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.

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.

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.

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 4-round modified Delphi 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 consensus that data collection during ARF recovery should take fewer than 15 minutes per assessment, allow for surrogate completion when patients are unable, and continue for at least 24 months of follow-up. Using the EuroQol-5 Dimensions (EQ-5D) 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.

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.

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- 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.

Clinician Perceptions of Receiving Different Forms of Feedback on their Opioid Prescribing.

Opioid misuse represents a major public health issue in the United States. One driver is overprescription for acute pain, with the size of initial prescription associated with subsequent long-term use. However, little work has been done to elicit clinician feedback about interventions to reduce opioid prescribing. To address this knowledge gap, qualitative analyses were conducted with clinicians who participated in a randomized controlled trial in which clinicians received monthly emailed feedback notifications about their opioid prescribing behaviors. Semistructured telephone interviews were conducted (N = 12) with urgent care (N = 7) and emergency department (N = 5) clinicians who participated in the trial between November 2020 and April 2021. Clinicians appreciated feedback about their prescribing behavior and found comparative data with peer clinicians to be most useful. Sharing opioid prescribing feedback data with clinicians can be an acceptable way to address opioid prescribing among emergency and urgent care clinicians.

Well-Being Among Respiratory Therapists in an Academic Medical Center During the COVID-19 Pandemic.

BACKGROUND: Recent studies have revealed high rates of burnout among respiratory therapists (RTs), which has implications for patient care and outcomes as well as for the health care workforce. We sought to better understand RT well-being during the COVID-19 pandemic. The purpose of this study was to determine rates and identify determinants of well-being, including burnout and professional fulfillment, among RTs in ICUs. METHODS: We conducted a mixed-methods study comprised of a survey administered quarterly from July 2020-May 2021 to critical-care health care professionals and semi-structured interviews from April-May 2021 with 10 ICU RTs within a single health center. We performed multivariable analyses to compare RT well-being to other professional groups and to evaluate changes in well-being over time. We analyzed qualitative interview data using thematic analysis, followed by mapping themes to the Maslow needs hierarchy. RESULTS: One hundred eight RTs responded to at least one quarterly survey. Eighty-two (75%) experienced burnout; 39 (36%) experienced professional fulfillment, and 62 (58%) reported symptoms of depression. Compared to clinicians of other professions in multivariable analyses, RTs were significantly more likely to experience burnout (odds ratio 2.32 [95% CI 1.41-3.81]) and depression (odds ratio 2.73 [95% CI 1.65-4.51]) and less likely to experience fulfillment (odds ratio 0.51 [95% CI 0.31-0.85]). We found that staffing challenges, safety concerns, workplace conflict, and lack of work-life balance led to burnout. Patient care, use of specialized skills, appreciation and a sense of community at work, and purpose fostered professional fulfillment. Themes identified were mapped to Maslow's hierarchy of needs; met needs led to professional fulfillment, and unmet needs led to burnout. CONCLUSIONS: ICU RTs experienced burnout during the pandemic at rates higher than other professions. To address RT needs, institutions should design and implement strategies to reduce burnout across all levels.

Remote Monitoring and Behavioral Economics in Managing Heart Failure in Patients Discharged From the Hospital: A Randomized Clinical Trial.

Importance: Close remote monitoring of patients following discharge for heart failure (HF) may reduce readmissions or death. Objective: To determine whether remote monitoring of diuretic adherence and weight changes with financial incentives reduces hospital readmissions or death following discharge with HF. Design, Setting, and Participants: The Electronic Monitoring of Patients Offers Ways to Enhance Recovery (EMPOWER) study, a 3-hospital pragmatic trial, randomized 552 adults recently discharged with HF to usual care (n = 280) or a compound intervention (n = 272) designed to inform clinicians of diuretic adherence and changes in patient weight. Patients were recruited from May 25, 2016, to April 8, 2019, and followed up for 12 months. Investigators were blinded to assignment but patients were not. Analysis was by intent to treat. Interventions: Participants randomized to the intervention arm received digital scales, electronic pill bottles for diuretic medication, and regret lottery incentives conditional on the previous day's adherence to both medication and weight measurement, with $1.40 expected daily value. Participants' physicians were alerted if participants' weights increased 1.4 kg in 24 hours or 2.3 kg in 72 hours or if diuretic medications were missed for 5 days. Alerts and weights were integrated into the electronic health record. Participants randomized to the control arm received usual care and no further study contact. Main Outcomes and Measures: Time to death or readmission for any cause within 12 months. Results: Of the 552 participants, 290 were men (52.5%); 291 patients (52.7%) were Black, 231 were White (41.8%), and 16 were Hispanic (2.9%); mean (SD) age was 64.5 (11.8) years. The mean (SD) ejection fraction was 43% (18.1%). Each month, approximately 75% of participants were 80% adherent to both medication and weight measurement. There were 423 readmissions and 26 deaths in the control group and 377 readmissions and 23 deaths in the intervention group. There was no significant difference between the 2 groups for the combined outcome of all-cause inpatient readmission or death (unadjusted hazard ratio, 0.91; 95% CI, 0.74-1.13; P = .40) and no significant differences in all-cause inpatient readmission or observation stay or death, all-cause cardiovascular readmission or death, time to first event, and total all-cause deaths. Participants in the intervention group were slightly more likely to spend fewer days in the hospital. Conclusions and Relevance: In this randomized clinical trial, there was no reduction in the combined outcome of readmission or mortality in a year-long intensive remote monitoring program with incentives for patients previously hospitalized for HF. Trial Registration: ClinicalTrials.gov Identifier: NCT02708654.

