Clinician use of data elements from cardiovascular implantable electronic devices in clinical practice.

Background: Cardiovascular implantable electronic devices (CIEDs) capture an abundance of data for clinicians to review and integrate into the clinical decision-making process. The multitude of data from different device types and vendors presents challenges for viewing and using the data in clinical practice. Efforts are needed to improve CIED reports by focusing on key data elements used by clinicians. Objective: The purpose of this study was to uncover the extent to which clinicians use the specific types of data elements from CIED reports in clinical practice and explore clinicians' perceptions of CIED reports. Methods: A brief, web-based, cross-sectional survey study was deployed using snowball sampling from March 2020 through September 2020 to clinicians who are involved in the care of patients with CIEDs. Results: Among 317 clinicians, the majority specialized in electrophysiology (EP) (80.1%), were from North America (88.6%), and were white (82.2%). Over half (55.3%) were physicians. Arrhythmia episodes and ventricular therapies rated the highest among 15 categories of data presented, and nocturnal or resting heart rate and heart rate variability were rated the lowest. As anticipated, clinicians specializing in EP reported using the data significantly more than other specialties across nearly all categories. A subset of respondents offered general comments describing preferences and challenges related to reviewing reports. Conclusion: CIED reports contain an abundance of information that is important to clinicians; however, some data are used more frequently than others, and reports could be streamlined for users to improve access to key information and facilitate more efficient clinical decision making.

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.

Organizational Models for Cardiac Implantable Electronic Device Remote Monitoring: Current and Future Directions.

This review provides an overview of the literature on the organization, staffing, and structure of remote monitoring (RM) clinics, primarily from countries in Western Europe and United States, as well as the challenges, considerations, and future directions for RM clinic models of care. Using a current case example of an RM clinic in the Midwestern United States, this document provides key information from the viewpoint of a clinic undergoing a shift in workflow. Finally, this review distills key considerations for RM management for electrophysiology clinics, vendors and industry, and policy makers.

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.

Can nurses help improve self-care of patients living with atrial fibrillation? A focus group study exploring patients' disease knowledge gaps.

Aims: To identify knowledge gaps and preferences for educational material to improve nurse-patient communication and self-care. Design: Using a mixed-methods design, we conducted focus groups and quantitative surveys. Methods: We conducted three focus groups with atrial fibrillation (AF) patients and support persons (N = 17 participants; 66 ± 16 years) at critical treatment junctures (recent diagnosis or medication switch). Patients and support persons were also surveyed on patient activation (self-management skills and knowledge), medication adherence, AF knowledge and health literacy. Iterative thematic analysis was performed using focus group transcripts. Results: Although most participants had adequate health literacy, most reported gaps in AF knowledge. Participants lacked disease-related knowledge and were unsure how to manage health behaviours (e.g. diet and exercise). Few felt they received adequate education from their healthcare provider. Results emphasize the need for consistent information from nursing staff, in lay language, via both electronic and printed means.

Patient decision-making personas: An application of a patient-centered cognitive task analysis (P-CTA).

Personas can be used to understand patterns of variation in patients' performance of cognitive work, particularly self-care decision making. In this study, we used a patient-centered cognitive task analysis (P-CTA) to develop self-care decision-making personas. We collected data from 24 older adults with chronic heart failure and 14 support persons, using critical incident and fictitious scenario interviews. Qualitative analyses produced three personas but revealed that individuals exemplify different personas across situations. The Rule-Following persona seeks clear rules, exercises caution under uncertainty, and grounds actions in confidence in clinician experts. The Researching persona seeks information to gain better understanding, invents strategies, and conducts experiments independently or with clinicians. The Disengaging persona does not actively seek rules or information and does not attempt to reduce uncertainty or conduct experiments. We discuss the situational nature of personas, their use in design, and the benefits of P-CTA for studying patient 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.

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.

Visualization of Cardiac Implantable Electronic Device Data for Older Adults Using Participatory Design.

Patients with heart failure (HF) are commonly implanted with cardiac resynchronization therapy (CRT) devices as part of their treatment. Presently, they cannot directly access the remote monitoring (RM) data generated from these devices, representing a missed opportunity for increased knowledge and engagement in care. However, electronic health data sharing can create information overload issues for both clinicians and patients, and some older patients may not be comfortable using the technology (i.e., computers and smartphones) necessary to access this data. To mitigate these problems, patients can be directly involved in the creation of data visualization tailored to their preferences and needs, allowing them to successfully interpret and act upon their health data. We held a participatory design (PD) session with seven adult patients with HF and CRT device implants, who were presently undergoing RM, along with two informal caregivers. Working in three teams, participants used drawing supplies and design cards to design a prototype for a patient-facing dashboard with which they could engage with their device data. Information that patients rated as a high priority for the "Main Dashboard" screen included average percent pacing with alerts for abnormal pacing, other device information such as battery life and recorded events, and information about who to contact with for data-related questions. Preferences for inclusion in an "Additional Information" display included a daily pacing chart, health tips, aborted shocks, a symptom list, and a journal. These results informed the creation of an actual dashboard prototype which was later evaluated by both patients and clinicians. Additionally, important insights were gleaned regarding the involvement of older patients in PD for health technology.

