ENABLE-LVAD: Development and Implementation of a Novel Training Program for Clinicians Supporting Family Caregivers of Patients With a Left Ventricular Assist Device.

BACKGROUND: Despite significant family caregiver (FCG) burnout, there are currently no tested interventions to support the FCG role after left ventricular assist device (LVAD) implantation or formalized training for clinicians to support FCGs. OBJECTIVE: We adapted the existing ENABLE (Educate, Nurture, Advise Before Life Ends) intervention to LVAD clinicians and FCGs and assessed clinical implementation and dissemination. METHODS: ENABLE-LVAD is an interactive, self-paced clinician training coupled with FCG-facing guidebooks and resources. Implementation and dissemination were evaluated by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. RESULTS: As of May 2023, 187 clinicians registered for the training, and 41 completed all modules (22.0% completion rate). Of those who completed the training and responded to a 6-month survey, one-third (n = 10, 33.3%) used ENABLE-LVAD with FCGs, and 100% of those planned to continue using it. The primary barrier to completing the training was time. CONCLUSIONS: The ENABLE-LVAD clinician training was successfully disseminated and implemented as a useful resource to support LVAD FCGs.

An Electronically Delivered Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure With Reduced Ejection Fraction: The EPIC-HF Trial.

BACKGROUND: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction. Without novel approaches to improve prescribing, the cumulative benefits of heart failure with reduced ejection fraction treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. METHODS: The EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction) trial randomized patients with heart failure with reduced ejection fraction from a diverse health system to usual care versus patient activation tools-a 3-minute video and 1-page checklist-delivered electronically 1 week before, 3 days before, and 24 hours before a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in heart failure with reduced ejection fraction prescribing. The primary endpoint was the percentage of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days after, compared with usual care during the same period. RESULTS: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient activation tools and 145 were controls. The median age of patients was 65 years; 29% were female, 11% were Black, 7% were Hispanic, and the median ejection fraction was 32%. Preclinic data revealed significant GDMT opportunities, with no patients on target doses of ß-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days after, 49.0% in the intervention and 29.7% in the control experienced an initiation or intensification of their GDMT (P=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths and no significant differences in hospitalization or emergency department visits at 30 days between groups. CONCLUSIONS: A patient activation tool delivered electronically before a cardiology clinic visit improved clinician intensification of GDMT. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03334188.

Health Literacy in Patients Considering a Left Ventricular Assist Device: Findings From the DECIDE-LVAD Trial.

OBJECTIVE: To assess the interaction of health literacy and a shared intervention concerning decision quality in patients considering the destination therapy of left ventricular assist device (DT LVAD) implantation. BACKGROUND: Evidence is limited for the use of decision aids by patients with low health literacy and with life-threatening illnesses. METHODS: We performed a secondary analysis of the DECIDE-LVAD Trial, a randomized, stepped-wedge trial conducted from 2015-2017 in the United States. The intervention was the integration of a formal shared decision-making intervention. The main outcome was decision quality as measured by LVAD knowledge and values-treatment concordance. Two components of health literacy were measured by the Rapid Estimate of Adult Literacy in Medicine and Subjective Numeracy Scale instruments. RESULTS: Of the 228 patients studied, 44% (n = 101) received the formal shared decision-making intervention, and half had low health literacy. Knowledge of LVAD improved for patients with low literacy in the intervention group compared to the control group: the difference in increased knowledge score was 10.6%; P = 0.04. Values-treatment concordance improved significantly for patients with low literacy in the intervention group compared to the control group: the median improvement in values-treatment correlation coefficient was 0.43; P = 0.03. These benefits were not significant in those with adequate literacy (n = 171). Patients with low numeracy (n = 94) did not show significant improvements in either measure of decision quality, and patients with adequate numeracy (n = 134) showed improvement in LVAD knowledge but not in values-treatment concordance. CONCLUSIONS: Patients considering DT LVAD implantation with low literacy showed improvement in decision quality after the integration of a shared decision-making intervention.

Social Determinants of Health and Rates of Implantation for Patients Considering Destination Therapy Left Ventricular Assist Device.

