Caregivers of Patients With Left Ventricular Assist Devices: Possible Impacts on Patients' Mortality and Interagency Registry for Mechanically Assisted Circulatory Support-Defined Morbidity Events.

BACKGROUND: How caregivers contribute to positive or negative outcomes for left ventricular assist device (LVAD) patients remains unclear. Our primary study objectives were to (1) identify caregiver support attributes through a retrospective chart review of social workers' psychosocial assessments for LVAD patients and (2) determine how these attributes associated with patients' post-LVAD placement mortality and Interagency Registry for Mechanically Assisted Circulatory Support-defined morbidity events. METHODS AND RESULTS: We retrospectively reviewed and recorded social workers' clinical assessments of adult patients implanted with durable continuous-flow LVADs as bridge to transplant, destination therapy, or bridge to decision from January 2010 to December 2014. Associations between caregiver characteristics and patient mortality and morbidity events were analyzed using Kaplan-Meier curves and Cox proportional hazards regression. Patient follow-up time was calculated as the time from hospital discharge until the earliest among death with LVAD, transplant, or the last day of the study (December 31, 2015). Patients were censored for death with LVAD at the time of transplant or the last day of the study. A total of 96 LVAD recipients were included in this study. Having a caregiver who understands the severity of the illness and options available to the patient (as determined and documented by the social worker; P=0.01), a caregiver who has identified a backup plan (P=0.02), and a caregiver who is able to provide logistical support (P=0.04) significantly mitigated risk of death. The risk of death for an LVAD patient was also significantly lower among those who have at least 1 adult child who lives within 50 miles (P=0.03) and those who have an extended family who can care for the patient (P=0.03). The risk of death was 3.1× more likely among patients who live alone compared with those who do not live alone (P=0.04). No caregiver characteristics were significantly associated with morbidity. CONCLUSIONS: This exploratory, hypothesis-generating study suggests that mortality after LVAD placement is impacted by caregiver understanding of patient severity of illness and caregiver presence. This study provides initial evidence to support further work in understanding the associations between caregivers and LVAD patients, as well as interventions that may improve patient outcomes. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02248974.

Development and validation of a patient-centered knowledge scale for left ventricular assist device placement.

BACKGROUND: A central tenet of patient-centered health care advocated by the Institute of Medicine and the American Medical Association is to enhance informed decision-making in a way that incorporates patient values, knowledge and beliefs. Achievement of this goal is constrained by a lack of validated measures of patients' knowledge needs. METHODS: In this study we present a comprehensive and valid methodology for developing a clinically informed and patient-centered measure of knowledge about left ventricular assist device (LVAD) therapy to facilitate discussion and measure candidate understanding of treatment options. Using structured interviews with patients, caregivers, candidates for LVAD treatment (New York Heart Association Class III and IV) and expert clinicians (n = 71), we identified top patient decisional needs and perspectives on essential knowledge needs for informed decision-making. From this list, we generated 20 knowledge scale question items to refine in cognitive interviews (n = 5) with patients and patient consultants. RESULTS: Good internal consistency and reliability of the knowledge scale (Cronbach's α = 0.81) was seen in 30 LVAD patients and candidates. Knowledge was higher among patients currently with LVADs than candidates, regardless of receiving standard education (with education: 69.9 vs 50.1, adjusted p = 0.02; without education: 69.9 vs 37.6, adjusted p < 0.001). CONCLUSION: The LVAD knowledge scale may be useful in clinical settings to identify gaps in knowledge among patient candidates considering LVAD treatment, and to better tailor education and discussion with patients and their caregivers, and to enhance informed decision-making before treatment decisions are made.

Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: Implications for informed consent and shared decision-making.

BACKGROUND: Several organizations have underscored the crucial need for patient-centered decision tools to enhance shared decision-making in advanced heart failure. The purpose of this study was to investigate the decision-making process and informational and decisional needs of patients and their caregivers regarding left ventricular assist device (LVAD) placement. METHODS: In-depth, structured interviews with LVAD patients, candidates and caregivers (spouse, family members) (n = 45) were conducted. We also administered a Decisional Regret Scale. RESULTS: Participants reported LVAD decision-making to be quick and reflexive (n = 30), and deferred heavily to clinicians (n = 22). They did not perceive themselves as having a real choice (n = 28). The 2 most prevalent informational domains that participants identified were lifestyle issues (23 items), followed by technical (drive-line, battery) issues (14 items). Participants easily and clearly identified their values: life extension; family; and mobility. Participants reported the need to meet other patients and caregivers before device placement (n = 31), and to have an involved caregiver (n = 28) to synthesize information. Some participants demonstrated a lack of clarity regarding transplant probability: 9 of 15 patients described themselves as on a transplant trajectory, yet 7 of these were destination therapy patients. Finally, we found that decisional regret scores were low (1.307). CONCLUSIONS: Informed consent and shared-decision making should: (a) help patients offered highly invasive technologies for life-threatening disease get past the initial "anything to avoid thinking about death" reaction and make a more informed decision; (b) clarify transplant status; and (c) focus on lifestyle and technical issues, as patients have the most informational needs in these domains.