Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial.

BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline-recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally designed gamification, loss-framed financial incentives, or their combination on physical activity compared with attention control over 12-month intervention and 6-month postintervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical atherosclerotic cardiovascular disease or a 10-year risk of myocardial infarction, stroke, or cardiovascular death of ≥7.5% by the Pooled Cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n=151), behaviorally designed gamification (n=304), loss-framed financial incentives (n=302), or gamification+financial incentives (n=305). The primary outcome of the trial was the change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean±SD age, 67±8; 61% female; 31% non-White) were enrolled. Compared with control subjects, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0 [95% CI, 186.2-889.9]; P=0.0027), financial incentives arm (adjusted difference, 491.8 [95% CI, 139.6-844.1]; P=0.0062), and gamification+financial incentives arm (adjusted difference, 868.0 [95% CI, 516.3-1219.7]; P<0.0001). During the 6-month follow-up, physical activity remained significantly greater in the gamification+financial incentives arm than in the control arm (adjusted difference, 576.2 [95% CI, 198.5-954]; P=0.0028), but it was not significantly greater in the gamification (adjusted difference, 459.8 [95% CI, 82.0-837.6]; P=0.0171) or financial incentives (adjusted difference, 327.9 [95% CI, -50.2 to 706]; P=0.09) arms after adjustment for multiple comparisons. CONCLUSIONS: Behaviorally designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification+financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT03911141.

The Emergence and Global Spread of Noninvasive Prenatal Testing.

Since its introduction in 2011, noninvasive prenatal testing (NIPT) has spread rapidly around the world. It carries numerous benefits but also raises challenges, often related to sociocultural, legal, and economic contexts. This article describes the implementation of NIPT in nine countries, each with its own unique characteristics: Australia, Canada, China and Hong Kong, India, Israel, Lebanon, the Netherlands, the United Kingdom, and the United States. Themes covered for each country include the structure of the healthcare system, how NIPT is offered, counseling needs and resources, and cultural and legal context regarding disability and pregnancytermination. Some common issues emerge, including cost as a barrier to equitable access, the complexity of decision-making about public funding, and a shortage of appropriate resources that promote informed choice. Conversely, sociocultural values that underlie the use of NIPT vary greatly among countries. The issues described will become even more challenging as NIPT evolves from a second-tier to a first-tier screening test with expanded use.

Qualitative analysis of a remote monitoring intervention for managing heart failure.

BACKGROUND: Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. OBJECTIVE: The goal was to explore patient and clinician perceptions of the program and its impact on perceived health outcomes and better understand why some patients or clinicians did better or worse than others in response to the intervention. APPROACH: This was a retrospective qualitative study utilizing semi-structured interviews with 43 patients and 16 clinicians to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. KEY RESULTS: Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. CONCLUSION: Our qualitative analysis indicates potential areas for additional exploration and consideration to design better behavioral economic interventions to improve cardiovascular health outcomes for patients with HF. Patients appreciated lottery incentives for adhering to program requirements; however, many were too far along in their disease progression to benefit from the intervention. Clinicians found the amount and frequency of electronic alerts burdensome and felt they did not improve patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02708654.

Patient perspectives on states worse than death: A qualitative study with implications for patient-centered outcomes and values elicitation.

BACKGROUND: Seriously ill patients rate several health outcomes as states worse than death. It is unclear what factors underlie such valuations, and whether consideration of such states is useful when making medical decisions. AIM: We sought to (1) use qualitative approaches to identify states worse than death, (2) identify attributes common to such undesirable health states, and (3) determine how participants might use information on these states in making medical decisions. DESIGN: Qualitative study of semi-structured interviews utilizing content analysis with constant comparison techniques. SETTING, PARTICIPANTS: We interviewed adults age 65 or older with serious illnesses after discharge home from one of two urban, academic hospitals. Eligible patients were purposively sampled to achieve balance in gender and race. RESULTS: Of 29 participants, 15 (52%) were female, and 15 were white (52%), with a median age of 72 (interquartile range 69, 75). Various physical, cognitive, and social impairments were identified as states worse than death. The most commonly reported attributes underlying states worse than death were perceived burden on loved ones and inability to maintain human connection. Patients believed information on states worse than death must be individualized, and were concerned their opinions could change with time and fluctuations in health status. CONCLUSIONS: Common factors underlying undesirable states suggest that for care to be patient-centered it must also be family-centered. Patients' views on using states worse than death in decision making highlight barriers to using avoidance of such states as a quality measure, but also suggest opportunities for eliciting patients' values.

