ABSTRACT
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.
Subject(s)
Heart Failure , Heart Ventricles , Heart-Assist Devices , Caregivers , Decision Making, Shared , Heart Failure/diagnosis , Heart Failure/therapy , HumansABSTRACT
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.
Subject(s)
Decision Making, Shared , Heart Failure , Patient Participation , Practice Patterns, Physicians' , Stroke Volume , Adult , Female , Health Services Misuse , Heart Failure/drug therapy , Heart Failure/physiopathology , Heart Failure/psychology , Humans , Internet-Based Intervention , Male , Patient Participation/methods , Patient Participation/psychology , Physician-Patient Relations , Quality Improvement , Randomized Controlled Trials as Topic , Ventricular Dysfunction, Left/diagnosisSubject(s)
Betacoronavirus , Coronavirus Infections/therapy , Delivery of Health Care/trends , Heart Failure/therapy , Pandemics , Pneumonia, Viral/therapy , Surveys and Questionnaires , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Delivery of Health Care/methods , Heart Failure/diagnosis , Heart Failure/epidemiology , Humans , Physicians/trends , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , SARS-CoV-2ABSTRACT
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.