Patient-centered Design Grounded in User and Clinical Realities: Towards Valid Digital Health

Valid design of patient-centered digital health or health information technology (IT) systems is based on a thorough and accurate understanding of both “user reality” and “clinical reality.” Type 1 Design Error (User-Reality Error) occurs when designers do not accommodate user characteristics, tasks, context of use, needs, or preferences. Type 2 Design Error (Clinical-Reality Error) occurs when designers do not accommodate the clinical reality, including biomedical knowledge, clinical workflows, and organizational requirements. Both types of errors can invalidate the design, leading to products being rejected by patient end-users or their healthcare delivery systems, product non-use or inappropriate use, and risk of harm. This paper describes our attempts to achieve valid health IT design and avoid the two design errors. We performed iterative, patient-centered design to prototype a mobile application, Power to the Patient (P2P), supporting heart failure self-care management. Our multidisciplinary team of human factors, cardiology, and design experts developed and iteratively refined requirements based on data collection, review, and testing with patient research participants, a patient advisory board, a clinical advisory board, and experts on the team. We describe our process and reflect on working with multiple stakeholders toward the goal of valid health IT design

Erratum to: Providing Patients with Implantable Cardiac Device Data through a Personal Health Record: A Qualitative Study

Erratum to: Providing Patients with Implantable Cardiac Device Data through a Personal Health Record: A Qualitative Study. [Appl Clin Inform. 2017

Naturalistic Decision Making in Everyday Self-care Among Older Adults With Heart Failure

BACKGROUND: Every day, older adults living with heart failure make decisions regarding their health that may ultimately affect their disease trajectory. Experts describe these decisions as instances of naturalistic decision making influenced by the surrounding social and physical environment and involving shifting goals, high stakes, and the involvement of others. OBJECTIVE: This study applied a naturalistic decision-making approach to better understand everyday decision making by older adults with heart failure. METHODS: We present a cross-sectional qualitative field research study using a naturalistic decision-making conceptual model and critical incident technique to study health-related decision making. The study recruited 24 older adults with heart failure and 14 of their accompanying support persons from an ambulatory cardiology center. Critical incident interviews were performed and qualitatively analyzed to understand in depth how individuals made everyday health-related decisions. RESULTS: White, male (66.7%), older adults' decision making accorded with a preliminary conceptual model of naturalistic decision making occurring in phases of monitoring, interpreting, and acting, both independently and in sequence, for various decisions. Analyses also uncovered that there are barriers and strategies affecting the performance of these phases, other actors can play important roles, and health decisions are made in the context of personal priorities, values, and emotions. CONCLUSIONS: Study findings lead to an expanded conceptual model of naturalistic decision making by older adults with heart failure. In turn, the model bears implications for future research and the design of interventions grounded in the realities of everyday decision making

Untold Stories in User-Centered Design of Mobile Health: Practical Challenges and Strategies Learned From the Design and Evaluation of an App for Older Adults With Heart Failure

Background User-centered design (UCD) is a powerful framework for creating useful, easy-to-use, and satisfying mobile health (mHealth) apps. However, the literature seldom reports the practical challenges of implementing UCD, particularly in the field of mHealth. Objective This study aims to characterize the practical challenges encountered and propose strategies when implementing UCD for mHealth. Methods Our multidisciplinary team implemented a UCD process to design and evaluate a mobile app for older adults with heart failure. During and after this process, we documented the challenges the team encountered and the strategies they used or considered using to address those challenges. Results We identified 12 challenges, 3 about UCD as a whole and 9 across the UCD stages of formative research, design, and evaluation. Challenges included the timing of stakeholder involvement, overcoming designers’ assumptions, adapting methods to end users, and managing heterogeneity among stakeholders. To address these challenges, practical recommendations are provided to UCD researchers and practitioners. Conclusions UCD is a gold standard approach that is increasingly adopted for mHealth projects. Although UCD methods are well-described and easily accessible, practical challenges and strategies for implementing them are underreported. To improve the implementation of UCD for mHealth, we must tell and learn from these traditionally untold stories

Diaphragmatic function in cardiovascular disease: JACC review topic of the week

In addition to the diaphragm’s role as the primary respiratory muscle, it also plays an under-recognized role in cardiac function. It serves as a pump facilitating venous and lymph return, modulating left ventricular afterload hemodynamics and pericardial pressures, as well as regulating autonomic tone. Heart failure (HF) is associated with diaphragmatic changes (ie, muscle fiber atrophy and weakness, increased ratio of type I to type II muscle fibers, and altered muscle metaboreflex) that lead to diaphragmatic dysfunction with subsequent symptomatic manifestations of HF. Herein, it is proposed that targeting the diaphragm in patients with HF via inspiratory muscle training or device-based stimulation can provide a novel treatment pathway for HF. Reviewed are several potential mechanisms through which therapies targeting the diaphragm can be beneficial in HF (ie, improving preload reserve, atrial and ventricular synchrony, and metaboreflex activity; reducing pericardial restraint; and restoring diaphragm strength)

Patient responses to daily cardiac resynchronization therapy device data: A pilot trial assessing a novel patient-centered digital dashboard in everyday life

Background Heart failure (HF) is a growing public health problem in the United States. Implantable cardiac resynchronization therapy (CRT) devices reduce mortality and morbidity, and remote monitoring (RM) of these devices improves outcomes. However, patient RM adherence is low, due in part to lack of access to their RM data. Providing these data to patients may increase engagement, but they must be appropriately tailored to ensure understanding. Objective The purpose of this study was to examine patients’ experiences interacting with their RM data through a novel digital dashboard as part of daily life. Methods In this mixed-methods pilot study, 10 patients with implantable CRT defibrillators were given access to a patient-centered RM data dashboard, updated daily for 6–12 months. Pre- and post-health literacy, engagement, electronic portal (MyChart, Epic Systems Corporation) logins, and RM adherence were measured; system usability scores were collected at exit; and dashboard views were tracked. Exit interviews were conducted to elucidate patients’ experiences. Results Participants (100% white; 60% male; age 34–80 years [mean ± SD: 62.0 ± 13.4]) had adequate health literacy, increased MyChart logins (P = .0463), and nonsignificant increase in RM adherence. Participants viewed their dashboards 0–42 times (mean 14.9 ± 12.5). Interviews revealed participants generally appreciated access to their data, understood it, and responded to changes; however, questions and concerns remained regarding data interpretation and visualization. Conclusion Preliminary findings support potential future integration of a CRT RM data dashboard in the daily care of HF patients. With appropriate informational support and personalization, sharing RM data with patients in a tailored dashboard may improve health engagement

Uncertainty Management Among Older Adults with Heart Failure: Responses to Receiving Implanted Device Data using a Fictitious Scenario Interview Method

Heart failure (HF) is a complex chronic illness that affects the older adult population, requiring medical therapy and day-to-day management to prevent worsening and exacerbation. Patients with HF are often treated with cardiac implanted electronic devices (CIEDs) which capture diagnostic and predictive parameters for HF. In this work we explore how patients would respond to receiving data from an implanted device, using a fictitious scenario interview method with 24 older adults with HF. We applied an uncertainty management lens to better understand how patients face uncertain outcomes and integrate novel data into their decision making. The findings provide insight into how patients would engage and respond to a technology which provides an indicator of their HF status from an implanted device