Caring for older patients with advanced chronic kidney disease and considering their needs: a qualitative study.

BACKGROUND: Older patients with advanced chronic kidney disease often do not understand treatment options for renal replacement therapy, conservative kidney management, and advance care planning. It is unclear whether both clinicians and patients have similar perspectives on these treatments and end-of-life care. Thus, the aim of this study was to explore clinician and patient/caregiver perceptions of treatments for end-stage renal disease and advance care planning. METHODS: This was a qualitative interview study of nephrologists (n = 8), primary care physicians (n = 8), patients (n = 10, ≥ 65 years and estimated glomerular filtration rate < 20), and their caregivers (n = 5). Interviews were conducted until thematic saturation was reached. Transcripts were transcribed using TranscribeMe. Using Nvivo 12, we identified key themes via narrative analysis. RESULTS: We identified three key areas in which nephrologists', primary care physicians', and patients' expectations and/or experiences did not align: 1) dialysis discussions; 2) dialysis decision-making; and 3) processes of advance care planning. Nephrologist felt most comfortable specifically managing renal disease whereas primary care physicians felt their primary role was to advocate for patients and lead advance care planning discussions. Patients and caregivers had many concerns about the impact of dialysis on their lives and did not fully understand advance care planning. Clinicians' perspectives were aligned with each other but not with patient/caregivers. CONCLUSIONS: Our findings highlight the differences in experiences and expectations between clinicians, patients, and their caregivers regarding treatment decisions and advance care planning. Despite clinician agreement on their responsibilities, patients and caregivers were unclear about several aspects of their care. Further research is needed to test feasible models of patient-centered education and communication to ensure that all stakeholders are informed and feel engaged.

Pandora's pregnancy: NIPT, CMA, and genome sequencing-A new era for prenatal genetic testing.

OBJECTIVES: We delineate in this article a shift from the "traditional" technologies of karyotyping in PND to the current phase of advanced genetic technologies including noninvasive prenatal testing (NIPT), chromosomal microarray analysis (CMA), and whole-exome sequencing (WES) with their higher detection rate and related abundance of uncertain data. METHODS: Conceptual analysis based on seminal works that shaped the socioethical discourse surrounding the experiences of parents as well as professionals with prenatal diagnosis in the last 30 years. RESULTS: We consider the implications of this new era of PND for patients and health professionals by drawing on previous studies documenting how probability and uncertainty affect informed consent/choice, health risks communication, customer satisfaction and decision making, and parent-child bonding. CONCLUSIONS: We argue that these changes move us beyond the idioms and realities of the tentative pregnancy and moral pioneering, to uncertainty, probability-based counseling, and moral/translational gambling. We conclude by discussing what is needed to maintain hope in the era of Pandora's pregnancy.

Attitudes of Israeli parents of children with Down syndrome toward non-invasive prenatal screening and the scope of prenatal testing.

Due to its early utilization and increasing ability to provide genetic information, non-invasive prenatal screening (NIPS) has reinforced social and bioethical quandaries concerning prenatal genetics. This paper presents exploratory findings based on 20 semi-structured interviews conducted in 2017-2019 with Israeli parents of children with Down syndrome (DS), four of whom also serving as representatives of DS organizations. Their views are presented regarding the pros and cons of NIPS; the social context of decision-making about NIPS; and views on life with DS and termination of pregnancies on that ground. While illustrating the large heterogeneity of views concerning NIPS and prenatal diagnosis (PND) amongst parents of children with DS, our respondents commonly criticized the imbalanced information provided by professionals regarding DS, seen as sending a discriminating message in line with the public ignorance surrounding DS. These views are further discussed in the multi-cultural, ableist and pro-natal context of Israeli society. We conclude by offering practical implications concerning NIPS, parental autonomy, and informed choice.

