Abstract 219: Health Literacy and Numeracy in Patients Considering a Left Ventricular Assist Device: Findings From the DECIDE-LVAD Trial

Author(s):  
David S Raymer ◽  
Larry A Allen ◽  
Daniel D Matlock ◽  
Colleen K McIlvennan ◽  
Jocelyn S Thompson ◽  
...  

Introduction: The DECIDE-LVAD Trial demonstrated the benefit of a decision support tool for patients considering destination-therapy left ventricular assist device (DT LVAD) implantation. We hypothesized that patients with low health literacy or numeracy may have benefited most from the intervention. Methods: We used the Rapid Estimate of Adult Literacy in Medicine (REALM-R) and the Subjective Numeracy Scale (SNS) to assess patients’ health literacy and numeracy, respectively. A REALM-R score of six or less out of eight identified patients at risk for poor literacy based on the original measure validation. An SNS score less than four out of six identified patients with poor subjective numeracy based on the mean score of the DECIDE-LVAD cohort. We assessed the effect of the decision support tool on LVAD knowledge and values-treatment concordance—concordance between patients’ stated values and their treatment outcome of LVAD or continued medical therapy—and their interaction with health literacy and numeracy. This interaction was assessed using linear mixed models for LVAD knowledge and the difference in Kendall’s tau correlation coefficient for values-treatment concordance. Results: Of the 248 DECIDE-LVAD patients, 228 with complete literacy and numeracy data were analyzed: 51% (116) had high literacy and numeracy; 18 (8%) had low literacy and high numeracy; 55 (25%) had high literacy and low numeracy; 39 (17%) had low scores for both measures. Average age was 63, 15% were female, 19% were racial/ethnic minorities. Patients with high scores for both measures were older, had more formal education, and higher total household income compared to the other 3 groups. Patients with low literacy and/or numeracy had significantly lower LVAD knowledge scores at baseline. In all groups, LVAD knowledge improved over time. The difference in LVAD knowledge between those with low literacy and high literacy decreased over time (baseline difference 9.4%, p=0.002; 6 month follow-up difference 1.4%, p=0.65). In those with high literacy, the decision support tool intervention increased the LVAD knowledge score by 4.2% relative to the control (p=0.15), while in those with low literacy, the intervention increased the score by 10.6% (p=0.04). For patients with low literacy, values-treatment concordance improved with use of the decision support tool (control vs. intervention tau: 0.234 vs 0.673, p=0.028). We did not observe differences in the effect of the intervention by participant numeracy score. Conclusion: All patient groups in the DECIDE-LVAD cohort of patients considering DT LVAD had improved LVAD knowledge with the use of the decision support tool. We did not observe a differential effect of the intervention by numeracy score. Compared to those with higher health literacy, patients with low health literacy improved their LVAD knowledge and values-treatment concordance after the intervention.

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Ovais Inamullah ◽  
Yuting Chiang ◽  
Martin Weiss ◽  
Michael Lutz ◽  
Carmelo Milano ◽  
...  

Introduction: Stroke is a devastating complication of left ventricular assist device (LVAD) therapy and a leading cause of mortality in this group. The newer HeartMate (HVAD, 2012) and HeartMate 3 (HM3, 2017) devices use a continuous flow centrifugal pump with a magnetically levitated rotor that may cause less thrombosis and stroke. We aim to compare the rate and severity of strokes in the setting of the new generation LVADs. Methods: This was a single-center retrospective cohort study at a single US academic medical center. The cohort includes all subjects at Duke University Medical Center who received either an HM3 or HVAD LVAD between September 2009 through February 2018 and had a cerebrovascular accident while the LVAD was in place. Descriptive statistics were calculated to compare the clinical variables for individuals receiving either the HVAD or HM3 device. 95% confidence intervals were calculated when appropriate. Results: A total of 163 HVAD patients and 84 HM3 patients were included in the analysis. Strokes occurred more commonly among those with HVAD (14.7%, 9.7%-21.1%) compared to those with HM3 (6.0%, 2.0%-13.3%). About 62.1% of strokes were ischemic. Patients with HM3 were older and had a higher rate of cardiovascular risk factors. The initial mean NIHSS was higher in HM3 patients (24.6, 11.9-37.3) compared to those with HVADs (16, 10.9-21.1). Mortality within 30 days was higher in HM3 patients (60.0%, 14.7%-94.7%) compared to HVAD patients (45.8%, 25.6%-67.2%). Patients were more likely to be disabled (mRs> 3) at 3 months if they had an HM3 (80%, 28.4%-99.5%) compared to those who had an HVAD (54.2%, 32.8%-74.4%). Conclusion: Strokes occurred more commonly among those with HVAD compared to HM3, but the strokes in those with HM3 tended to be more severe at onset compared to HVAD with a higher 30 days mortality and more disability at 3 months. The difference in stroke frequency may suggest that the HM3 is less prone to thrombosis. The difference in mortality may have been secondary to patients with HM3 being older and with more cardiovascular risk factors or could be related to a reduction in minor strokes causing a shift to worse outcomes. Additional studies are needed to understand the predictors of stroke in the setting of the new generation LVADs.