BACKGROUND: A left ventricular assist device (LVAD) is a treatment option available to select patients with advanced heart failure. However, there are important social determinants of health that can play a role in determining patients' outcomes after device placement. METHODS AND RESULTS: We leveraged the DECIDE-LVAD Trial to assess social determinants of health-relationship status, household income, race/ethnicity, educational attainment, and health insurance-at the time of evaluation, and their association with rate of LVAD placement in the subsequent year. About a quarter of patients were unpartnered (i.e., single/divorced/widowed/separated; n = 55 [26%]). A similar proportion had a household income of less than $20,000 per year (n = 50 [24%]). Few patients were other race (n = 39 [18%]), had less than a high school education (n = 14 [6.6%]), or had Medicaid as their primary payor (n = 17 [8.4%]). LVAD implantation was significantly lower among patients who were unpartnered compared with patients who were married or partnered. LVAD implantation was not associated with income, race, educational attainment or insurance status. CONCLUSIONS: Our data from diverse LVAD centers at U.S. private and academic hospitals found that, among a broad sample of patients being evaluated for LVAD, married or partnered status was favorably associated with LVAD implantation, but other social determinants of health were not. Future research and policy changes should consider novel interventions for improving access to LVAD implantation for patients with inadequate social support.

An Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction: Rationale and design of the EPIC-HF trial.

BACKGROUND: Heart failure with reduced ejection fraction (HFrEF) benefits from initiation and intensification of multiple pharmacotherapies. Unfortunately, there are major gaps in the routine use of these drugs. Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. HYPOTHESIS: Encouraging patients to engage providers in HFrEF prescribing decisions will improve the use of guideline-directed medical therapies. DESIGN: The Electronically delivered, Patient-activation tool for Intensification of Chronic medications for Heart Failure with reduced ejection fraction (EPIC-HF) trial randomizes patients with HFrEF to usual care versus patient-activation tools-a 3-minute video and 1-page checklist-delivered prior to cardiology clinic visits that encourage patients to work collaboratively with their clinicians to intensify HFrEF prescribing. The study assesses the effectiveness of the EPIC-HF intervention to improve guideline-directed medical therapy in the month after its delivery while using an implementation design to also understand the reach, adoption, implementation, and maintenance of this approach within the context of real-world care delivery. Study enrollment was completed in January 2020, with a total 305 patients. Baseline data revealed significant opportunities, with <1% of patients on optimal HFrEF medical therapy. SUMMARY: The EPIC-HF trial assesses the implementation, effectiveness, and safety of patient engagement in HFrEF prescribing decisions. If successful, the tool can be easily disseminated and may inform similar interventions for other chronic conditions.

Comorbidities and the decision to undergo or forego destination therapy left ventricular assist device implantation: An analysis from the Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study.

BACKGROUND: Patients considering destination therapy left ventricular assist devices (DT LVAD) often have high comorbid burden but the association between these comorbidities and post-decision outcomes is unknown. METHODS: We included subjects in DECIDE-LVAD (NCT02344576), a stepped-wedge multicenter trial of patients considering LVADs, recording comorbidities per INTERMACS protocol. We compared decisional conflict, regret, perceived stress, quality of life (EQ-VAS), depression (PHQ-2), struggle with- and acceptance of illness by comorbid burden and amongst the most common comorbidities. RESULTS: Of 239 patients, LVAD recipients (n = 164) and non-recipients (n = 75) had a similar proportion with ≥1 comorbidity (70% v. 80%, P = .09). Patients with comorbidities were younger regardless of LVAD implantation status. After adjusting for age, overall and amongst LVAD recipients, patients with ≥1 comorbidity had higher mean decision conflict at baseline (23.2 ±â€¯1.5 vs. 17.4 ±â€¯2.2), and at 6 months, higher stress (13.0 ±â€¯0.6 vs. 10.4 ±â€¯1.0) and struggle with illness (13.3 ±â€¯0.4 vs. 11.1 ±â€¯0.6) than those without comorbidities (P < .05). No difference was noted in decision regret, PHQ-2, EQ-VAS, acceptance of illness and survival overall and amongst LVAD recipients. Of the three most common comorbidities, while patients with pulmonary hypertension had worse decision regret, depression, stress and acceptance of illness at 6-month follow-up than those who did not have pulmonary hypertension, no difference was noted in patients with chronic renal disease or high body mass index. CONCLUSION: Patients considering LVAD implantation with comorbidities experience increased decision conflict, stress and struggle with illness. These findings provide insights in the role comorbidities play in patient decision-making and decisional outcomes.

