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Introduction: Global interest is growing in new value-based models of financing, delivering, and paying for health care services that could produce higher-quality and lower cost outcomes for patients and for society. However, research indicates evidence gaps in knowledge related to alternative payment models (APMs) in early experimentation phases or those contracted between private insurers and their health care provider-partners. The aim of this research was to understand and update the literature related to learning how industry experts design and implement APMs, including specific elements of their models and their choice of stakeholders to be involved in the design and contractual details. Methods: A literature review was conducted to guide the research focus and to select themes. The sample was selected using snowball sampling to identify subject matter experts (SMEs). Researchers conducted 16 semi-structured interviews with SMEs in the US, the Netherlands, and Germany in September and October 2021. Interviews were transcribed and using Braun and Clarke's six-phase approach to thematic analysis, researchers independently read, reviewed, and coded participants' responses related to APM design and implementation and subsequently reviewed each other's codes and themes for consistency. Results: Participants represented diverse perspectives of the payer, provider, consulting, and government areas of the health care sector. We found design considerations had five overarching themes: (1) population and scope of care and services, (2) benchmarking, metrics, data, and technology; (3) finance, APM type, risk adjustment, incentives, and influencing provider behavior, (4) provider partnerships and the role of physicians, and (5) leadership and regulatory issues. Discussion: This study confirmed several of the core components of APM model designs and implementations found in the literature and brought insights on additional aspects not previously emphasized, particularly the role of physicians (especially in leadership) and practice transformation/care processes necessary for providers to thrive under APM models. Importantly, researchers found significant concerns relevant for policymakers about regulations relating to health data sharing, rigid price-setting, and inter-organizational data communication that greatly inhibit the ability to experiment with APMs and those models' abilities to succeed long-term.

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BACKGROUND: Following the Centers for Medicare and Medicaid Services' approval of the Acute Hospital Care at Home waiver, an increasing number of health care organizations launched Home Hospital (HH) programs in the USA. Ongoing barriers include access to HH expertise and a standard, comprehensive set of implementation tools. We created the HH Early Adopters Accelerator to bring together a network of health care organizations to develop tools ("knowledge products") necessary for HH implementation. OBJECTIVE: To demonstrate the feasibility of the Accelerator approach for generating and implementing relevant, high-quality knowledge products. DESIGN: Mixed methods evaluation of the Accelerator. Surveys and qualitative interviews of Accelerator participants were conducted. Surveys elicited feedback on the knowledge products, including time spent on development, perceived utility and quality, and implementation success. The qualitative interviews gathered more in-depth information on topics covered in the surveys. PARTICIPANTS: Eighteen healthcare organizations and 105 individuals participated in the Accelerator. KEY RESULTS: The Accelerator reached its goal and developed 20 knowledge products in 32 working weeks (more efficient than expected). Participants agreed that the knowledge products were useful (developers: 98.1%; stakeholders: 93.8%), of high quality (developers: 96.8%), and would improve patient care if implemented in their HH program (developers: 91.7%; stakeholders: 91.2%). Two thirds (66.7%) of the participating organizations who had implemented knowledge products at 3 months continued utilizing knowledge products in their HH program at 1 year. Agreement that knowledge products improve patient care persisted (92% strongly agreed or agreed) at 1 year. Several programs created new tools, policies, and workflows as a result of implementing the knowledge products. CONCLUSIONS: The Accelerator created high-quality, comprehensive knowledge products that healthcare organizations found useful for safe HH implementation 1 year later. The Accelerator approach can feasibly help healthcare organizations safely bridge the gap between innovation and standard practice.