Using a positive deviance framework to identify Local Health Departments in Communities with exceptional maternal and child health outcomes: a cross sectional study.

BACKGROUND: The United States spends more than most other countries per capita on maternal and child health (MCH), and yet lags behind other countries in MCH outcomes. Local health departments (LHDs) are responsible for administering various maternal and child health programs and interventions, especially to vulnerable populations. The goal of this study was to identify local health department jurisdictions (LHDs) that had exceptional maternal and child health outcomes compared to their in-state peers - positive deviants (PDs) - in Washington, Florida and New York in order to support the identification of strategies that can improve community health outcomes. METHODS: We used MCH expenditure data for all LHDs in FL (n = 67), and WA (n = 35), and most LHDs in NY (n = 48) for 2009-2010 from the Public Health Activities and Services Tracking (PHAST) database. We conducted our analysis in 2014-2015. Data were linked with variables depicting local context and LHD structure. We used a cross-sectional study design to identify communities with better than expected MCH outcomes and multiple regression analysis to control for factors outside of and within LHD control. RESULTS: We identified 50 positive deviant LHD jurisdictions across 3 states: WA = 10 (29 %); FL = 24 (36 %); NY = 16 (33 %). Overall, internal factor variables improved model fit for identifying PD LHD jurisdictions, but individual variables were not significant. CONCLUSIONS: We empirically identified LHD jurisdictions with better MCH outcomes compared to their peers. Research is needed to assess what factors contributed to these exceptional MCH outcomes and over which LHDs have control. The positive deviance method we used to identify high performing local health jurisdictions in the area of maternal and child health outcomes can assist in better understanding what practices work to improve health outcomes. We found that funding may not be the only predictor of exceptional outcomes, but rather, there may be activities that positive deviant LHDs are conducting that lead to improved outcomes, even during difficult financial circumstances. This method can be applied to other outcomes, communities, and/or services.

The Importance of Partnerships in Local Health Department Practice Among Communities With Exceptional Maternal and Child Health Outcomes.

OBJECTIVES: The purpose of this study was to identify unique practices underway in communities that have been empirically identified as having achieved exceptional maternal and child health (MCH) outcomes compared with their peers. METHODS: We used a qualitative, positive deviance approach to identify practices implemented by local health department (LHD) jurisdictions in Florida, Washington, and New York that achieved better MCH outcomes than expected compared with their in-state peer jurisdictions. We identified a total of 50 LHDs in jurisdictions that had better than expected MCH outcomes compared with their peers, and we conducted 39 hour-long semistructured interviews with LHD staff. We conducted inductive thematic analysis to identify key themes and subthemes across all LHD cases in the sample. RESULTS: Partnerships with providers, partnerships for data collection/assessment, and partnerships with community-based organizations were associated with exceptional MCH outcomes based on our interviews. DISCUSSION: This study offers specific examples of practices LHDs can implement to improve MCH outcomes, even with limited resources, based on the practices of high-performing local health jurisdictions.

Using incident reports to diagnose communication challenges for precision intervention in learning health systems: A methods paper.

Introduction: Poor communication is a leading root cause of preventable maternal mortality in the United States. Communication challenges are compounded with the presence of biases, including racism. Hospital administrators and clinicians are often aware that communication is a problem, but understanding where to intervene can be difficult to determine. While clinical leadership routinely reviews incident reports and acts on them to improve care, we hypothesized that reviewing incident reports in a systematic way might reveal thematic patterns, providing targeted opportunities to improve communication in direct interaction with patients and within the healthcare team itself. Methods: We abstracted incident reports from the Women's Health service and linked them with patient charts to join patient's race/ethnicity, birth outcome, and presence of maternal morbidity and mortality to the incident report. We conducted a qualitative content analysis of incident reports using an inductive and deductive approach to categorizing communication challenges. We then described the intersection of different types of communication challenges with patient race/ethnicity and morbidity outcomes. Results: The use of incident reports to conduct research on communication was new for the health system. Conversations with health system-level stakeholders were important to determine the best way to manage data. We developed a thematic codebook based on prior research in healthcare communication. We found that we needed to add codes that were equity focused, as this was missing from the existing codebook. We also found that clinical and contextual expertise was necessary for conducting the analysis-requiring more resources to conduct coding than initially estimated. We shared our findings back with leadership iteratively during the work. Conclusions: Incident reports represent a promising source of health system data for rapid improvement to transform organizational practice around communication. There are barriers to conducting this work in a rapid manner, however, that require further iteration and innovation.

