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• Development of DNP Project ethical review process expedited QI determination. • Ethical review process provides scholarly and ethical determination that aligns with the IRB. • Review process protects participants, supports students, and empowers faculty. • Ethical review combines project management, understanding QI VS. HSR, and expert consensus. • Rationale and process for creating and implementing an ethical review committee. DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR). Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions. Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created. 100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks. This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency. [ABSTRACT FROM AUTHOR]

Background: In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice.Methods: PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting.Results: Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006).Conclusions: In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice. [ABSTRACT FROM AUTHOR]

Context: Stability of preferences for life-sustaining treatment may vary depending on personal characteristics.Objective: We estimated the stability of preferences for end-of-life treatment over 12 years and whether advance directives and medical conditions were associated with change in preferences for end-of-life treatment.Design: Mailed survey of older physicians.Methods: Longitudinal cohort study of medical students in the graduating classes from 1948 to 1964 at Johns Hopkins University. Eight hundred ninety eight physicians who completed the life-sustaining treatment questionnaire anytime in 1999, 2002, 2005, and 2011 (mean age 68.2 years at baseline). Preferences for life-sustaining treatment were assessed using a checklist questionnaire in response to a standard "brain injury" scenario and considered as a package using the latent class transition model.Results: End-of-life preferences grouped into three classes: most aggressive (wanting most interventions; 14% of physicians), least aggressive (declining most interventions; 61%), and an intermediate class (declining most interventions except intravenous fluids and antibiotics; 25%). Physicians without an advance directive were more likely to desire more treatment and were less likely to transition out the most aggressive class. Transition probabilities from class to class did not vary over time. Persons with cancer expressed preference for the least aggressive treatment, whereas persons with cardiovascular disease and depression had preferences for more aggressive treatment.Conclusion: Transitions in end-of-life preferences and the factors influencing change and stability suggest that periodic reassessment for planning end-of-life care is needed. [ABSTRACT FROM AUTHOR]

Abstract Background Left ventricular assist devices (LVADs) improve quality of life in end-stage heart failure but can cause serious complications such as infections with driveline infection causing significant morbidity and mortality. Objectives The purpose of this systematic literature review is to synthesize the literature to determine variables associated with driveline infection and seek opportunities to improve nursing management of LVAD drivelines. Methods A systematic literature review was performed. The evidence was synthesized using the Johns Hopkins Nursing Evidence-Based Practice tools and the Chain of Infection epidemiological framework. Results Thirty-four studies focused on vulnerable host, portal of entry, and causative organism aspects of the Chain of Infection. Increased BMI, younger age, exposed driveline velour showed increased risk of infection and driveline dressing protocol change showed lower risk of infection. Conclusions Although some risk factors for infection were identified, evidence is still limited. Nurses are uniquely positioned to improve driveline management, disrupting the chain of infection. [ABSTRACT FROM AUTHOR]

Patients with HF often experience fragmented care, severe physical and psychological symptoms, existential distress, increased caregiving needs, and complex end of life decisions. Palliative care (PC) is well-suited to address these complex PC needs and improve quality of life (QOL), especially for physically frail people at risk for poor outcomes. The purpose of this study was to examine unmet PC needs and their associations with health related QOL in physically frail persons with HF. We recruited a convenience sample of persons with HF from an urban hospital system who were: ≥ 50 years old and had hospitalization in the last year. We excluded patients who had moderate/severe cognitive impairment, were enrolled in hospice or were non-English speaking. We measured frailty using the FRAIL scale (0-5: 0 = robust, 1-2 = pre-frail, 3-5 = frail), PC needs using the Integrated Palliative Outcome Scale (score 0-68; higher score = higher PC needs), and health related QOL using the Kansas City Cardiomyopathy Questionnaire (0-100; higher scores = better QOL). We performed multiple linear regression to test the relationships between physical frailty, PC needs, and QOL and a subgroup analysis of four PC needs/frailty groups (high PC needs/frail, high PC needs/robust, low PC needs/frail, low PC needs/robust). We enrolled 320 people, 292 completed surveys. Mean age was 68 (SD 9.8), 37% were female (n=108), 28% identified as Black/African American (n=83), and 33% reported financial strain (n=96). Participants averaged 2 hospitalizations in the last year. Only 5% of participants had a documented PC consultation at any point during their illness trajectory. Most participants were physically frail (44%, n=127) or pre-frail (41%, n=120). Mean PC needs score was 19.7 and frail participants had a significantly higher mean PC needs score than pre-frail or robust participants. Mean QOL score was 59.8 (range 17.5 to 91.7). For each 1 unit increase in palliative care needs, quality of life decreased by 1.12 units (p<0.001), adjusting for covariates (age, comorbidities, financial strain, education, race, gender, ejection fraction, and employment). Compared to robust participants, physically frail participants (beta= -28.8, p<0.001) and pre-frail participants (beta = -11.7, p<0.001) had significantly lower quality of life scores. In a subgroup analysis of 4 frailty/PC needs groups, physically frail participants with high PC needs had the lowest quality of life score (beta = -28.6, p<0.001). Physically frail and pre-frail people with HF have higher unmet PC needs and lower QOL than robust people with HF. Physical frailty and PC needs screening in clinical settings may improve identification of patients at risk for poor QOL amenable to PC intervention. [ABSTRACT FROM AUTHOR]