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BACKGROUND: Birthing people with de novo postpartum hypertensive disorders continue to be among the populations at highest risk for severe maternal morbidity. Randomized controlled trials demonstrate a benefit of oral loop diuretics in decreasing postpartum hypertensive morbidity in patients with an antenatal diagnosis of preeclampsia. It is not known whether this same therapy benefits patients at risk for new-onset postpartum hypertension. OBJECTIVE: This study aimed to evaluate whether oral furosemide can reduce the risk for de novo postpartum hypertension among high-risk birthing people by reducing postdelivery blood pressure. STUDY DESIGN: From October 2021 to April 2022, we conducted a randomized triple-masked placebo-controlled clinical trial of individuals at high risk for de novo postpartum hypertension at a single university-based tertiary care medical center. A total of 82 postpartum patients with no antenatal diagnosis of chronic hypertension or a hypertensive disorder of pregnancy who were at high risk for the development of de novo postpartum hypertension based on a prespecified risk factor algorithm were enrolled after childbirth. The participants were randomly assigned in a 1:1 ratio to a 5-day course of 20-mg oral furosemide daily or identical-appearing placebo starting within 8 hours of delivery. Participants were followed for 6 weeks postpartum using Bluetooth-enabled remote blood pressure monitoring and electronic surveys. The primary outcome was mean arterial pressure averaged over the 24 hours before discharge or the 24 hours before antihypertensive therapy initiation. The study was powered to detect a 5 mm Hg difference in average mean arterial pressure (standard deviation, 6.4 mm Hg) with 90% power at an alpha of 0.05, requiring a sample size of 41 per group. Secondary outcomes included the rate of de novo postpartum hypertension, readmission data, other measures of hypertensive and maternal morbidity, breastfeeding data, and drug-related neonatal outcomes. RESULTS: The primary outcome was assessed in 80 of the 82 participants. Baseline characteristics were similar between the groups. There was no significant difference in average mean arterial pressure in the 24 hours before discharge (or antihypertensive initiation) in the furosemide group (88.9±7.4 mm Hg) compared with the placebo group (86.8±7.1 mm Hg; absolute difference, 2.1 mm Hg; 95% confidence interval, -1.2 to 5.3). Of the 79 participants for whom secondary outcomes were assessed, 10% (n=8) developed de novo postpartum hypertension and 9% (n=7) were initiated on antihypertensive therapy. Rates were not significantly different between the groups (P=.71 and P>.99, respectively). CONCLUSION: De novo postpartum hypertension is a common phenomenon among at-risk patients, warranting close monitoring for severe hypertension and other maternal morbidity. There is insufficient evidence to suggest that furosemide reduces average mean arterial pressure in the 24 hours before discharge from the delivery hospitalization (or antihypertensive medication initiation) compared with placebo.

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BACKGROUND: Consumer wearable devices with health and wellness features are increasingly common and may enhance disease detection and management. Yet studies informing relationships between wearable device use, attitudes toward device data, and comprehensive clinical profiles are lacking. METHODS AND RESULTS: WATCH-IT (Wearable Activity Tracking for Comprehensive Healthcare-Integrated Technology) studied adults receiving longitudinal primary or ambulatory cardiovascular care in the Mass General Brigham health care system from January 2010 to July 2021. Participants completed a 20-question electronic survey about perceptions and use of consumer wearable devices, with responses linked to electronic health records. Multivariable logistic regression was used to identify factors associated with device use. Among 214 992 individuals receiving longitudinal primary or cardiovascular care with an active electronic portal, 11 121 responded (5.2%). Most respondents (55.8%) currently used a wearable device, and most nonusers (95.3%) would use a wearable if provided at no cost. Although most users (70.2%) had not shared device data with their doctor previously, most believed it would be very (20.4%) or moderately (34.4%) important to share device-related health information with providers. In multivariable models, older age (odds ratio [OR], 0.80 per 10-year increase [95% CI, 0.77-0.82]), male sex (OR, 0.87 [95% CI, 0.80-0.95]), and heart failure (OR, 0.75 [95% CI, 0.63-0.89]) were associated with lower odds of wearable device use, whereas higher median income (OR, 1.08 per 1-quartile increase [95% CI, 1.04-1.12]) and care in a cardiovascular medicine clinic (OR, 1.17 [95% CI, 1.05-1.30]) were associated with greater odds of device use. CONCLUSIONS: Among patients in primary and cardiovascular medicine clinics, consumer wearable device use is common, and most users perceive value in wearable health data.

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In 2021, the rapid rise in COVID-19 infections put overwhelming demand on health care services. It was recognised that patients could be managed in the community if an appropriate monitoring service existed. Medical students were recruited for roles that combined technology, teamwork and clinical skills. This is an example of how novel roles can provide solutions in times of health care crises.