Negotiating severity behind the scenes: prenatal testing in Germany.

Foetal-related severity is a key concept in policy and legislation relating to access to both reproductive technologies and selective abortions in many countries around the world, but not in Germany. This study sheds light on how 'severity' in the context of prenatal testing is understood and negotiated within the particular socio-cultural and legal context of Germany, where 'severity' relating to foetal clinical findings neither counts as a justification to implement population prenatal screening programs, nor as a legal ground to terminate pregnancy. This study explores the views of women who undergo prenatal testing, as well as of professionals who encounter them, through semi-structured interviews. It showcases how they frame severity and questions whether the existing legal and regulatory framework relating to prenatal testing and termination of pregnancy addresses their concerns and needs regarding reproductive decision-making. The interviews (n = 27) reveal that despite it being legally outside the explicit reasons for testing and termination of pregnancy, both women and professionals negotiate severity behind the scenes. Their interpretation of severity is highly context-dependent and relies on clinical, social and familial facets. Their perceptions of severity guide them in their handling of and decision-making around pregnancy management. Acknowledging the personal nature of severity assessment and providing professional or legal guidance which explicitly mentions foetal anomaly as a legitimate factor in pregnancy management could provide healthcare professionals and patients with the room needed to manage the pregnancy favourably.

Clinician Perspectives on Virtual Specialty Palliative Care for Patients With Advanced Illnesses.

Background: Patients with serious illnesses have unmet symptom and psychosocial needs. Specialty palliative care could address many of these needs; however, access varies by geography and health system. Virtual visits and automated referrals could increase access and lead to improved quality of life, health outcomes, and patient-centered care for patients with serious illness. Objectives: We sought to understand referring clinician perspectives on barriers and facilitators to utilizing virtual tools to increase upstream access to palliative care. Design: Participants in this multisite qualitative study included practicing clinicians who commonly place palliative care referrals across multiple specialties, including hematology/oncology, family medicine, cardiology, and geriatrics. All interviews were transcribed and subsequently coded and analyzed by trained research coordinators using Atlas.ti software. Settings/Subjects: This study included 23 clinicians (21 physicians, 2 nonphysicians) across 5 specialties, 4 practice settings, and 7 states in the United States. Results: Respondents felt that community-based specialty palliative services including symptom management, advance care planning, physical therapy, and mental health counseling would benefit their patients. However, they had mixed feelings about automated referrals, with some clinicians feeling hesitant about not being alerted to such referrals. Many respondents were supportive of virtual palliative care, particularly for those who may have difficulty accessing physician offices, but most respondents felt that such care should only be provided after an initial in-person consultation where clinicians can meet face-to-face with patients. Conclusion: Clinicians believe that automated referrals and virtual palliative care could increase access to the benefits of specialty palliative care. However, virtual palliative care models should give attention to iterative communication with primary clinicians and the perceived need for an initial in-person visit.

Family cascade screening for equitable identification of familial hypercholesterolemia: study protocol for a hybrid effectiveness-implementation type III randomized controlled trial.