Objective To synthesize information supporting coping and adaptation of LVAD patients and to identify opportunities for future interventions. Background Left Ventricular Assist Device (LVAD) patients demonstrate improvements in quality of life and functional status, but qualitative research has not been meaningfully integrated. Methods Qualitative meta-synthesis using Lazarus and Folkmans' Transactional Model of stress and coping. Results Four distinct stages of adaptation were identified: Pre-LVAD, Implant Hospitalization, Early Home Adaptation and Late Home Adaptation. Each stage includes tasks in physical, psychological and social domains. Two themes emerged: 1) Primary Appraisal: Every stage is a new challenge and 2) Secondary Appraisal: Routines are achievable, emotions are more difficult. Conclusions Emotional challenges including fear and anxiety related to life-limiting illness and changed social roles need to be honestly addressed. Individuals living with LVAD achieve a sense of independence, enjoy social interactions and meaningful activities through addressing practical and emotional problems to facilitate coping. [ABSTRACT FROM AUTHOR]

Background: Heart failure (HF) is a major health care burden and there is a growing need to develop strategies to maintain health and sustain quality of life in persons with HF. The purpose of this review is to critically appraise the components of nutrition interventions and to establish an evidence base for future advances in HF nutrition research and practice.Methods and Results: Cinahl, Pubmed, and Embase were searched to identify articles published from 2005 to 2015. A total of 17 randomized controlled trials were included in this review. Results were divided into 2 categories of nutrition-related interventions: (1) educational and (2) prescriptive. Educational interventions improved patient outcomes such as adherence to dietary restriction in urine sodium levels and self-reported diet recall. Educational and prescriptive interventions resulted in decreased readmission rates and patient deterioration. Adherence measurement was subjective in many studies. Evidence showed that a normal-sodium diet and 1-liter fluid restriction along with high diuretic dosing enhanced B-type natriuretic peptide, aldosterone, tumor necrosis factor α, and interleukin-6 markers.Conclusions: Educational nutrition interventions positively affect patient clinical outcomes. Although clinical practice guidelines support a low-sodium diet and fluid restriction, research findings have revealed that a low-sodium diet may be harmful. Future research should examine the role of macronutrients, food quality, and energy balance in HF nutrition. [ABSTRACT FROM AUTHOR]

The prevalence of advanced heart failure (HF) is increasing because of the aging population and improvements in HF management strategies. Left ventricular assist device (LVAD) technology and management continue to advance rapidly, and it is anticipated that the number of LVAD implants will increase. LVADs have been demonstrated to extend life and improve outcomes in patients with advanced HF. The purpose of this article is to review and synthesize the evidence on impact of LVAD therapy on functional status. Significant functional gains were demonstrated in patients supported by LVAD throughout the 1st year, with most improvement in distance walked and peak oxygen consumption demonstrated in the 1st 6 months. Interventions to enhance exercise performance have had inconsistent effects on functional status. Poor exercise performance was associated with increased risk of adverse events. Functional status improved with LVAD therapy, although performance remained substantially reduced compared with age-adjusted norms. There is tremendous need to enhance our understanding of factors influencing functional outcomes in this high-risk population. [ABSTRACT FROM AUTHOR]