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Artificial intelligence (AI) is becoming an indispensable tool to augment decision making in different health care settings and by various members of the patient pathway, including the patient. AI provides the ability to optimize data to bring clinical decision support for clinicians and laboratorians and/or empower patients to actively participate in their own health care. Though there are many examples of AI in health care, the exact role of AI and digital health solutions is still taking shape. Although AI will not replace the clinician, those who do not adopt AI may in time, be left behind.

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BACKGROUND: Innovation and entrepreneurship training are increasingly recognized as being important in medical education. However, the lack of faculty comfort with the instruction of these concepts as well as limited scholarly recognition for this work has limited the implementation of curricula focused on these skills. Furthermore, this lack of familiarity limits the inclusion of practicing physicians in health care innovation, where their experience is valuable. Hackathons are intense innovation competitions that use gamification principles to increase comfort with creative thinking, problem-solving, and interpersonal collaboration, but they require further exploration in medical innovation. OBJECTIVE: To address this, we aimed to design, implement, and evaluate a health care hackathon with 2 main goals: to improve emergency physician familiarity with the principles of health care innovation and entrepreneurship and to develop innovative solutions to 3 discrete problems facing emergency medicine physicians and patients. METHODS: We used previously described practices for conducting hackathons to develop and implement our hackathon (HackED!). We partnered with the American College of Emergency Physicians, the Stanford School of Biodesign, and the Institute of Design at Stanford (d.school) to lend institutional support and expertise in health care innovation to our event. We determined a location, time frame, and logistics for the competition and settled on 3 use cases for teams to work on. We planned to explore the learning experience of participants within a pragmatic paradigm and complete an abductive thematic analysis using data from a variety of sources. RESULTS: HackED! took place from October 1-3, 2022. In all, 3 teams developed novel solutions to each of the use cases. Our investigation into the educational experience of participants suggested that the event was valuable and uncovered themes suggesting that the learning experience could be understood within a framework from entrepreneurship education not previously described in relation to hackathons. CONCLUSIONS: Health care hackathons appear to be a viable method of increasing physician experience with innovation and entrepreneurship principles and addressing complex problems in health care. Hackathons should be considered as part of educational programs that focus on these concepts.

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OBJECTIVE: The current study aimed to evaluate the satisfaction level of parents from telemedicine use in the long-term follow-up of children operated for craniosynostosis during the COVID-19 pandemic. DESIGN: A cross-sectional 9-question survey analysis using Qualtrics survey software. SETTING: An institutional study carried out at a national, tertiary level academic center in the Slovak Republic. PATIENTS: All patients operated for non-syndromic and syndromic craniosynostosis in our department, who participated in the virtual postoperative follow-up consultations from March 23, 2020, through July 2, 2021, were included in our series. They were enrolled 498 patients, with the parents of 256 children being responding to the survey. INTERVENTIONS: The survey remained open until July 16, 2021, two weeks after the last virtual consultations. It was delivered to the parents by e-mail to generate closed 5-point Likert scale responses. RESULTS: Overall, 72.3% of parents were satisfied with the telemedicine program, and 67.2% found it convenient. Collectively, 89.1% reported that the received instructions were helpful to them. However, only 18.7% of them answered that they would prefer telemedicine consultations in the future. CONCLUSION: The results of this study showed a high satisfaction from the parents during the virtual follow-up of children operated for craniosynostosis. However, despite their positive experience with telemedicine, the vast majority of parents stated that they would prefer in-person visits in the future.

