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.

Looking Cool, Doing Tricks, Managing Stress, and Nicotine Addiction: Youth Perspectives on Nicotine Vaping and Implications for Prevention.

PURPOSE: To understand the contextual and psychosocial factors associated with youth vaping in Colorado, the state with the highest youth vaping rates in 2019, and to propose strategies for prevention interventions. DESIGN: Focus groups. SETTING: In-person. PARTICIPANTS: 24 youth aged 11-17, including youth who had vaped (n = 11) and who had never vaped (n = 13). METHOD: Qualitative responses using a semi-structured focus group guide were analyzed using a matrix approach with a mixed deductive/inductive content analysis. RESULTS: Analysis revealed the highly social nature of vaping initiation and use; the use of vaping to control negative emotions; and the acquisition of vaping products through retail outlets, friends, family, and other youth who sell a variety of substances and devices to youth. Youth provided insight into how vaping is concealed from parents and teachers, and their attitudes about the health risks and benefits of vaping. CONCLUSION: When considered with other studies, our findings suggest a universality in the youth vaping experience that is highly social. Interventions should include peer-to-peer messaging with an emphasis on changing social norms and highlighting undesirable outcomes of vaping such as negative reactions by friends and close adults, adverse effects on athletic success and future aspirations, expense, addiction, and punishment. Parent education is also recommended. Rigorous research is needed to test interventions to reverse the growing trend of youth vaping.

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.

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.

Patient Roadmaps for Chronic Illness: Introducing a New Approach for Fostering Patient-Centered Care.

Background. Too frequently, patients with chronic illnesses are surprised by disease-related changes and are unprepared to make decisions based on their values. Many patients are not activated and do not see a role for themselves in decision making, which is a key barrier to shared decision making and patient-centered care. Patient decision aids can educate and activate patients at the time of key decisions, and yet, for patients diagnosed with chronic illness, it would be advantageous to activate patients in advance of critical decisions. In this article, we describe and formalize the concept of the Patient Roadmap, a novel approach for promoting patient-centered care that aims to activate patients earlier in the care trajectory and provide them with anticipatory guidance. Methods. We first identify the gap that the Patient Roadmap fills, and describe theory underlying its approach. Then we describe what information a Patient Roadmap might include. Examples are provided, as well as a review comparing the Patient Roadmap concept to existing tools that aim to promote patient-centered care (e.g., patient decision aids). Results and Conclusions. New approaches for promoting patient-centered care are needed. This article provides an introduction and overview of the Patient Roadmap concept for promoting patient-centered care in the context of chronic illness.