Few reliable, non-invasive clinical markers have been identified for evaluating readiness for discharge in patients with heart failure. Worsening sleep orthopnea, including the use of additional pillows, has long been considered a sign of worsening heart failure symptoms, however in the hospital the adjusted angle of the bed could be another way to assess sleep orthopnea. This study examined variation in the angle of the bed, whether the angle of bed the night prior to discharge could be useful as a non-invasive clinical indicator and whether there is a relationship between the angle of bed while patients are sleeping the night prior to discharge and 30-day readmission. It was hypothesized that the angle of the head of bed the night prior to discharge from the index admission would be higher in patients who are readmitted within 30 days of discharge. In addition, it was hypothesized that the correlation between angle of bed and amount of diuresis would allow for use of angle of bed as a clinical indicator. In this prospective observational study, nurses measured the angle at which patients self-adjusted the bed for nighttime sleeping. Patients from a progressive cardiac care unit were included if the primary admitting diagnosis was volume overload related to heart failure. Patients (n = 145) were 46.2% female, 46.2% African American with a mean age of 63.4 ± 14.7 years. Mean length of stay was 12.5 ± 10.5 days, and 22.8% were readmitted within 30 days. The average angle of bed prior to discharge was 29.1 ± 18.7 degrees and only 13% were able to lay flat while sleeping on the night prior to discharge. There was a significant difference between the highest and lowest angle of HOB (p<0.001), however for 37% of the patients their highest HOB angle was after their lowest HOB angle, implying worse orthopnea closer to discharge. Angle of bed was not associated with 30-day readmission (p=0.19) and there were no other demographic or clinical characteristics associated with angle of bed. We did not demonstrate the utility of angle of bed the night prior to discharge as a marker of readiness for discharge in patients with heart failure. However, this innovative, nurse-led project did demonstrate that angle of bed is non-invasive and easy to capture. Further studies should consider the role of angle of bed as an indication of orthopnea and in evaluating readiness for discharge during a heart failure admission. [ABSTRACT FROM AUTHOR]

Background There is no empirical study about the context and influence of self-management (SM) factors on quality of life (QOL) among adults with left ventricular assist device (LVADs). The purpose of this study was to close this knowledge gap by: (1) differentiating select SM factors (e.g., cognition) and overall QOL based on LVAD implant durations; (2) examining the relationships among SM factors and QOL variables; and (3) identifying which SM factors predict QOL. Methods An observational study was employed including 87 LVAD patients, ages 20 to 80 years, with mean implant durations of 18.5 ± 15.1 months. Patients completed 1 demographic questionnaire and 6 measures of SM factors (cognition—general and executive function, LVAD self-efficacy, care dependency and adherence) and QOL. Data were analyzed with descriptive and inferential statistical procedures. Results There was no significant difference in SM factors and overall QOL by LVAD implant durations. SM factors, including cognitive function, LVAD self-efficacy, and adherence, correlated positively with QOL ( r = 0.35 to 0.48, p < 0.05), but LVAD care dependency correlated negatively with QOL ( r = −0.21, p < 0.05). The general and executive function of cognition and LVAD adherence were significant predictors of QOL. Conclusions The data inferred that higher level of cognitive function is associated with higher self-efficacy, adherence and greater QOL, whereas lower care dependency is associated with greater QOL. Higher cognitive function and adherence to the LVAD care regimen predicted better QOL outcome. Further research is needed to elucidate the mechanism by which SM factors influence QOL in adults with long-term LVADs. [ABSTRACT FROM AUTHOR]

• This is the first study to describe haploidentical child donor perspectives. • Despite relational strains, family functioning rarely affected decisions to donate. • Participants felt satisfied by decision and ability to give back to their parent. • Additional educational/emotional support is needed to improve donor experiences. Increasingly, adolescent, young adult, and adult children are relied upon as donors for their parents undergoing blood and marrow stem cell transplant. How family functioning impacts donors' decision making and whether haploidentical donor children have unique supportive care needs is unknown. In this qualitative research study, we conducted 15 semistructured telephone interviews among individuals who underwent blood or marrow stem cell donation for their parent. Interviews explored donors' perspectives of the transplant experience across the trajectory from screening through early post-transplant follow-up and elicited unmet needs. Major themes included: (1) perception of choice, (2) act of giving back, (3) burdens of donation, (4) anticipated health benefit to parent, and (5) impact of donation on parent/child relationship. The majority of participants described high family functioning, but strain was also evident. Family functioning rarely was reported as affecting the decision to donate, with all donors expressing a sense of obligation. Participants were overwhelmingly satisfied with their decision and the ability to give back to their parent. Suggestions for the health care team to improve the donation experience focused on increased education about potential delays in screening, better description of possible complications for recipients, and provision of emotional support following donation. [ABSTRACT FROM AUTHOR]

