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Item Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure).(American Heart Association, 2017-02) Fermann, Gregory J.; Levy, Phillip D.; Pang, Peter; Butler, Javed; Ayaz, S. Imran; Char, Douglas; Dunn, Pat; Jenkins, Cathy A.; Kampe, Christy; Khan, Yosef; Kumar, Vijaya A.; Lindenfeld, JoAnn; Liu, Dandan; Miller, Karen; Peacock, W. Frank; Rizk, Samaa; Robichaux, Chad; Rothman, Russell L.; Schrock, Jon; Singer, Adam; Sterling, Sarah A.; Storrow, Alan B.; Walsh, Cheryl; Wilburn, John; Collins, Sean P.; Emergency Medicine, School of MedicineGUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure) is a multicenter randomized trial of a patient-centered transitional care intervention in patients with acute heart failure (AHF) who are discharged either directly from the emergency department (ED) or after a brief period of ED-based observation. To optimize care and reduce ED and hospital revisits, there has been significant emphasis on improving transitions at the time of hospital discharge for patients with HF. Such efforts have been almost exclusively directed at hospitalized patients; individuals with AHF who are discharged from the ED or ED-based observation are not included in these transitional care initiatives. Patients with AHF discharged directly from the ED or after a brief period of ED-based observation are randomly assigned to our transition GUIDED-HF strategy or standard ED discharge. Patients in the GUIDED arm receive a tailored discharge plan via the study team, based on their identified barriers to outpatient management and associated guideline-based interventions. This plan includes conducting a home visit soon after ED discharge combined with close outpatient follow-up and subsequent coaching calls to improve postdischarge care and avoid subsequent ED revisits and inpatient admissions. Up to 700 patients at 11 sites will be enrolled over 3 years of the study. GUIDED-HF will test a novel approach to AHF management strategy that includes tailored transitional care for patients discharged from the ED or ED-based observation. If successful, this program may significantly alter the current paradigm of AHF patient care.Item Diagnosis and Management of Type 2 Diabetic Kidney Disease(American Society of Nephrology, 2017-08-07) Doshi, Simit M.; Friedman, Allon N.; Medicine, School of MedicineType 2 diabetic kidney disease (DKD) is the most common cause of CKD and ESRD worldwide, and carries with it enormous human and societal costs. The goal of this review is to provide an update on the diagnosis and management of DKD based on a comprehensive review of the medical literature. Topics addressed include the evolving presentation of DKD, clinical differentiation of DKD from non-DKD, a state-of-the-art evaluation of current treatment strategies, and promising emerging treatments. It is expected that the review will help clinicians to diagnose and manage patients with DKD.Item Evaluating the feasibility of implementing a Telesleep pilot program using two-tiered external facilitation(BMC, 2020) Rattray, Nicholas A.; Khaw, Andrew; McGrath, Mackenzie; Damush, Teresa M.; Miech, Edward J.; Lenet, Adam; Stahl, Stephanie M.; Ferguson, Jared; Myers, Jennifer; Guenther, David; Homoya, Barbara J.; Bravata, Dawn M.; Anthropology, School of Liberal ArtsBackground: Obstructive sleep apnea (OSA) can negatively impact patients' health status and outcomes. Positive airway pressure (PAP) reverses airway obstruction and may reduce the risk of adverse outcomes. Remote monitoring of PAP (as opposed to in-person visits) may improve access to sleep medicine services. This study aimed to evaluate the feasibility of implementing a clinical program that delivers treatment for OSA through PAP remote monitoring using external facilitation as an implementation strategy. Methods: Participants included patients with OSA at a Veteran Affairs Medical Center (VAMC). PAP adherence and clinical disease severity on treatment (measured by the apnea hypopnea index [AHI]) were the preliminary effectiveness outcomes across two delivery models: usual care (in-person) and Telehealth nurse-delivered remote monitoring. We also assessed visit duration and travel distance. A prospective, mixed-methods evaluation examined the two-tiered external facilitation implementation strategy. Results: The pilot project included N = 52 usual care patients and N = 38 Telehealth nurse-delivered remote monitoring patients. PAP adherence and disease severity were similar across the delivery modalities. However, remote monitoring visits were 50% shorter than in-person visits and saved a mean of 72 miles of travel (median = 45.6, SD = 59.0, mode = 17.8, range 5.4-220). A total of 62 interviews were conducted during implementation with a purposive sample of 12 clinical staff involved in program implementation. Weekly external facilitation delivered to both front-line staff and supervisory physicians was necessary to ensure patient enrollment and treatment. Synchronized, "two-tiered" facilitation at the executive and coordinator levels proved crucial to developing the clinical and administrative infrastructure to support a PAP remote monitoring program and to overcome implementation barriers. Conclusions: Remote PAP monitoring had similar efficacy to in-person PAP services in this Veteran population. Although external facilitation is a widely-recognized implementation strategy in quality improvement projects, less is known about how multiple facilitators work together to help implement complex programs. Two-tiered facilitation offers a model well-suited to programs where innovations span disciplines, disrupt professional