Exploring cognitive bias in destination therapy left ventricular assist device decision making: A retrospective qualitative framework analysis.

BACKGROUND: Cognitive biases are psychological influences, which cause humans to make decisions, which do not seemingly maximize utility. For people with heart failure, the left ventricular assist device (LVAD) is a surgically implantable device with complex tradeoffs. As such, it represents an excellent model within which to explore cognitive bias in a real-world decision. We conducted a framework analysis to examine for evidence of cognitive bias among people deciding whether or not to get an LVAD. OBJECTIVES: The aim of this study was to explore the influence of cognitive bias on the LVAD decision-making process. METHODS: We analyzed previously conducted interviews of patients who had either accepted or declined an LVAD using a deductive, predetermined framework of cognitive biases. We coded and analyzed the interviews using an inductive-deductive framework approach, which also allowed for other themes to emerge. RESULTS: We interviewed a total of 22 heart failure patients who had gone through destination therapy LVAD decision making (15 who had accepted the LVAD and 7 who had declined). All patients appeared influenced by state dependence, where both groups described high current state of suffering, but the groups differed in whether they believed LVAD would relieve suffering or not. We found evidence of cognitive bias that appeared to influence decision making in both patient groups, but groups differed in terms of which cognitive biases were present. Among accepters, we found evidence of anchoring bias, availability bias, optimism bias, and affective forecasting. Among decliners, we found evidence of errors in affective forecasting. CONCLUSIONS: Medical decision making is often a complicated and multifaceted process that includes cognitive bias as well as other influences. It is important for clinicians to recognize that patients can be affected by cognitive bias, so they can better understand and improve the decision-making process to ensure that patients are fully informed.

Anchoring in Destination-Therapy Left Ventricular Assist Device Decision Making: A Mechanical Turk Survey.

BACKGROUND: People with end-stage heart failure may have to decide about destination-therapy left ventricular assist device (DT-LVAD). Individuals facing difficult decisions often rely on heuristics, such as anchoring, which predictably bias decision outcomes. We aimed to investigate whether showing a larger historical Heartmate XVE creates an anchoring effect, making the smaller Heartmate II (HMII) appear more favorable. METHODS: With the use of Amazon Mechanical Turk, participants watched videos asking them to imagine themselves dying of end-stage heart failure, then were presented the option of LVAD as potentially life-prolonging therapy. Participants were randomized to a control group who were only shown the HMII device, and the intervention group who saw the XVE device before the HMII. Participants then completed surveys. RESULTS: A total of 487 participants completed the survey (control = 252; intervention = 235); 79% were <40 years of age, 84% were white, and 55% were male. The intervention group was not more likely to accept the LVAD therapy (68% vs 61%; P = .37). However, participants in the intervention group were more likely (51% vs 17%; P < .01) to agree or strongly agree with the statement that the HMII was "smaller than expected." Participants in the intervention group were also more likely to rate the size of the device as "important" or "very important" in their decision (61% vs 46%; P < .01). CONCLUSIONS: Although the XVE anchor did not affect likelihood of accepting the LVAD, it did affect device perception. This article highlights an important point with clinical implications: factors such as anchoring have the potential to inappropriately influence perceptions and decisions and should be carefully considered in research and practice.

The Perceptions of Important Elements of Caregiving for a Left Ventricular Assist Device Patient: A Qualitative Meta-Synthesis.

BACKGROUND: The use of a left ventricular assist device (LVAD) is becoming increasingly common in patients with end-stage heart failure. Many LVAD programs require patients to have a caregiver before receiving a device. There are few studies exploring the experience, burden, and impacts on caregivers of patients with LVADs. OBJECTIVES: The aim of this study was to synthesize the qualitative literature regarding caregiver's perceptions about caring for an adult LVAD patient. METHODS: We searched MEDLINE, CINAHL, PsychInfo, and Web of Science to find English articles on the topic of LVAD caregiver's perceptions. The articles were then synthesized using a formal process of qualitative meta-synthesis. RESULTS: Eight articles met criteria for inclusion. The meta-synthesis across the articles resulted in 8 themes categorized under 3 domains. Many of the articles suggested a longitudinal process of caregiving with perceptions largely dependent upon the time of interview in relation to the LVAD. The first domain of caregiving is the "early" stage, covering the life before the LVAD through the procedure. This phase is characterized by the pre-LVAD "emotional rollercoaster," the decision seen as "no option," and the thought of "leave it [the LVAD] at the hospital." The second domain is the "middle" stage, covering the time frame after discharge from the hospital. This phase is characterized by fragility of the patient, recognition of a need to adapt, and a transformed life. The final domain is "late LVAD" and describes how late in the LVAD process the LVAD indication (bridge to transplant or destination therapy) brings in to focus what is important to caregivers. CONCLUSIONS: Existing literature indicates that the LVAD caregiver experience is intense as well as burdensome and entails the need to adapt to a new life. Given the burdens caregivers experience, clinicians and future research should explore strategies to support these important individuals.

