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.

Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post-approval study.

BACKGROUND: Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S-ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three-incision technique [3IT]). A two-incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow-up. OBJECTIVES: To report on the long-term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort. METHODS: Patients enrolled in the S-ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S-ICD effectiveness in treating ventricular arrhythmias through an average 3-year follow-up period were compared. RESULTS: Of 1637 patients enrolled in the S-ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1-Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p < .0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias. CONCLUSION: In this large cohort of patients implanted with an S-ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time.

Playing it close to the VEST and the clinical guidelines: Clinical guideline compliance in HFrEF patients-Role of WCD.

BACKGROUND: Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) has been challenging to achieve universally. Healthcare providers who seek to achieve optimal medical therapy frequently consider either a wearable cardioverter defibrillator (WCD) or an implantable cardioverter defibrillator (ICD) as indicated. The dynamic process of communication and physician recommendations marks a setting to study the relative interdependence of medical therapies and best practice. The purpose of this study was to examine the long-term impact of the WCD on GDMT. We hypothesized the WCD serves as a "gateway" therapy, likely impacting other optimal strategies such that successful use of WCD improves GDMT adherence. METHODS: Electronic medical records (EPIC) were manually reviewed to extract data elements in this observational study of 1289 HFrEF patients from 2013-2015. Data included demographics, comorbidities, and use of GDMT including an ICD use in persistently low ejection fraction (≤36%) patients after 90 days. RESULTS: WCD use was significantly associated with prescribing adherence to GDMT, χ2 (1, N = 981) = 33.36, P < 0.001. Further, WCD use was significantly associated with recommendations for follow-up echocardiographic study, χ2 (1, N = 865) = 66.94, P < 0.001 and use of primary prevention ICD, χ2 (1, N = 1093) = 19.00, P < 0.001. CONCLUSIONS: This study demonstrates the use of the WCD correlates with improved clinician use of GDMT, follow-up echocardiographic studies, and appropriate use of primary prevention ICD. Thus, the potential benefits of the WCD and its care processes may extend beyond prevention of sudden cardiac death to enhanced optimization of GDMT.

Addressing barriers to optimal oral anticoagulation use and persistence among patients with atrial fibrillation: Proceedings, Washington, DC, December 3-4, 2012.

Approximately half of patients with atrial fibrillation and with risk factors for stroke are not treated with oral anticoagulation (OAC), whether it be with vitamin K antagonists (VKAs) or novel OACs (NOACs); and of those treated, many discontinue treatment. Leaders from academia, government, industry, and professional societies convened in Washington, DC, on December 3-4, 2012, to identify barriers to optimal OAC use and adherence and to generate potential solutions. Participants identified a broad range of barriers, including knowledge gaps about stroke risk and the relative risks and benefits of anticoagulant therapies; lack of awareness regarding the potential use of NOAC agents for VKA-unsuitable patients; lack of recognition of expanded eligibility for OAC; lack of availability of reversal agents and the difficulty of anticoagulant effect monitoring for the NOACs; concerns with the bleeding risk of anticoagulant therapy, especially with the NOACs and particularly in the setting of dual antiplatelet therapy; suboptimal time in therapeutic range for VKA; and costs and insurance coverage. Proposed solutions were to define reasons for oral anticoagulant underuse classified in ways that can guide intervention and improve use, to increase awareness of stroke risk as well as the benefits and risks of OAC use via educational initiatives and feedback mechanisms, to better define the role of VKA in the current therapeutic era including eligibility and ineligibility for different anticoagulant therapies, to identify NOAC reversal agents and monitoring strategies and make knowledge regarding their use publicly available, to minimize the duration of dual antiplatelet therapy and concomitant OAC where possible, to improve time in therapeutic range for VKA, to leverage observational data sets to refine understanding of OAC use and outcomes in general practice, and to better align health system incentives.

Performance measures to promote quality improvement in sudden cardiac arrest prevention and treatment.