BACKGROUND: Familial hypercholesterolemia (FH) is a heritable disorder affecting 1.3 million individuals in the USA. Eighty percent of people with FH are undiagnosed, particularly minoritized populations including Black or African American people, Asian or Asian American people, and women across racial groups. Family cascade screening is an evidence-based practice that can increase diagnosis and improve health outcomes but is rarely implemented in routine practice, representing an important care gap. In pilot work, we leveraged best practices from behavioral economics and implementation science-including mixed-methods contextual inquiry with clinicians, patients, and health system constituents-to co-design two patient-facing implementation strategies to address this care gap: (a) an automated health system-mediated strategy and (b) a nonprofit foundation-mediated strategy with contact from a foundation-employed care navigator. This trial will test the comparative effectiveness of these strategies on completion of cascade screening for relatives of individuals with FH, centering equitable reach. METHODS: We will conduct a hybrid effectiveness-implementation type III randomized controlled trial testing the comparative effectiveness of two strategies for implementing cascade screening with 220 individuals with FH (i.e., probands) per arm identified from a large northeastern health system. The primary implementation outcome is reach, or the proportion of probands with at least one first-degree biological relative (parent, sibling, child) in the USA who is screened for FH through the study. Our secondary implementation outcomes include the number of relatives screened and the number of relatives meeting the American Heart Association criteria for FH. Our secondary clinical effectiveness outcome is post-trial proband cholesterol level. We will also use mixed methods to identify implementation strategy mechanisms for implementation strategy effectiveness while centering equity. DISCUSSION: We will test two patient-facing implementation strategies harnessing insights from behavioral economics that were developed collaboratively with constituents. This trial will improve our understanding of how to implement evidence-based cascade screening for FH, which implementation strategies work, for whom, and why. Learnings from this trial can be used to equitably scale cascade screening programs for FH nationally and inform cascade screening implementation efforts for other genetic disorders. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05750667. Registered 15 February 2023-retrospectively registered, https://clinicaltrials.gov/study/NCT05750667 .

B-OK: A Visual and Tactile Tool for HIV Treatment Adherence Support in a United States Urban Center.

Lack of adherence to antiretroviral therapy (ART) and poor retention in care are significant barriers to ending HIV epidemics. Treatment adherence support (TAS) effectiveness may be constrained by limited awareness and understanding of the benefits of ART, particularly the concepts of treatment as prevention and Undetectable=Untransmittable (U=U), for which substantial knowledge gaps persist. We used mixed methods to evaluate a straightforward visual and tactile tool, the B-OK Bottles ("B-OK"), that incorporates human-centered design and behavioral economics principles and is designed to change and strengthen mental models about HIV disease progression and transmission. We enrolled 118 consenting adults living with HIV who were clients of medical case managers at one of four case management agencies in Philadelphia. All participants completed a pre-intervention survey, a B-OK intervention, and a post-intervention survey. A subset (N=52) also completed qualitative interviews before (N=20) or after (N=32) B-OK. Participants had a median age of 55 years (IQR 47-60), about two-thirds were male sex (N=77, 65%), nearly three-quarters identified as non-Hispanic Black (N=85, 72%), and almost all reported receiving ART (N=116, 98%). Exposure to B-OK was associated with improved awareness and understanding of HIV terminology, changes in attitudes about HIV treatment, and increased intention to rely on HIV treatment for transmission prevention. Insights from qualitative interviews aligned with the quantitative findings as respondents expressed a better understanding of U=U and felt that B-OK clearly explained concepts of HIV treatment and prevention. These findings provide a strong rationale to further evaluate the potential for B-OK to improve TAS for PLWH.

Hospice Administrators' and Providers' Perspectives on Providing Upstream Palliative Care: Facilitators, Barriers, and Policy Prescriptions.

Background: Among patients with serious illness, palliative care before hospice enrollment is associated with improved quality of life, reduced symptom burden, and earlier transitions to hospice. However, fewer than half of eligible patients receive specialty palliative care referrals. As most hospice clinicians and administrators have experience in specialty palliative care, several emerging programs propose engaging hospice clinicians to provide early palliative care. Objective: We sought to identify barriers and facilitators to upstream palliative care. Design: We conducted a key informant qualitative study among hospice administrators and clinicians. Setting/Subjects: We conducted semi-structured interviews with 23 hospice administrators and clinicians in eight states from March to August 2022. We identified participants using snowball and purposive sampling using states that participate in Medicare Advantage's value-based insurance design Model. Results: Respondents indicated that barriers to early palliative care included inadequate staffing and reimbursement. Hospice clinicians providing community-based palliative care can address access barriers and improve transitions to hospice. Respondents expressed desire for payer guidance in identifying eligible patients but were cautious about payers acting as direct palliative care providers. However, payers could facilitate uptake by broadening and specifying coverage of services to include goals of care conversations and symptom management. Routine referrals initiated by objective measures could potentially increase access. Conclusions: Utilizing hospice providers to provide upstream palliative care can increase access, improve outcomes, and ease the transition to hospice.