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data.

BACKGROUND: Shared decision making is important to ensure that patients receive therapies aligned with their goals and values. Based upon a detailed needs assessment with diverse stakeholders, pamphlet and video decision aids for destination therapy left ventricular assist devices (DT LVAD) were developed to help patients and their caregivers think through, forecast, and deliberate their options. These decision aids are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD) study, a multicenter, randomized trial aimed at understanding the effectiveness and implementation of a shared decision support intervention for patients considering DT LVAD. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM framework and modeled after an effectiveness-implementation hybrid type II design. Six DT LVAD programs from across the United States will participate. Primary outcomes include knowledge and values-treatment concordance. Patients with advanced heart failure who are being considered for DT LVAD and their caregivers are eligible with a target enrollment of 168 dyads. From August 2014 to January 2015, an acceptability and feasibility pilot study was performed, which clarified opportunities and challenges around decision support for DT LVAD and resulted in significant modifications to the DECIDE-LVAD study. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including decision aids, with patients who have chronic progressive illness facing end-of-life decisions involving invasive, preference-sensitive therapy options.

Trust and activation in defining patient-clinician interactions for chronic disease management.

OBJECTIVE: Patient-clinician relationship quality and patient activation can both improve patient health outcomes, but prior work has primarily examined these factors independently. We examine how these two factors shape patient behavior in the setting of ambulatory heart failure care, where serial intensification of multiple medications is central to chronic care delivery. METHODS: We used content analysis to analyze 22 in-depth patient interviews and 32 audio-recorded clinic visits collected for the EPIC-HF Trial. This was a secondary analysis providing qualitative depth to the parent RCT. RESULTS: We identified a typology of patient activation and patient-clinician relationship quality, with four types: Supported, Skeptical, Deferential, and Unempowered. Types were sensitive to time and context; a given patient might occupy multiple types throughout the course of a single clinic visit. The effects of patient-activation and the patient-clinician relationship appeared to be bidirectional, with each influencing the other. CONCLUSION: Patient-clinician relationship quality and patient activation are dominant in shaping clinical interactions and disease management. This interaction is dynamic, and patients may change types depending on time, place, or context. PRACTICE IMPLICATIONS: These findings suggest that both patient activation and high relationship quality work together to create a supportive environment for chronic care, where intermittent skepticism, deference or empowerment may be useful at particular times or in certain situations.

Assessment of caregiver burden prior to implantation of left ventricular assist device: A national survey.

BACKGROUND: Guidelines recommend incorporation of caregiver burden assessment and list significant caregiver burden as a relative contraindication when considering left-ventricular assist device (LVAD) implantation. METHODS: To assess national practices regarding caregiver burden assessment, in 2019 we administered a 47-item survey to LVAD clinicians using 4 convenience samples. RESULTS: Responses were obtained from 191 registered nurses, 109 advance practice providers, 71 physicians, 59 social workers, and 40 others representing 132 LVAD programs; 125 of 173 total United States programs were included in the final analysis. While most programs (83.2%) assessed caregiver burden, assessment was most frequently conducted informally during social work evaluation (83.2%), with only 8.8% incorporating validated measures of caregiver burden. Larger programs were more likely to use a validated assessment measure (OR 6.68 [1.33-33.52]). CONCLUSIONS: Future research should focus on how programs can standardize caregiver burden assessment and how the level of burden may impact patient and caregiver outcomes.

Gender-based differences in decision making, quality of life and survival among patients undergoing left ventricular assist device evaluation.