Knowledge among patients with heart failure: A narrative synthesis of qualitative research.

BACKGROUND: Patients' knowledge of heart failure (HF) is integral to improved outcomes. However, the HF literature has not adequately explored the nature of patients' knowledge of HF as part of their lived experience. OBJECTIVES: We aimed to characterize the nature of patients' knowledge of HF, in the context of living with the disease. METHODS: We conducted a narrative synthesis of qualitative studies that addressed patients' knowledge of HF. Studies were systematically searched and retrieved from MEDLINE, CINAHL, PsycINFO and PsycARTICLES databases. Findings were synthesized using an iterative coding process carried out by multiple analysts and reported following Enhancing Transparency in the Reporting of Qualitative Health Research (ENTREQ) criteria. RESULTS: Analysis of 73 eligible articles produced five themes: the content that comprises HF knowledge; development of HF knowledge over time; application of HF knowledge for decision making; communication of information between clinicians and patients; and patients' experience of knowledge. CONCLUSION: The nature of patients' knowledge of HF is both explicit and implicit, dynamic, and personal. This multidimensional model of knowledge-in-context calls for equally multidimensional research and intervention design.

Data Integration and Interoperability for Patient-Centered Remote Monitoring of Cardiovascular Implantable Electronic Devices.

The prevalence of cardiovascular implantable electronic devices with remote monitoring capabilities continues to grow, resulting in increased volume and complexity of biomedical data. These data can provide diagnostic information for timely intervention and maintenance of implanted devices, improving quality of care. Current remote monitoring procedures do not utilize device diagnostics to their potential, due to the lack of interoperability and data integration among proprietary systems and electronic medical record platforms. However, the development of a technical framework that standardizes the data and improves interoperability shows promise for improving remote monitoring. Along with encouraging the implementation of this framework, we challenge the current paradigm and propose leveraging the framework to provide patients with their remote monitoring data. Patient-centered remote monitoring may empower patients and improve collaboration and care with health care providers. In this paper, we describe the implementation of technology to deliver remote monitoring data to patients in two recent studies. Our body of work explains the potential for developing a patent-facing information display that affords the meaningful use of implantable device data and enhances interactions with providers. This paradigm shift in remote monitoring-empowering the patient with data-is critical to using the vast amount of complex and clinically relevant biomedical data captured and transmitted by implantable devices to full potential.

Delivering remote monitoring data to patients with implantable cardioverter-defibrillators: Does medium matter?

BACKGROUND: This study presents findings on the impact of providing patients with their implantable device data on patients' satisfaction, engagement, healthcare utilization, and provider's perceptions of this practice. Remote monitoring of implantable cardioverter defibrillators (ICDs) improves patient care through timely delivery of ICD data to the clinic. However, patients usually do not receive their ICD data. Providers are concerned that messaging patients with their device data could increase clinical workload. METHODS: To evaluate the impact of sharing ICD data summary through the patient portal, 128 patients were randomized into two groups. Group A and B received their data through the patient portal and postal mail, respectively. Data were collected through surveys and medical record reviews. Forty-eight providers also completed a survey. RESULTS: At the end of the study, at least two-thirds of patients were satisfied with the amount of information received through the electronic or paper ICD data summary. Additionally, providing patients with their device data did not increase ICD-specific clinical workload (e.g., calls or messages to provider). While providers did not foresee the provision of ICD data to patients as decreasing or improving clinical workload, they did see potential value in it for patients. CONCLUSIONS: Providing patients with their ICD data (through paper or electronic means) might have the potential to improve patient satisfaction and enhance shared-decision making without adversely impacting clinical workload.

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.

Impact of electronic personal health record use on engagement and intermediate health outcomes among cardiac patients: a quasi-experimental study.

OBJECTIVES: To determine the impact of tethered personal health record (PHR) use on patient engagement and intermediate health outcomes among patients with coronary artery disease (CAD). METHODS: Adult CAD patients (N = 200) were enrolled in this prospective, quasi-experimental observational study. Each patient received a PHR account and training on its use. PHRs were populated with information from patient electronic medical records, hosted by a Health Information Exchange. Intermediate health outcomes including blood pressure, body mass index, and hemoglobin A1c (HbA1c) were evaluated through electronic medical record review or laboratory tests. Trends in patient activation measure® (PAM) were determined through three surveys conducted at baseline, 6 and 12 months. Frequency of PHR use data was collected and used to classify participants into groups for analysis: Low, Active, and Super users. RESULTS: There was no statistically significant improvement in patient engagement as measured by PAM scores during the study period. HbA1c levels improved significantly in the Active and Super user groups at 6 months; however, no other health outcome measures improved significantly. Higher PAM scores were associated with lower body mass index and lower HbA1c, but there was no association between changes in PAM scores and changes in health outcomes. Use of the PHR health diary increased significantly following PHR education offered at the 6-month study visit and an elective group refresher course. CONCLUSIONS: The study findings show that PHR use had minimal impact on intermediate health outcomes and no significant impact on patient engagement among CAD patients.