BACKGROUND Trial and registry data have reported mortality rates and causes of death in patients with left ventricular assist devices (LVADs); however, a more granular description is needed of end of life, including location of death and quality of life (QOL), to better guide expectations and care. METHODS To identify where patients with an LVAD died, characterize QOL before death, and cause of death over time, we evaluated patients in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) implanted with a continuous-flow LVAD. RESULTS From 18,733 patients implanted with an LVAD during the period 2008 to 2016, 4,916 patients were known to have died, of whom 98% had a recorded location of death. Overall, 76.9% died in the hospital, with progressively more patients dying outside of the hospital further post-LVAD implant: <1 month, 2.3%; 1 to 12 months, and 16.8%; and >12 months, 37.4%. In a multivariable analysis, increased age (RR (risk ratio) 1.06, 95% confidence interval [CI] 1.02 to 1.12, p = 0.01) and destination therapy indication (RR 1.15, 95% CI 1.03 to 1.28, p = 0.01) increased the likelihood of dying outside the hospital. Comparing 3 months post-implant with 6 months before death in a subset of patients, QOL remained clinically stable (EQ-5D Visual Analog Scale [mean ± SD]: 68.3 ± 22.2 to 66.7 ± 21.7, p = 0.11; KCCQ: 61.0 ± 22.2 to 57.8 ± 23.2, p = 0.003). The most common cause of death <1 month post-implant was multiple-organ failure (20.4%) and at >1 month post-implant it was neurologic dysfunction (28.2%). CONCLUSIONS Most patients with an LVAD died in the hospital. QOL remained stable months before death and causes of death were varied, but increasingly dominated by stroke. By understanding death with an LVAD in place, clinicians are in a better position to educate patients and caregivers about what to expect and provide to support tailored to patient and caregiver needs. [ABSTRACT FROM AUTHOR]

Greater family caregiver exposure to uncontrolled patient symptoms is predictive of greater caregiver psychological and physiological stress in dementia and other chronic illnesses, but these phenomena have not been well-studied in heart failure (HF) – a disease with high symptom burden. The purpose of this study was to test the hypothesis that worse patient functional status (as reflected by increasing HF symptoms) would be associated with elevated psychological and physiological stress for the caregiver. This was a secondary analysis of data from 125 HF caregivers in the Caregiver Opportunities for Optimizing Lifestyle (COOL) study. Psychological stress was measured on four dimensions: care-related strain/burden (Oberst Caregiving Burden Scale), depression (Center for Epidemiological Studies Depression Scale), anxiety (State-Trait Anxiety Index), and general stress (Perceived Stress Scale). Physiological stress was measured by markers of HPA axis function (elevated cortisol awakening response [CAR]), endothelial dysfunction (increased PAI-1), and inflammation (increased IL-6, hsCRP). HF patient functional status was quantified by caregiver assessment of New York Heart Association (NYHA) Class. Generalized linear models were used to test associations between patient NYHA Class and stress (one model per indicator). NYHA Class (ordinal) was backwards difference coded in each model to examine caregiver stress in relation to increasing levels of HF severity. Caregivers were mostly female and in their mid-fifties, with a slight majority of the sample being African American and the patient's spouse. Overall, patient functional status was associated with greater caregiver psychological and physiological stress. In terms of psychological stress, higher NYHA Class was significantly associated with greater caregiver anxiety and general stress, but not with caregiver burden or depression. In terms of physiological stress, higher NYHA Class was associated with elevated markers in all models (elevated CAR and higher IL-6, hsCRP, and PAI-1). Across models, most associations between NYHA Class and stress were present at relatively early stages of functional limitation (i.e. Class II), while others emerged when functional limitations became more severe. To inform timing and mechanisms for much-needed caregiver interventions, research is needed to determine which aspects of HF symptomatology are most stressful for caregivers across the HF trajectory. • Caregiving for a family member with heart failure is a major stressor. • Worsening heart failure linked to caregiver anxiety and general stress. • Worsening heart failure linked to elevated markers of caregiver inflammation. • Worsening heart failure also linked to elevated cortisol, endothelial dysfunction. [ABSTRACT FROM AUTHOR]