BACKGROUND: Women are less likely to receive left ventricular assist devices and are more likely to experience poor outcomes. However, how gender impacts LVAD decision-making regarding LVAD implantation and the effects of that decision remains unknown. METHODS: We performed a sub-group analysis from the stepped-wedge DECIDE-LVAD trial, which tested a decision-support intervention for patients considering LVAD therapy. RESULTS: Excluding 9 patients who withdrew from assessments, of the 239 patients analyzed, 203 (85%) were men and 36 (15%) were women. More men received LVADs (70%) than women (61%) and more men were alive at 6 months compared to women, both among those who received LVADs (87% vs 82%) and those who did not (74% vs 50%) (p = 0.002). Compared to men, women were more likely to have decision regret, depressive symptoms and perceived stress at baseline but not at follow-up. At 6-month follow-up, men experience improvements in decisional conflict, acceptance of illness, struggle with illness, and perceived stress-none of those improvements were noted amongst women. Compared to men who received LVADs, women receiving LVADs had worse decision regret and depressive symptoms at baseline and worse acceptance of illness and perceived stress at six months. Men who received LVADs experienced improvement in decisional conflict and perceived stress, while women did not experience these improvements. Both men and women who received LVADs experienced improvement in depressive symptoms. Quality of life as assessed by EuroQol visual analog scale improved for both men and women who received LVADs but not for those who did not receive LVADs; no gender differences in quality of life were noted. CONCLUSION: Women require greater decisional support at time of decision to undergo LVAD implantation and subsequently might benefit from more intensive psychosocial support.

Patient control preferences for medical decision making before and after evaluation for left ventricular assist device.

Understanding patients' preferred roles in medical decision making (i.e., passive, collaborative, active) is important to personalized care and patient engagement. Patient control preferences have been described for many treatment decisions, but their stability over time has not been characterized, particularly for major medical events with long-term implications. We prospectively surveyed 233 patients at the initiation of evaluation for a left ventricular assist device, and 1 and 6 months later, including collection of the Control Preferences Scale. Collaborative and active preferences were most common initially, followed by a shift towards more active. Approximately half of patients reported a different control preference in follow up. Patients with higher income and education levels were more likely to prefer an active role. These findings suggest that most patients want to be engaged in shared decision making, but to what degree is varied, can change over time, and is influenced by social determinants of health.

Clinical Inertia Among Outpatients With Heart Failure: Application of Treatment Nonintensification Taxonomy to EPIC-HF Trial.

BACKGROUND: The contribution of clinical inertia to suboptimal guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) remains unclear. OBJECTIVES: This study examined reasons for GDMT nonintensification and characterized clinical inertia. METHODS: In this secondary analysis of EPIC-HF (Electronically Delivered, Patient-Activation Tool for Intensification of Medications for Chronic Heart Failure with Reduced Ejection Fraction), a randomized clinical trial evaluating a patient-activation tool on GDMT utilization, we performed a sequential, explanatory mixed-methods study. Reasons for nonintensification among 4 medication classes were assigned according to an expanded published taxonomy using structured chart reviews. Audio transcripts of clinic encounters were analyzed to further characterize nonintensification reasons. Integration occurred during the interpretation phase. RESULTS: Among 292 HFrEF patients who completed a cardiology visit, 185 (63.4%) experienced no treatment intensification, of whom 90 (48.6%) had at least 1 opportunity for intensification of a medication class with no documented contraindication or barriers (ie, clinical inertia). Nonintensification reasons varied by medication class, and included heightened risk of adverse effects (range 18.2%-31.6%), patient nonadherence (range 0.8%-1.1%), patient preferences and beliefs (range 0.6%-0.9%), comanagement with other providers (range 4.6%-5.6%), prioritization of other issues (range 15.6%-31.8%), multiple categories (range 16.5%-22.7%), and clinical inertia (range 22.7%-31.6%). A qualitative analysis of 32 clinic audio recordings demonstrated common characteristics of clinical inertia: 1) clinician review of medication regimens without education or intensification discussions; 2) patient stability as justification for nonintensification; and 3) shorter encounters for nonintensification vs intensification. CONCLUSIONS: In this comprehensive study exploring HFrEF prescribing, clinical inertia is a main contributor to nonintensification within an updated taxonomy classification for suboptimal GDMT prescribing. This approach should help target strategies overcoming GDMT underuse.

Changes over Time in Patient Stated Values and Treatment Preferences Regarding Aggressive Therapies: Insights from the DECIDE-LVAD Trial.