Sudden cardiac arrest (SCA) is one of the most impactful public health problems in the United States. Despite the progress made in reducing the number of cardiac deaths, the incidence of sudden cardiac death remains high. Studies of life-saving interventions for prevention and treatment of SCA, like ß-blockers, aldosterone antagonists, implantable cardioverter defibrillator therapy, automated external defibrillators, and cardiopulmonary resuscitation, have brought to light substantial underutilization, variations in care, and disparities. Thus, a comprehensive systems-based approach to addressing these gaps in care should be implemented. In addition to educating stakeholders about SCA and its prevention and developing tools that could help physicians identify patients who could benefit from primary prevention of SCA, robust performance measures with strong, evidence-based association between process performance and patient outcomes are needed. In this article, we review the burden of SCA and highlight the need to develop performance measures related to the prevention and treatment of SCA.

Synchronized diaphragmatic stimulation: a case report of a novel extra-cardiac intervention for chronic heart failure.

Synchronized diaphragmatic stimulation (SDS) is a novel extra-cardiac device-based therapy for symptomatic heart failure with reduced ejection fraction. SDS provides imperceptible chronic stimulation of the diaphragm through a laparoscopically implanted system consisting of an implantable pulse generator and two sensing/stimulating leads affixed to the inferior surface of the diaphragm delivering imperceptible R-wave gaited pulses that alter intrathoracic pressure improving ventricular filling and cardiac output. We describe, in a man with a history of myocardial infarctions resulting in heart failure and persistent New York Heart Association Class III symptoms despite standard therapies, the successful implantation of SDS resulting in improved quality of life, N-terminal pro brain natriuretic peptide, cardiac function, and exercise tolerance through 12 months of follow-up. Randomized trials are now required to validate these findings.

Medication adherence for atrial fibrillation patients: triangulating measures from a smart pill bottle, e-prescribing software, and patient communication through the electronic health record.

OBJECTIVE: Our primary objectives were to examine adherence rates across two technologies (e-prescribing software and smart pill bottle) with cross-validation from alert-triggered messaging within the patient electronic health record (EHR) portal and to explore the benefits and challenges faced by atrial fibrillation (AF) patients in using a smart pill bottle. MATERIALS AND METHODS: We triangulated the rate of oral anticoagulant medication adherence among 160 AF patients over 6 months using an EHR in combination with data from the AdhereTech© Wireless Smart Pill Bottle and Surescripts©. In addition, we collected qualitative feedback on patients' Smart Pill Bottle usage through structured interviews with 153 participants. RESULTS: Patients maintained an average adherence rate of 90.0% according to the smart pill bottle; however, when dose misses were calibrated based on patient or provider feedback, the adjusted adherence was 93.6%. Surescripts adherence rates for refills were 92.2%. Participants generally found the bottle easy to operate but suggested that its size and functionality did not fit seamlessly into their existing routine, as many used weekly pill organizers to manage multiple medications. DISCUSSION: Though each method of tracking adherence has positive and negative attributes, combining them and seeking patient feedback may help capture a more accurate adherence rate than any single technological intervention. Technologies may have different design considerations for research and consumer use. CONCLUSION: Overall, these technologies provide useful but imperfect adherence data for research purposes, and smart pill bottles could be improved with patient-centered design. LAY SUMMARY: Medication adherence is very important for those with chronic health issues. For those with heart disease, medication adherence not only offers opportunities for improving quality of life, but it also can be life-saving. Nonetheless, many patients with heart disease, including those with atrial fibrillation (the target group for this study) do not take their medications regularly. As technologies advance, there is unprecedented opportunity to track patients' medication adherence through various methods, which might provide motivation and information to patients as they make daily choices about medication use. In this study, we cross-referenced the results of two of these measures over 6 months-a smart pill bottle, which we used to track pill bottle openings, and e-prescribing software, which we used to track medication refills. We also supplemented these measures with nurse-patient communication via the EHR messaging portal to record exceptions (eg, travel and medication changes) and interviewed patients about their medication use during the 6-month trial. Overall, the tracking technologies worked relatively well to track patient (n = 160) medication behavior; however, they did not capture exceptions. Hence, triangulating data from different sources, with a patient feedback loop, appears critical for gathering accurate data on medication adherence.

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 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.

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.

Achieving Guideline-Directed Heart Rate ControlEarly Posthospitalization.

