycemic control (intervention) group receive an intravenous insulin infusion titrated to achieve normoglycemia (target blood glucose range of 80–110 mg/dL; 4.4–6.1 mmol/L). The intervention begins at admission to the cardiac ICU from the operating room and terminates when the patient is ready for discharge from the ICU. Continuous glucose monitoring is performed during insulin infusion to minimize the risks of hypoglycemia. The standard care group has no target blood glucose range. Measurements and Main Results: The primary outcome is the development of any nosocomial infection (bloodstream, urinary tract, and surgical site infection or nosocomial pneumonia). Secondary outcomes include mortality, measures of cardiorespiratory function and recovery, laboratory indices of nutritional balance, immunologic, endocrinologic, and neurologic function, cardiac ICU and hospital length of stay, and neurodevelopmental outcome at 1 and 3 yrs of age. A total of 980 subjects will be enrolled (490 in each treatment arm) for sufficient power to show a 50% reduction in the prevalence of the primary outcome. Conclusions: Pediatric cardiac surgery patients may recognize great benefit from tight glycemic control in the postoperative period, particularly with regard to reduction of nosocomial infections. The Safe Pediatric Euglycemia after Cardiac Surgery trial is designed to provide an unbiased answer to the question of whether this therapy is indeed beneficial and to define the associated risks of therapy. PublicationUsing Growth Mixture Modeling to Identify Classes of Sodium Adherence in Adults with Heart Failure(2014-05-01) Masterson-Creber, Ruth; Lee, Christopher S; Lennie, Terry A; Topaz, Maxim; Riegel, BarbaraBACKGROUND: The prevention of fluid retention is important to reduce hospitalizations in patients with heart failure (HF). Following a low-sodium diet helps to reduce fluid retention. OBJECTIVE: The primary objective of this study was to use growth mixture modeling to identify distinct classes of sodium adherence-characterized by shared growth trajectories of objectively measured dietary sodium. The secondary objective was to identify patient-level determinants of the nonadherent trajectory. METHODS: This was a secondary analysis of data collected from a prospective longitudinal study of 279 community-dwelling adults with previously or currently symptomatic HF. Growth mixture modeling was used to identify distinct trajectories of change in 24-hour urinary sodium excretion measured at 3 time points over 6 months. Logistic modeling was used to predict membership in observed trajectories. RESULTS: The sample was predominantly male (64%), had a mean age of 62 years, was functionally compromised (59% New York Heart Association class III), and had nonischemic HF etiology. Two distinct trajectories of sodium intake were identified and labeled adherent (66%) and nonadherent (34%) to low-sodium diet recommendations. Three predictors of the nonadherent trajectory were identified, confirming our previous mixed-effect analysis. Compared with being normal weight (body mass index/m2), being overweight and obese was associated with a 4-fold incremental increase in the likelihood of being in the nonadherent trajectory (odds ratio [OR], 4.63; 95% confidence interval [CI], 1.66-12.91; P < .002). Being younger than 65 years (OR, 4.66; 95% CI, 1.04-20.81; P = .044) or having diabetes (OR, 4.15; 95% CI, 1.29-13.40; P = .016) were both associated with more than 4 times the odds of being in the nonadherent urine sodium trajectory compared with being older than 65 years or not having diabetes, respectively. CONCLUSIONS: Two distinct trajectories of sodium intake were identified in patients with HF. The nonadherent trajectory was characterized by an elevated pattern of dietary sodium intake shown by others to be associated with adverse outcomes in HF. Predictors of the nonadherent trajectory included higher body mass index, younger age, and diabetes.