Measuring Quality-weighted Hospital-Free Days in Acute Respiratory Failure: A Modified Delphi Study.

Rationale: Hospital-free days (HFDs), a measure of the number of days alive spent outside the hospital, is increasingly used as an endpoint in studies of patients with acute respiratory failure (ARF) or other critical and serious illnesses. Current approaches to measuring HFDs do not account for decrements in functional status or quality of life that ARF survivors and family members value. Objectives: To develop an acceptable approach to measure quality-weighted HFDs using patient-reported outcomes. Methods: We conducted a four-round modified Delphi process among ARF experts: those with lived or professional experience. Experts rated survivorship domains, instrument and data collection characteristics, and methods to translate responses into quality-weighted HFDs. The consensus threshold was that ⩾70% of respondents rated an item "totally acceptable" or "acceptable" and ⩽15% of respondents rated the item "totally unacceptable," "unacceptable," or "slightly unacceptable." Results: Fifty-seven experts participated in round 1. Response rates were 82-93% for subsequent rounds. Priority survivorship domains were physical function and health-related quality of life. Participants reached a consensus that data collection during ARF recovery should take less than 15 minutes per assessment, allow surrogate completion when patients are unable, and continue for at least 24 months of follow-up. Using the EuroQol-5 Dimensions (EQ-5D) questionnaire to quality weight HFDs met consensus criteria for acceptability. A majority of panelists preferred quality-weighted HFDs to unweighted HFDs or survival for use in future ARF studies. Conclusions: Quality-weighting HFDs using patient and/or surrogate responses to the EQ-5D captured stakeholder priorities and was acceptable to this Delphi panel.

Coordinating research and practice: challenges testing messages to increase medical reserve corps participation in local health department activities.

Local health departments (LHDs) increasingly depend on volunteers, often Medical Reserve Corps (MRC) volunteers, to assist with a variety of functions. While LHDs have extensive lists of volunteers, only about 10 % are actively involved in LHD activities. Psychological literature has shown that well-designed messages can motivate behavior among individuals. Key to this theory is the concept of "framing," defined as the influence the characterization of an issue can have on its understanding. Research has been conducted on how to frame and disseminate both political and public health messages to alter individual behavior. We aimed to design and test appropriate evidence-based messages to increase volunteer participation rates in LHD flu clinics. After inviting over 900 MRC units to participate during the 2011-2012 influenza season, five were able to collect and report data to the research team. Using a randomized trial design, we tested messages among the five participating MRC units consisting of a total of 2,020 volunteers. Chi Square analysis showed no difference in attendance between those who received either of the test messages versus the control message (p = .305). Our small sample size of MRC units likely biased our sample and reduced the external validity of our study. Our experience in conducting research with MRC coordinators and volunteers highlights the challenges of conducting research with practitioners who lack the time, infrastructure and resources necessary to work with researchers. There is a strong need for more supportive infrastructure for conducting research with practitioners.

Local health department public vaccination clinic success during 2009 pH1N1.