Guidelines for the treatment of heart failure (HF) recommend the titration of ß blockers (BB) to a target dosage shown to be effective in clinical trials. The benefit of BBs is associated with heart rate (HR) control, with a target resting HR <70 bpm which in clinical trials have been associated with improved clinical outcomes. The primary purpose of this study was to gauge the ability to achieve guideline-directed medical therapy HR control in the early posthospitalization period for HF patients with the wearable cardioverter defibrillator (WCD), assessing whether the WCD could be used to evaluate HR both at rest and during activity to determine if targets were being met and to adequately direct clinical decision making. The WCD platform allows continuous recording of HR. To assess the guideline-directed therapy goals for reduction of resting HR, HR was evaluated both at rest (nighttime: midnight-7 a.m.; daytime: 7 a.m. midnight), and during activity of daily living. HR data during activity of daily living (ADL) and rest were collected from patients with HF that wore the WCD for ≥5 weeks (n = 1,353) between 2015 and 2017. First, 643,891 activity episodes from 1,353 patients were analyzed. Daytime and nighttime resting HRs significantly dropped from beginning to end of WCD use (day: 72.5 bpm vs 69.0 bpm, p <0.0001; night: 68.1 vs 64.3, p <0.0001). However, 43% of patients still had an average daytime resting HR ≥70 bpm during the last week of WCD use. When comparing a patient's peak activity HR during the first week of WCD use to the last week, there was no difference (93.6 bpm vs 94.1 bpm, p = 0.23). During ADL, 31% of patients had a HR ≥100 bpm, 14% of patients had a HR ≥110 bpm, and 6% had a HR ≥120 bpm. In conclusion, months after hospital discharge, 43% of patients did not meet guideline-directed resting target HR control, indicating they may not have been effectively managed with BB. HR during ADL may have also been higher than preferred. Remote HR monitoring may help physicians to adequately titrate guideline-directed medical therapy, thus improving clinical outcomes in HF patients.

Selection biases in technology-based intervention research: patients' technology use relates to both demographic and health-related inequities.

OBJECTIVE: Researchers conduct studies with selection biases, which may limit generalizability and outcomes of intervention research. In this methodological reflection, we examined demographic and health characteristics of implantable cardioverter defibrillator patients who were excluded from an informatics intervention due to lack of access to a computer and/or the internet. MATERIALS AND METHODS: Using information gathered from surveys and electronic health records, we compared the intervention group to excluded patients on demographic factors, computer skills, patient activation, and medical history. RESULTS: Excluded patients were older, less educated, less engaged and activated in their health, and had worse health (ie, more medical comorbidities) than nonexcluded patients. DISCUSSION: Although excluded from the intervention based solely on lack of access to a computer and/or internet, excluded patients may have needed the intervention more because they were sicker with more comorbidities. CONCLUSION: Researchers must be mindful of enrollment biases and demographic and health-related inequities that may exist during recruitment for technology-based interventions.

Teens Using Screens for Help: Impact of Suicidal Ideation, Anxiety, and Depression Levels on Youth Preferences for Telemental Health Resources.

BACKGROUND: High rates of mental illness, stress, and suicidality among teens constitute a major public health concern in the United States. However, treatment rates remain low, partially because of barriers that could be mitigated with tech-based telemental health (TMH) resources, separate from or in addition to traditional care. OBJECTIVE: This study aimed to analyze TMH resource usage by high school students to establish current user characteristics and provide a framework for future development. METHODS: A total of 2789 students were surveyed regarding demographics, recent anxiety and depression symptoms, suicidality, and stress; people with whom they could openly and honestly discuss stress or problems, and prior TMH use. Logistic regression models and a general linear model were used to test relationships between variables. RESULTS: Overall, 30.58% (853/2789) and 22.91% (639/2789) of students reported moderate to severe anxiety and depression symptoms, respectively, in the past 2 weeks; 16.24% (414/2550) had seriously considered suicide in the past year, consistent with national averages. Meanwhile, 16.03% (447/2789) of students had previously used at least 1 of 4 types of TMH resources (ie, self-help, anonymous chat, online counselor, or crisis text line). Teens reporting depression symptoms, higher stress, or suicidality were less likely to talk to a parent about stress or problems and more likely to tell no one. Suicidality was related to the use of all 4 types of TMH resources. Depression symptoms were related to the use of anonymous chat and crisis text line, and those with higher stress were more likely to have used an online counselor. Those reporting anxiety symptoms were less likely to have no one to talk to and more likely to have used a self-help resource. CONCLUSIONS: Youth struggling with mental health symptoms, some of whom lack real-life confidants, are using existing TMH support, with resource preferences related to symptoms. Future research should consider these preferences and assist in the creation of specialized, evidence-based TMH resources.

