User-Centered Evaluations with Older Adults: Testing the Usability of a Mobile Health System for Heart Failure Self-Management

Many older adults living with heart failure struggle to follow recommended self-management routines. To help older adults with heart failure more effectively and efficiently self-manage their disease, we developed Engage, a mobile health application promoting the performance, logging, and sharing of routine self-management behaviors. This paper reports on the usability evaluation of the Engage system with 15 older adults with heart failure and informal caregivers. In two phases, participants used Engage during a task-based usability test (n=5) and a scenario-based usability test (n=10). Usability and performance data were assessed through video-recorded observation and the administration of the system usability scale (SUS) and NASA Task Load Index (TLX). We found that task-based testing was useful in quickly identifying problems within our application, but scenario-based testing elicited more valuable feedback from older adults. A comparison of the different evaluation methods used and the discussion of the challenges encountered provide multiple implications for the practice of usability testing of mobile health products with older adults

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

Involving patients as key stakeholders in the design of cardiovascular implantable electronic device data dashboards: Implications for patient care

Background: Data from remote monitoring (RM) of cardiovascular implantable electronic devices (CIEDs) currently are not accessible to patients despite demand. The typical RM report contains multiple pages of data for trained technicians to read and interpret and requires a patient-centered approach to be curated to meet individual user needs. Objective: The purpose of this study was to understand which RM data elements are important to patients and to gain design insights for displaying meaningful data in a digital dashboard. Methods: Adults with implantable cardioverter-defibrillators (ICDs) and pacemakers (PMs) participated in this 2-phase, user-centered design study. Phase 1 included a card-sorting activity to prioritize device data elements. Phase 2 included one-on-one design sessions to gather insights and feedback about a visual display (labels and icons). Results: Twenty-nine adults (mean age 71.8 ± 11.6 years; 51.7% female; 89.7% white) participated. Priority data elements for both ICD and PM groups in phase 1 (n = 19) were related to cardiac episodes, device activity, and impedance values. Recommended replacement time for battery was high priority for the PM group but not the ICD group. Phase 2 (n = 10) revealed that patients would like descriptive, nontechnical terms to depict the data and icons that are intuitive and informative. Conclusion: This user-centered design study demonstrated that patients with ICDs and PMs were able to prioritize specific data from a comprehensive list of data elements that they had never seen before. This work contributes to the goal of sharing RM data with patients in a way that optimizes the RM feature of CIEDs for improving patient outcomes and clinical care

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

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

Pravastatin for early-onset pre-eclampsia:a randomised, blinded, placebo-controlled trial

Objective: Women with pre-eclampsia have elevated circulating levels of soluble fms-like tyrosine kinase-1 (sFlt-1). Statins can reduce sFlt-1 from cultured cells and improve pregnancy outcome in animals with a pre-eclampsia-like syndrome. We investigated the effect of pravastatin on plasma sFlt-1 levels during pre-eclampsia. Design: Blinded (clinician and participant), proof of principle, placebo-controlled trial. Setting: Fifteen UK maternity units. Population: We used a minimisation algorithm to assign 62 women with early-onset pre-eclampsia (24 +0–31 +6 weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth. Primary outcome: Difference in mean plasma sFlt-1 levels over the first 3 days following randomisation. Results: The difference in the mean maternal plasma sFlt-1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI −1175 to 592; P = 0.5), and over days 1–14 was 48 pg/ml (95% CI −1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50–1.40; P = 0.6). The median time from randomisation to childbirth was 9 days [interquartile range (IQR) 5–14 days] for the pravastatin group and 7 days (IQR 4–11 days) for the placebo group. There were three perinatal deaths in the placebo-treated group and no deaths or serious adverse events attributable to pravastatin. Conclusions: We found no evidence that pravastatin lowered maternal plasma sFlt-1 levels once early-onset pre-eclampsia had developed. Pravastatin appears to have no adverse perinatal effects. Tweetable abstract: Pravastatin does not improve maternal plasma sFlt-1 or placental growth factor levels following a diagnosis of early preterm pre-eclampsia #clinicaltrial finds

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570