2021 ◽  
Author(s):  
Clarissa Judith Gardner ◽  
Jack Halligan ◽  
Gianluca Fontana ◽  
Roberto Fernandez Crespo ◽  
Matthew Stewart Prime ◽  
...  

Simulation-based research (SBR) methods have been proposed as an alternative methodology for evaluating digital health solutions; however, applicability remains to be established. This study used SBR to evaluate a clinical decision support (CDS) tool used for matching cancer patients to clinical trials. 25 clinicians and research staff were recruited to match 10 synthetic patient cases to clinical trials using both the CDS tool and publicly available online trial databases. Participants were significantly more likely to report having sufficient time (p = 0.020) and to require less mental effort (p = 0.001) to complete trial matching with the CDS tool. Participants required less time for trial matching using the CDS tool, but the difference was not significant (p = 0.093). Most participants reported that they had sufficient guidance to participate in the simulations (96%). This study demonstrates the use of SBR methods is a feasible approach to evaluating digital health solutions.


Author(s):  
Colleen K McIlvennan ◽  
Madhav Narayan ◽  
Anne Cannon ◽  
William J Bradley ◽  
Carolyn Nowels ◽  
...  

Background: Patients offered left ventricular assist device as destination therapy (DT LVAD) are typically faced with the decision to undergo major surgery and live their remaining life dependent on mechanical circulatory support (MCS) or transition to end-of-life care. MCS coordinators are often the first point of contact and provide education and support to patients making this difficult decision. Methods: We conducted semi-structured, in-depth interviews with MCS coordinators in order to characterize the range of decision support and preparation offered to patients considering DT LVAD and to solicit input on how to optimize that process. Interviews took place from August 2012 to January 2013. All interviews were digitally recorded and data were analyzed using a directed content analysis approach. Results: Our sample included 20 MCS coordinators from different programs around the United States. The following primary themes emerged: 1) cardiothoracic surgeons or heart failure cardiologists were primarily responsible for presenting risks and benefits of DT LVAD whereas coordinators provided the majority of patient education regarding practical concerns and patient/caregiver responsibilities; 2) existing consents and industry material are too complicated or overly optimistic; 3) tension exists between creating accurate expectations of DT LVADs and providing clinical reassurance - “I don’t want to scare them away from a life-saving therapy either, so I try to paint a realistic picture but not so realistic that it scares them;” and 4) when asked to theoretically consider if they were offered DT LVAD, the majority of coordinators stated that it would be a difficult decision influenced by their own age, co-morbidities, and family dynamics - “I think it would really depend on where I was in my life at that point in time.” Conclusions: MCS coordinators are in a unique position to assist in decision making and preparation for patients eligible for DT LVADs. In order to improve this process, a multidisciplinary and iterative approach appears helpful in conveying the risks and benefits of DT LVAD. Consents and educational materials must be simplified, patient-centered, and free of bias. Patient needs and values should be defined up front to help tailor the process. The uncertainty of many MCS coordinators, who arguably best understand the totality of therapy, to theoretically pursue DT LVAD themselves highlights the difficult trade-offs and personalized nature of this decision.


Author(s):  
J P Cassella ◽  
V Salih ◽  
T R Graham

Left ventricular assist systems are being developed for eventual long term or permanent implantation as an alternative to heart transplantation in patients unsuitable for or denied the transplant option. Evaluation of the effects of these devices upon normal physiology is required. A preliminary study was conducted to evaluate the morphology of aortic tissue from calves implanted with a pneumatic Left Ventricular Assist device-LVAD. Two 3 month old heifer calves (calf 1 and calf 2) were electively explanted after 128 days and 47 days respectively. Descending thoracic aortic tissue from both animals was removed immediately post mortem and placed into karnovsky’s fixative. The tissue was subsequently processed for transmission electron microscopy (TEM). Some aortic tissue was fixed in neutral buffered formalin and processed for routine light microscopy.


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