Views on disability and prenatal testing among families with Down syndrome and disability activists: A comparative analysis of interviews from Germany and Israel.

The prenatal genetic testing arena has witnessed great changes over the past decades and has been the focus of extensive discussion of its ethical, legal, and social implications. Germany and Israel were previously known for strongly contrasting regulations and attitudes of both professionals and laypeople towards genetic testing. Based on qualitative analysis of 37 semi-structured interviews, this study compares German and Israeli family members of individuals with Down syndrome and disability activists, thereby examining the interplay between lived experience and cultural scripts and their impact on the formation of personal views toward disability and prenatal testing. We have found that the differences between Germany and Israel remain, despite the emergence of new technologies, and that family members and disability activists reflect the norms of their socio-cultural environments, thereby emphasising the role society plays in shaping the views of those with direct experience of disability.

Impact of Behavioral Nudges on the Quality of Serious Illness Conversations Among Patients With Cancer: Secondary Analysis of a Randomized Controlled Trial.

PURPOSE: Serious Illness Conversations (SICs) are structured conversations between clinicians and patients about prognosis, treatment goals, and end-of-life preferences. Although behavioral interventions may prompt earlier or more frequent SICs, their impact on the quality of SICs is unclear. METHODS: This was a secondary analysis of a randomized clinical trial (NCT03984773) among 78 clinicians and 14,607 patients with cancer testing the impact of an automated mortality prediction with behavioral nudges to clinicians to prompt more SICs. We analyzed 318 randomly selected SICs matched 1:1 by clinicians (159 control and 159 intervention) to compare the quality of intervention vs. control conversations using a validated codebook. Comprehensiveness of SIC documentation was used as a measure of quality, with higher integer numbers of documented conversation domains corresponding to higher quality conversations. A conversation was classified as high-quality if its score was ≥ 8 of a maximum of 10. Using a noninferiority design, mixed effects regression models with clinician-level random effects were used to assess SIC quality in intervention vs. control groups, concluding noninferiority if the adjusted odds ratio (aOR) was not significantly < 0.9. RESULTS: Baseline characteristics of the control and intervention groups were similar. Intervention SICs were noninferior to control conversations (aOR 0.99; 95% CI, 0.91 to 1.09). The intervention increased the likelihood of addressing patient-clinician relationship (aOR = 1.99; 95% CI, 1.23 to 3.27; P < .01) and decreased the likelihood of addressing family involvement (aOR = 0.56; 95% CI, 0.34 to 0.90; P < .05). CONCLUSION: A behavioral intervention that increased SIC frequency did not decrease their quality. Behavioral prompts may increase SIC frequency without sacrificing quality.

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.

Implementing nudges to promote utilization of low tidal volume ventilation (INPUT): a stepped-wedge, hybrid type III trial of strategies to improve evidence-based mechanical ventilation management.

BACKGROUND: Behavioral economic insights have yielded strategies to overcome implementation barriers. For example, default strategies and accountable justification strategies have improved adherence to best practices in clinical settings. Embedding such strategies in the electronic health record (EHR) holds promise for simple and scalable approaches to facilitating implementation. A proven-effective but under-utilized treatment for patients who undergo mechanical ventilation involves prescribing low tidal volumes, which protects the lungs from injury. We will evaluate EHR-based implementation strategies grounded in behavioral economic theory to improve evidence-based management of mechanical ventilation. METHODS: The Implementing Nudges to Promote Utilization of low Tidal volume ventilation (INPUT) study is a pragmatic, stepped-wedge, hybrid type III effectiveness implementation trial of three strategies to improve adherence to low tidal volume ventilation. The strategies target clinicians who enter electronic orders and respiratory therapists who manage the mechanical ventilator, two key stakeholder groups. INPUT has five study arms: usual care, a default strategy within the mechanical ventilation order, an accountable justification strategy within the mechanical ventilation order, and each of the order strategies combined with an accountable justification strategy within flowsheet documentation. We will create six matched pairs of twelve intensive care units (ICUs) in five hospitals in one large health system to balance patient volume and baseline adherence to low tidal volume ventilation. We will randomly assign ICUs within each matched pair to one of the order panels, and each pair to one of six wedges, which will determine date of adoption of the order panel strategy. All ICUs will adopt the flowsheet documentation strategy 6 months afterwards. The primary outcome will be fidelity to low tidal volume ventilation. The secondary effectiveness outcomes will include in-hospital mortality, duration of mechanical ventilation, ICU and hospital length of stay, and occurrence of potential adverse events. DISCUSSION: This stepped-wedge, hybrid type III trial will provide evidence regarding the role of EHR-based behavioral economic strategies to improve adherence to evidence-based practices among patients who undergo mechanical ventilation in ICUs, thereby advancing the field of implementation science, as well as testing the effectiveness of low tidal volume ventilation among broad patient populations. TRIAL REGISTRATION: ClinicalTrials.gov , NCT04663802 . Registered 11 December 2020.

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.

Integrating Conservative kidney management Options and advance care Planning Education (COPE) into routine CKD care: a protocol for a pilot randomised controlled trial.

INTRODUCTION: Predialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education-COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status. METHODS AND ANALYSIS: This is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score <70), advanced CKD (estimated glomerular filtration rate<20 mL/min/1.73 m2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention's effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks. ETHICS AND DISSEMINATION: This protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: This trial is registered at ClinicalTrials.gov under NCT03229811.