BACKGROUND: Patient-centered care includes matching treatments to patient values and preferences. This assumes clarity and consistency of values and preferences relevant to major medical decisions. We sought to describe stability of patient-reported values regarding aggressiveness of care and preferences for left ventricular assist devices (LVADs) for advanced heart failure. METHODS AND RESULTS: We conducted a secondary analysis of patients undergoing LVAD evaluation at 6 US centers. Surveys at baseline, 1 month, and 6 months included a single 10-point scale on the value of aggressive care (score 1 = "do everything," 10 = "live with whatever time I have left") and treatment preference (LVAD, unsure, no LVAD). Data were captured for 232 patients, of whom 196 were ultimately deemed medically eligible for LVAD, and 161 were surgically implanted by 1 month. Values at baseline favored aggressive care (mean [SD], 2.49 [2.63]), trending toward less aggressive over time (1 month, 2.63 [2.05]; 6 months, 3.22 [2.70]). Between baseline and 1 month, values scores changed by ≥2 points in 28% (50/176), as did treatment preferences for 18% (29/161) of patients. Values score changes over time were associated with lower illness acceptance, depression, and eventual LVAD ineligibility. Treatment preference change was associated with values score change. CONCLUSION: Most patients considering LVAD were stable in their values and treatment preferences. This stability, as well as the association between unstable treatment preferences and changes to stated values, highlighted the clinical utility of the values scale of aggressiveness. However, a substantial minority reported significant changes over time that may complicate the process of shared decision making. Improved methods to elicit and clarify values, including support to those with depression and low illness acceptance, is critical for patient-centered care.[Box: see text].

Stress and Coping Among Family Caregivers of Patients With a Destination Therapy Left Ventricular Assist Device: A Multicenter Mixed Methods Study.

BACKGROUND: Family caregivers of patients with a destination therapy left ventricular assist device play a central and formalized role in postimplant care. We aimed to characterize longitudinal stress, predictors and correlates of stress, and coping processes among left ventricular assist device caregivers. METHODS: We performed a sequential, exploratory, mixed-methods study from 6 diverse left ventricular assist device programs. The primary outcome for the quantitative analysis was the Perceived Stress Scale-10 at 6 months (0-40). Based on the quantitative findings and guided by the Transactional Model of Stress and Coping, semistructured interviews explored causes of stress and coping processes. Integration was performed during the qualitative and interpretation phase. RESULTS: A total of 96 caregivers met inclusion criteria for quantitative analysis. Mean (SD) Perceived Stress Scale score was 14.3 (5.5) preimplant and 11.8 (6.9) at 6 months. Preimplant, only decreased preparedness for caregiving was associated with higher Perceived Stress Scale score at 6 months. At 6 months, increased caregiver depressive symptoms, decreased caregiver preparedness for caregiving, and lower patient quality of life were associated with higher Perceived Stress Scale score. Qualitative analysis of 25 caregivers revealed the causes of stress coalesced around 3 themes: (1) lack of preparedness to be a caregiver, (2) uniqueness of stress for the caregiver and patient situation, and (3) caregiving responsibilities physically and emotionally impacting caregivers. To cope with stress, most caregivers employed emotion-focused coping. CONCLUSIONS: In family caregivers of patients with a left ventricular assist device, higher perceived stress was associated with lower caregiver preparedness, higher caregiver depressive symptoms, and lower patient quality of life. Emotion-focused coping strategies were common for caregivers. Future work should better prepare caregivers for this role and support them through the caregiving experience. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

Shared Decision-Making for Left Ventricular Assist Devices: Rationale and Design of a Nationwide Dissemination and Implementation Project.

Background The left ventricular assist device (LVAD) has become a common medical option for patients with end-stage heart failure. Although patients' chances of survival may increase with an LVAD compared with medical therapy, the LVAD poses many risks and requires major lifestyle changes, thus making it a complex medical decision. Our prior work found that a decision aid for LVADs significantly increased decision quality for both patients and caregivers and was successfully implemented at 6 LVAD programs. Methods In follow-up, we are conducting a nationwide dissemination and implementation project, with the goal of implementing the decision aid at as many of the 176 LVAD programs in the United States as possible. Guided by the Theory of Diffusion of Innovations, the project consists of 4 phases: (1) building a network; (2) promoting adoption; (3) supporting implementation; and (4) encouraging maintenance. Developing an LVAD network of contacts occurs by using a national baseline survey of LVAD clinicians, existing professional relationships, and an internet-based strategy. A suite of resources targeted to promote adoption and support implementation of the decision aid into standard LVAD education processes are provided to the network. Evaluation is guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance framework, where clinician and patient surveys and qualitative interviews determine the reach, effectiveness, adoption, implementation, and maintenance achieved. Conclusions This project is a true dissemination study in that it targets the entire population of LVAD programs in the United States and is unique in its use of social marketing principles to promote adoption and implementation. The implementation plan is intended to serve as a test case and model for dissemination and implementation of other evidence-based decision support aids and strategies.