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The chapter summarizes key literature, including emerging ideas, that is pertinent to the question of how organizations and their leadership deal with and are resilient through crises - highlighting what works in surviving unexpected crises. The chapter presents an illustration of organizational response; it concludes with an analysis of what is missing from the literature and recommends a path forward to expanding actionable knowledge in this area. Multiple, interdependent factors that foster resilience are identified including (1) being sensitive to possible threats - even seemingly small failures, (2) not relying on simple interpretations of events but rather seeking diversity to create a complete view of the environment, (3) leadership that embraces communication, transparency, and continuous learning, (4) valuing expertise and allowing expert staff to make decisions during a crisis, and (5) a cultural commitment to a resiliency mindset that accepts failures as opportunities to learn and improve. Emerging concepts that may foster resilience but require more research include managing paradox, emotional ambivalence and diversity. Additional areas for fruitful research include: the impact of short-term versus long-term, or successive, crises; external versus internal shocks and the framing of the source of shocks; how crisis affect the pace of innovation and change; the role of diversity in organizational responses to crises; and a set of methodological opportunities to leverage natural experiments or simulations in ways that allow for longitudinal data illuminating the full cycle of crises across organizations from anticipation, to response, to longer-term adaptation to the new normal.

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BACKGROUND: Designing implementation programs that effectively integrate complex healthcare innovations into complex settings is a fundamental aspect of knowledge translation. We describe the development of a conceptually grounded implementation program for a complex healthcare innovation and its subsequent application in pediatric hospital settings. METHODS: We conducted multiple case observations of the application of the Phased Reciprocal Implementation Synergy Model (PRISM) framework in the design and operationalization of an implementation program for a complex hospital wide innovation in pediatric hospital settings. RESULTS: PRISM informed the design and delivery of 10 international hospital wide implementations of the complex innovation, BedsidePEWS. Implementation and innovation specific goals, overarching implementation program design principles, and a phased-based, customizable, and context responsive implementation program including innovation specific tools and evaluation plans emerged from the experience. CONCLUSION: Theoretically grounded implementation approaches customized for organizational contexts are feasible for the adoption and integration of this complex hospital-wide innovation. Attention to the fitting of the innovation to local practices, setting, organizational culture and end-user preferences can be achieved while maintaining the integrity of the innovation.

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Health systems internationally must prepare for a future of genetic/genomic testing to inform healthcare decision-making while creating research opportunities. High functioning testing services will require additional considerations and health system conditions beyond traditional diagnostic testing. Based on a literature review of good practices, key informant interviews, and expert discussion, this article attempts to synthesize what conditions are necessary, and what good practice may look like. It is intended to aid policymakers and others designing future systems of genome-based care and care prevention. These conditions include creating communities of practice and healthcare system networks; resource planning; across-region informatics; having a clear entry/exit point for innovation; evaluative function(s); concentrated or coordinated service models; mechanisms for awareness and care navigation; integrating innovation and healthcare delivery functions; and revisiting approaches to financing, education and training, regulation, and data privacy and security. The list of conditions we propose was developed with an emphasis on describing conditions that would be applicable to any healthcare system, regardless of capacity, organizational structure, financing, population characteristics, standardization of care processes, or underlying culture.

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Augmented Intelligence (AI) systems have the power to transform health care and bring us closer to the quadruple aim: enhancing patient experience, improving population health, reducing costs, and improving the work life of health care providers. Earning physicians' trust is critical for accelerating adoption of AI into patient care. As technology evolves, the medical community will need to develop standards for these innovative technologies and re-visit current regulatory systems that physicians and patients rely on to ensure that health care AI is responsible, evidence-based, free from bias, and designed and deployed to promote equity. To develop actionable guidance for trustworthy AI in health care, the AMA reviewed literature on the challenges health care AI poses and reflected on existing guidance as a starting point for addressing those challenges (including models for regulating the introduction of innovative technologies into clinical care).

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The case study design is particularly useful for implementation analysis of complex health care innovations in primary care that can be influenced by the context of dynamic environments. Case studies may be combined with participatory approaches where academics conduct joint research with nonacademic stakeholders, to foster translation of findings results into practice. The aim of this article is to clarify epistemological and methodological considerations of case studies with a participatory approach. It also aims to propose best practice recommendations when using this case study approach. We distinguish between the participatory case study with full co-construction and co-governance, and the case study with a participatory approach whereby stakeholders are consulted in certain phases of the research. We then compare the epistemological posture of 3 prominent case study methodologists, Yin, Stake, and Merriam, to present the epistemological posture of case studies with a participatory approach. The relevance, applications, and procedures of a case study with a participatory approach methodology are illustrated through a concrete example of a primary care research program (PriCARE). We propose 12 steps for designing and conducting a case study with a participatory approach that may help guide researchers in the implementation analysis of complex health care innovations in primary care.