CONTEXT: Local health departments (LHDs) were responsible for administering vaccine to the public during the 2009 H1N1 campaign but had relatively little guidance or experience to inform such a large campaign with limited vaccine supply. They used various processes to deliver vaccines to the public. Learning from the LHDs that were successful in their public vaccination campaigns can help inform future vaccination efforts. OBJECTIVE: To learn from H1N1 campaign in order to improve responses to similar events in the future. We used a positive deviance approach to identify positive outlier LHDs during the 2009 H1N1 vaccination campaigns. We then used realist evaluation to learn about the combinations of context and mechanisms that led select LHDs to perform well. DESIGN: This project was a retrospective qualitative study. We used process mapping to define the steps involved in implementing public vaccination clinics. We identified positive outliers in H1N1 public vaccination efforts and conducted in-depth interviews with LHD staff to learn about the context and mechanisms that led to successful public vaccination clinics. PARTICIPANTS: This study focused on positive outliers in LHD vaccination efforts during the 2009 H1N1 campaign that implemented public vaccination clinics. MAIN OUTCOME MEASURE(S): Study outcomes focused on the combinations of context and mechanisms that led to successful outcomes in high-performing LHDs. Specific context + mechanism = outcomes stories are reported. RESULTS: We found that successful LHDs defined priority groups, communicated with the public, maintained adequate staffing, established community partnerships, and maintained flexibility. We describe the specific contexts that triggered key mechanisms, which, when combined, led to successful outcomes. CONCLUSIONS: The positive deviance and realist evaluation approach allowed us to understand how LHD context triggered specific mechanisms, which led to successful public clinics. The experience of successful LHDs can assist similar LHDs in implementing successful public vaccination clinics in the future.

Patient- and Team-Level Characteristics Associated with Handoff Protocol Fidelity in a Hybrid Implementation Study: Results from a Qualitative Comparative Analysis.

BACKGROUND: Standardization is an evidence-based approach to improve handoffs. The factors underpinning fidelity (that is, adherence) to standardized handoff protocols are not well specified, which hampers implementation and sustainability efforts. METHODS: The Handoffs and Transitions in Critical Care (HATRICC) study (2014-2017) involved the creation and implementation of a standardized protocol for operating room (OR)-to-ICU handoffs in two mixed surgical ICUs. The present study used fuzzy-set qualitative comparative analysis (fsQCA) to characterize combinations of conditions associated with fidelity to the HATRICC protocol. Conditions were derived from postintervention handoff observations yielding quantitative and qualitative data. RESULTS: Sixty handoffs had complete fidelity data. Four conditions from the SEIPS 2.0 model were used to explain fidelity: (1) whether the patient was newly admitted to the ICU; (2) presence of an ICU provider; (3) observer ratings of attention-paying by the handoff team; and (4) whether the handoff took place in a quiet environment. None of the conditions were singly necessary or sufficient for high fidelity. Three combinations of conditions were sufficient for fidelity: (1) presence of the ICU provider and high attention ratings; (2) a newly admitted patient, presence of the ICU provider, and quiet environment; and (3) a newly admitted patient, high attention ratings, and quiet environment. These three combinations explained 93.5% of the cases demonstrating high fidelity. CONCLUSION: In a study of OR-to-ICU handoff standardization, multiple combinations of contextual factors were associated with handoff protocol fidelity. Handoff implementation efforts should consider multiple fidelity-promoting strategies that support these combinations of conditions.

Qualitative Analysis of a Remote Monitoring Intervention for Managing Heart Failure.

Background : Heart failure (HF) is one of the most common reasons for hospital admission and is a major cause of morbidity, mortality, and increasing health care costs. The EMPOWER study was a randomized trial that used remote monitoring technology to track patients' weight and diuretic adherence and a state-of-the-art approach derived from behavioral economics to motivate adherence to the reverse monitoring technology. Objective : The goal was to explore patient and clinician perceptions of the program and its impact on health outcomes and better understand why some patients/clinicians did better/worse than others in response to the intervention. Approach : This was a retrospective qualitative study to understand the trial's processes, reflecting on successes and areas for improvement for future iterations of behavioral economic interventions. Key Results: Many patients felt supported, and they appreciated the intervention. Many also appreciated the lottery intervention, and while it was not an incentive for enrolling for many respondents, it may have increased adherence during the study. Clinicians felt that the intervention integrated well into their workflow, but the number of alerts was burdensome. Additionally, responses to alerts varied considerably by provider, perhaps because there are no professional guidelines for alerts unaccompanied by severe symptoms. Conclusion : Those interviews offer insights into the potential reasons for the study's null result and opportunities for improvements in the future. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.