Perceived Stress and Depressive Symptoms as Predictors of Decisional Conflict in Dyads Considering a Left Ventricular Assist Device.

BACKGROUND: The decision to pursue a left ventricular assist device (LVAD) commits loved ones to major caregiving responsibilities and, often, medical decision-making. How emotional domains overlap within patients and their caregivers and contribute to conflict around the decision to pursue LVAD remains largely unexplored. METHODS AND RESULTS: The associations within and between individuals in patient-caregiver dyads considering LVAD were estimated in a specific type of structural equation model known as the Actor-Partner Interdependence Model. This model tested whether each person's depression and stress predicted their own decisional conflict (actor effects), as well as their partner's decisional conflict (partner effects). At the time of study enrollment when a formal LVAD evaluation was initiated, 162 patient-caregiver dyads completed assessments of decisional conflict using the Decisional Conflict Scale, depressive symptoms using the Patient Health Questionnaire-2, and stress using the Perceived Stress Scale. Across both models, decisional conflict was significantly correlated within patient-caregiver dyads (ß=0.47 and 0.44, for depression and perceived stress models, respectively, P<0.001). Greater perceived stress in both the patient (ß=0.18; P<0.05) and caregiver (ß=0.28; P<0.001) was significantly related to greater decisional conflict (both actor effects). Greater patient depressive symptoms were related to greater patient decisional conflict (ß=0.16; P<0.05), whereas caregiver depression symptoms was not related to their own decisional conflict (ß=0.07; P=0.37). There were no partner effects identified between decisional conflict and perceived stress or depressive symptoms. CONCLUSIONS: Patient and caregiver conflict over the decision to pursue an LVAD was highly correlated in this sample, with greater perceived stress significantly predicting greater decisional conflict in both patients and caregivers. Depressive symptoms in patients also predicted greater patient decisional conflict. No partner effects were identified in predicting decisional conflict. These results contribute to a larger body of work acknowledging the importance of patient-caregiver well-being in serious illness. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02344576.

Decision Aid Implementation among Left Ventricular Assist Device Programs Participating in the DECIDE-LVAD Stepped-Wedge Trial.

Background. Despite demonstrated efficacy, patient decision aids (DAs) are rarely used in clinical practice in the absence of coverage mandates. Deciding whether to pursue a left ventricular assist device (LVAD) is a major, preference-sensitive decision-ideal for exploring implementation of a DA. Methods. We conducted a type II effectiveness-implementation hybrid trial at 6 LVAD programs using a stepped-wedge cluster-randomized design. Using the RE-AIM framework, we collected both quantitative and qualitative outcomes, including a checklist collected by study staff for each enrolled patient regarding DA use and interviews with LVAD program clinicians preintervention, 6 months postintervention, and at the conclusion of the study. Results. From June 2015 to January 2017, 248 patients and their caregivers were enrolled. A total of 69 interviews were conducted with 48 clinicians at 3 time points. The DA reached 95% of eligible patients. Adoption was 100%, as all sites approached agreed to participate in the trial. Interviews revealed several themes related to the implementation of the DA: clinicians had a strong desire to ensure patients were informed and embraced the DA. Despite this, they reported communication challenges among their team that impeded implementation. Five of the 6 sites have maintained use of the DA following the trial; 1 site reported concerns about decreased procedural volume with use of the DA as a reason for discontinuation. Conclusions. In this hybrid trial, a DA for patients considering LVADs and their caregivers demonstrated high reach. Adoption and implementation were facilitated by a strong desire to ensure that patients were well informed. Future dissemination research and practice should attend to concerns about procedure volume and coverage mandates and facilitate ongoing communication at sites using the DA.