The Use of Electronic Personal Health Records to Improve Medication Adherence and Patient Engagement: A Randomized Study of Non-valvular Atrial Fibrillation Patients.

Embolic stroke is a major complication of atrial fibrillation (AF) that frequently results in disability or death. The administration of oral anticoagulation can reduce stroke risk in AF patients; however, medication non-adherence can eliminate this benefit. To date, reported patient adherence rates to oral anticoagulation regimens vary. The objective of the current study was to examine the impact of medication-specific education delivered via a personal health record (PHR) system on medication adherence. A randomized, prospective study was conducted from February 2014 to June 2014 at Parkview Health, a not-for-profit, community-based health care clinic that serves a northeastern Indiana population of more than 820,000. AF patients receiving dabigatran (Pradaxa®; Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany) to prevent stroke participated in this study. The study participants were predominantly Caucasian males over 65 years of age who were educated, insured, and living above the poverty level. Patients were allowed to view online, download, and transmit health information via a PHR. The intervention group received PHR training and dabigatran education via the PHR. The control group received standard care and PHR access without training. A longitudinal survey pertaining to medication knowledge, medication adherence, and patient engagement was administered at baseline and at the end of the study. Medication-dispensing data collected from pharmacy refill prescriptions were used for calculating the medication possession ratio (MPR). Ninety patients were included in this study, and were randomly assigned to either the intervention group (n = 46) or the control group (n = 44). All participants completed the baseline survey, and 95.6% of patients finished the follow-up survey. The mean score for knowledge increased significantly in the intervention group (from 3.77 to 4.23, p = 0.005), but not in the control group (from 3.70 to 3.95, p = 0.72). The MPR was significantly higher in the intervention group (97.47% vs. 87.67%, p = 0.001). Both groups had similar levels of improvement in Patient Activation Measure scores (from 63.0 to 65.8, p = 0.078 vs. from 63.1 to 63.6, p = 0.814). Patients who used the PHR achieved greater medication knowledge, resulting in improved medication adherence. To our knowledge, no published randomized trial has reported on the use of PHRs to improve medication adherence and knowledge. This study is the first to demonstrate a positive impact on anticoagulation adherence with PHR use.

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.

Developing a risk model for in-hospital adverse events following implantable cardioverter-defibrillator implantation: a report from the NCDR (National Cardiovascular Data Registry).

OBJECTIVES: To better inform patients and physicians of the expected risk of adverse events and to assist hospitals' efforts to improve the outcomes of patients undergoing implantable cardioverter-defibrillator (ICD) implantation, we developed and validated a risk model using data from the NCDR (National Cardiovascular Data Registry) ICD Registry. BACKGROUND: ICD prolong life in selected patients, but ICD implantation carries the risk of periprocedural complications. METHODS: We analyzed data from 240,632 ICD implantation procedures between April 1, 2010, and December 31, 2011 in the registry. The study group was divided into a derivation (70%) and a validation (30%) cohort. Multivariable logistic regression was used to identify factors associated with in-hospital adverse events (complications or mortality). A parsimonious risk score was developed on the basis of beta estimates derived from the logistic model. Hierarchical models were then used to calculate risk-standardized complication rates to account for differences in case mix and procedural volume. RESULTS: Overall, 4,388 patients (1.8%) experienced at least 1 in-hospital complication or death. Thirteen factors were independently associated with an increased risk of adverse outcomes. Model performance was similar in the derivation and validation cohorts (C-statistics = 0.724 and 0.719, respectively). The risk score characterized patients into low- and-high risk subgroups for adverse events (≤10 points, 0.3%; ≥30 points, 4.2%). The risk-standardized complication rates varied significantly across hospitals (median: 1.77, interquartile range 1.54, 2.14, 5th/95th percentiles: 1.16/3.15). CONCLUSIONS: We developed a simple model that predicts risk for in-hospital adverse events among patients undergoing ICD placement. This can be used for shared decision making and to benchmark hospital performance.