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.

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.

A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.

Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.

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.

Atrial Fibrillation in Heart Failure US Ambulatory Cardiology Practices and the Potential for Uptake of Catheter Ablation: An National Cardiovascular Data Registry (NCDR®) Research to Practice (R2P) Project.

BACKGROUND: Atrial fibrillation (AF) and heart failure with reduced ejection fraction frequently coexist. The AATAC (Ablation versus Amiodarone for Treatment of persistent Atrial fibrillation in patients with Congestive heart failure and an implantable device) trial suggests that catheter ablation may benefit these patients. However, applicability to contemporary ambulatory cardiology practice is unknown. METHODS AND RESULTS: Using the outpatient National Cardiovascular Data Registry® Practice Innovation and Clinical Excellence Registry, we identified participants meeting AATAC enrollment criteria between 2013 and 2014. Treatment with medications and procedures was assessed at registry inclusion. From 164 166 patients with AF and heart failure, 8483 (7%) patients potentially met AATAC inclusion criteria. Eligible subjects, compared to AATAC trial participants, were older (mean age, 71.2±11.4 years) and had greater comorbidity (coronary artery disease 79.2%, hypertension 82.4%, and diabetes mellitus 31.8%). AF was predominantly paroxysmal (65.5%), rather than persistent/permanent (16.7%) or new onset (17.8%), whereas all patients in the AATAC trial had persistent AF. Commonly used atrioventricular-nodal blocking agents were carvedilol (71.2%), digoxin (31.9%), and metoprolol (27.1%). Rhythm control with anti-arrhythmic drugs was reported in 29.0% of AATAC eligible patients (predominantly amiodarone [24.6%]) and 9.3% had undergone catheter ablation. Patients who underwent ablation were more likely to be younger and have less comorbidities than those who did not. CONCLUSIONS: Among the contemporary ambulatory AF/heart failure with reduced ejection fraction population, treatment is predominantly rate control with few catheter ablations. Application of AATAC findings has the potential to markedly increase the use of catheter ablation in this population, although significant differences in clinical profiles might influence ablation outcomes in practice.

Practice-level variation in use of recommended medications among outpatients with heart failure: Insights from the NCDR PINNACLE program.

BACKGROUND: The objective of this study is to examine practice-level variation in rates of guideline-recommended treatment for outpatients with heart failure and reduced ejection fraction, and to examine the association between treatment variation and practice site, independent of patient factors. METHODS AND RESULTS: Cardiology practices participating in the National Cardiovascular Disease Registry Practice Innovation and Clinical Excellence registry from July 2008 to December 2010 were evaluated. Practice rates of treatment with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers and ß-blockers and an optimal combined treatment measure were determined for patients with heart failure and reduced ejection fraction and no documented contraindications. Multivariable hierarchical regression models were adjusted for demographics, insurance status, and comorbidities. A median rate ratio was calculated for each therapy, which describes the likelihood that the treatment of a patient with given comorbidities would differ at 2 randomly selected practices. We identified 12 556 patients from 45 practices. The unadjusted practice-level prescription rates ranged from 44% to 100% for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (median, 85%; interquartile range, 75%-89%), from 49% to 100% for ß-blockers (median, 92%; interquartile range, 83%-95%), and from 37% to 100% for optimal combined treatment (median, 79%; interquartile range, 66%-85%). The adjusted median rate ratio was 1.11 (95% confidence interval, 1.08-1.18) for angiotensin-converting enzyme inhibitors/angiotensin receptor blockers therapy, 1.08 (95% confidence interval, 1.05-1.15) for ß-blockers therapy, and 1.17 (1.13-1.26) for optimal combined treatment. CONCLUSIONS: Variation in the use of guideline-recommended medications for patients with heart failure and reduced ejection fraction exists in the outpatient setting. Addressing practice-level differences may be an important component of improving quality of care for patients with heart failure and reduced ejection fraction.