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BACKGROUND: During the first peak of the COVID-19 pandemic in the Netherlands, relatives of patients with COVID-19 admitted to Intensive Care Units (ICUs) were severely restricted in visiting their relatives and in communicating with treating physicians. Family communication is a core element of critical care, however, this pandemic forced medical ICU staff to arrange alternative family support for instance by Family Support Teams (FSTs), consisting of non-ICU affiliated staff who telephonically contacted relatives. This study aims to examine relatives' experiences with FSTs on two ICUs of a Dutch university medical centre, and to evaluate its working strategies. . METHODS: In a semi-structured interview study, relatives of patients with COVID-19 admitted to ICU's, who had been supported by the FSTs, were sampled purposively. Twenty-one interviews were conducted telephonically by three researchers. All interviews were topic list guided and audio-recorded. Data was analysed thematically. RESULTS: All participants indicated they went through a rough time. Almost all evaluated the FSTs positively. Four major themes were identified. First, three important pillars of the FSTs were providing relatives with transparency about the patients' situation, providing attention to relatives' well-being, and providing predictability and certainty by calling on a daily basis in a period characterised by insecurity. Second, relatives appeared to fulfil their information needs by calls of the FSTs, but also by calling the attending ICU nurse. Information provided by the FSTs was associated with details and reliability, information provided by nurses was associated with the patient's daily care. Third, being a primary family contact was generally experienced as both valuable and as an emotional burden. Last, participants missed proper aftercare. Family support often stopped directly after the patient died or had left the ICU. Relatives expressed a need for extended support after that moment since they had strong emotions after discharge or death of the patient. CONCLUSIONS: Family support in times of the extreme COVID-19 situation is important, as relatives are restricted in communication and have a strong need for information and support. Relatives feel encouraged by structure, frequency, support and understanding by FSTs. However, remote family support should be tailored to the needs of relatives. A fixed contact person on de ICU and video calling might be good extra options for family support, also in future post COVID-19 care, but cannot replace physical visits.

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Aim: The aim was to gain insight in the preferences of people with type 2 diabetes mellitus regarding the moments and methods of patient participation in the development and application of eHealth, and which factors influence this. Methods: A digital questionnaire with both closed and open questions was distributed via various online platforms and the newsletter of the Diabetes Association in the Netherlands. Information was collected on: 1) willingness to participate; 2) preferences about the method of participation; 3) influencing factors on participation, including motivation, competence, resources, social influences, and outcome expectations; 4) background characteristics. Results: 160 questionnaires were analysed. More than three quarter of the respondents intend to be involved in patient participation. Most respondents prefer solo participation methods over group participation, respectively 93% and 46%. Half of the respondents feel that they have sufficient knowledge to participate, and 40% feels that they can provide valuable input. As compensation for participation, participants prefer to use new technologies for free. Conclusion: As people with diabetes type 2 differ in their preferences for moments and methods of participation, it is recommended to offer different methods of participation and types of compensation in the process from development to application of eHealth.

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Innovative, patient-centered, and pragmatic dialysis technologies are urgently needed to accommodate the growing national interest in home dialysis use. To help achieve this goal, the US Centers for Medicare & Medicaid Services (CMS) are expanding reimbursement for eligible home dialysis machines through an existing payment mechanism, the transitional add-on payment for new and innovative equipment and supplies (TPNIES). This mechanism incentivizes the early adoption of innovative equipment into practice by reimbursing dialysis providers up to 26% of the total cost of approved home dialysis machines. Machines are evaluated for TPNIES eligibility using prespecified substantial clinical improvement (SCI) criteria that are derived from the Inpatient Prospective Payment System (for non-nephrology technologies). Although the SCI criteria may be suitable for some non-nephrology technologies, they have not been adapted to consider the unique and complex care inherent in home dialysis. Thus, many of the SCI criteria appear unsuitable for home dialysis machines. To better incentivize innovation, CMS should develop nephrology-specific transparent and pragmatic criteria for TPNIES. In this perspective, we provide an overview of the TPNIES payment mechanism, highlight areas of concern within the policy, and offer solutions for improving TPNIES that could better promote the adoption of new home dialysis machines.

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The Mount Sinai Hospital in New York City was in the epicenter of the COVID-19 pandemic and had to transform from a tertiary to crisis care hospital and increase its bed capacity by 50 percent to care for COVID-19 patients. The size, scope, complexity and uncertainty of this crisis was unparalleled. This article describes the comprehensive response of the Department of Social Work Services, one of the largest hospital social work departments in the country. The response was informed by four Departmental principles, as well as crisis intervention strategies. This article describes organizational structures, practice models, policies, and protocols developed to respond quickly and effectively, given infection prevention mandates, to patient, population and workforce needs. Finally, it includes how social workers addressed COVID-19 related physical and psychosocial needs and applied and modified interprofessional communication and collaboration. Lessons learned and clinical and administrative changes that will assist in navigating "new normal" operations are discussed.

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BACKGROUND: Ascites is a common, painful, and serious complication of cirrhosis. Body weight is a reliable proxy for ascites volume; therefore, daily weight monitoring is recommended to optimize ascites management. OBJECTIVE: This study aims to evaluate the feasibility of a smartphone app in facilitating outpatient ascites management. METHODS: In this feasibility study, patients with cirrhotic ascites requiring active management were identified in both inpatient and outpatient settings. Patients were provided with a Bluetooth-connected scale, which transmitted weight data to a smartphone app and then via the internet to an electronic medical record (EMR). Weights were monitored every weekday. In the event of a weight change of ≥5 lbs in 1 week, patients were called and administered a short symptom questionnaire, and providers received an email alert. The primary outcomes of this study were the percentage of enrolled days during which weight data were successfully transmitted to an EMR and the percentage of weight alerts that prompted responses by the provider. RESULTS: In this study, 25 patients were enrolled: 12 (48%) were male, and the mean age was 58 (SD 13; range 35-81) years. A total of 18 (72%) inpatients were enrolled. Weight data were successfully transmitted to an EMR during 71.2% (697/979) of the study enrollment days, with technology issues reported on 16.5% (162/979) of the days. Of a total of 79 weight change alerts fired, 41 (52%) were triggered by weight loss and 38 (48%) were by weight gain. Providers responded in some fashion to 66 (84%) of the weight alerts and intervened in response to 45 (57%) of the alerts, for example, by contacting the patient, scheduling clinic or paracentesis appointments, modifying the diuretic dose, or requesting a laboratory workup. Providers responded equally to weight increase and decrease alerts (P=.87). The staff called patients a mean of 3.7 (SD 3.5) times per patient, and the number of phone calls correlated with technology issues (r=0.60; P=.002). A total of 60% (15/25) of the patients chose to extend their participation beyond 30 days. A total of 17 patient readmissions occurred during the study period, with only 4 (24%) related to ascites. CONCLUSIONS: We demonstrated the feasibility of a smartphone app to facilitate the management of ascites and reported excellent rates of patient and provider engagement. This innovation could enable early therapeutic intervention, thereby decreasing the burden of morbidity and mortality among patients with cirrhosis.

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Occasional bursts of discovery and innovation have appeared during the otherwise stagnant past several decades of drug development in nephrology. Among other recent drug discoveries, the unexpected kidney benefits observed with sodium/glucose cotransporter 2 inhibitors may herald a renaissance of drug development in kidney disease. This recent progress highlights the need to further promote and stimulate research and development of promising therapies that may ameliorate the morbidity and mortality associated with kidney disease. To help identify and address barriers to drug development in nephrology, the Duke Clinical Research Institute convened a conference in April 2019 that included stakeholders from academia, industry, government agencies, and patient advocacy. From these discussions, several opportunities were identified to improve every stage of drug development for kidney disease from early discovery to implementation into practice. Key topics reviewed in this article are the utility of interconnected data and site research networks, surrogate end points, pragmatic and adaptive trial designs, the promising uses of real-world data, and methods to improve the generalizability of trial results and uptake of approved drugs for kidney-related diseases.

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