hierarchies (such as those between service chiefs, clinicians, and technicians) and bring together providers who do not know each other, yet must collaborate to improve access to care.Item Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Performance Status Work Group(American Association for Cancer Research, 2021-05-01) Magnuson, Allison; Bruinooge, Suanna S.; Singh, Harpreet; Wilner, Keith D.; Jalal, Shadia; Lichtman, Stuart M.; Kluetz, Paul G.; Lyman, Gary H.; Klepin, Heidi D.; Fleury, Mark E.; Hirsch, Brad; Melemed, Allen; Arnaldez, Fernanda I.; Roy, Upal Basu; Schenkel, Caroline; Sherwood, Shimere; Garrett-Mayer, Elizabeth; Medicine, School of MedicinePurpose: Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias. Experimental design: A multidisciplinary working group of the American Society of Clinical Oncology and Friends of Cancer Research evaluated how PS eligibility criteria could be more inclusive. The working group recommendations are based on a literature search, review of trials, simulation study, and multistakeholder consensus. The working group prioritized inclusiveness and access to investigational therapies, while balancing patient safety and study integrity. Results: Broadening PS eligibility criteria may increase the number of potentially eligible patients for a given clinical trial, thus shortening accrual time. It may also result in greater participant diversity, potentially reduce trial participant and patient disparities, and enable clinicians to more readily translate trial results to patients with low-functioning PS. Potential impact on outcomes was explored through a simulation trial demonstrating that when the number of Eastern Cooperative Oncology Group PS2 participants was relatively small, the effect on the estimated HR and power was modest, even when PS2 patients did not derive a treatment benefit. Conclusions: Expanding PS eligibility criteria to be more inclusive may be justified in many cases and could result in faster accrual rates and more representative trial populations.Item Parents’ Communication Work in the Management of Food Allergies(Taylor & Francis, 2021-02-02) Bute, Jennifer J.; Bowers, Clarissa; Park, Daniel; Communication Studies, School of Liberal ArtsThe National Academies of Sciences, Engineering, and Medicine (NASEM) has identified food allergies as a critical public health issue that significantly affects quality of life for patients and their families. Despite the crisis-level status of food allergies, especially in children, there are currently no curative treatments. As a result, impacted families must learn how to carry the burden of disease management. Using an expanded application of the concept of communication work, this study features data from interviews with 26 parents of food allergic children and explores how parents navigate the nuances of food allergy maintenance while negotiating and preserving valued relationships and identities through everyday talk. Results revealed that parents used communication to legitimate food allergy, balance potential face-threats with identity and relational goals, and coordinate care with spouses. Due to the lack of therapeutic treatment options, we found that parents utilize communication work, which is both demanding and effortful, as a form of disease management.Item Predicting pharmacotherapeutic outcomes for type 2 diabetes: An evaluation of three approaches to leveraging electronic health record data from multiple sources(Elsevier, 2022-05) Tarumi, Shinji; Takeuchi, Wataru; Qi, Rong; Ning, Xia; Ruppert, Laura; Ban, Hideyuki; Robertson, Daniel H.; Schleyer, Titus; Kawamoto, Kensaku; Medicine, School of MedicineElectronic health record (EHR) data are increasingly used to develop prediction models to support clinical care, including the care of patients with common chronic conditions. A key challenge for individual healthcare systems in developing such models is that they may not be able to achieve the desired degree of robustness using only their own data. A potential solution—combining data from multiple sources—faces barriers such as the need for data normalization and concerns about sharing patient information across institutions. To address these challenges, we evaluated three alternative approaches to using EHR data from multiple healthcare systems in predicting the outcome of pharmacotherapy for type 2 diabetes mellitus (T2DM). Two of the three approaches, named Selecting Better (SB) and Weighted Average (WA), allowed the data to remain within institutional boundaries by using pre-built prediction models; the third, named Combining Data (CD), aggregated raw patient data into a single dataset. The prediction performance and prediction coverage of the resulting models were compared to single-institution models to help judge the relative value of adding external data and to determine the best method to generate optimal models for clinical decision support. The results showed that models using WA and CD achieved higher prediction performance than single-institution models for common treatment patterns. CD outperformed the other two approaches in prediction coverage, which we defined as the number of treatment patterns predicted with an Area Under Curve of 0.70 or more. We concluded that 1) WA is an effective option for improving prediction performance for common treatment patterns when data cannot be shared across institutional boundaries and 2) CD is the most effective approach when such sharing is possible, especially for increasing the range of treatment patterns that can be predicted to support clinical decision making.Item Readmission in acute pancreatitis: Etiology, risk factors, and opportunities for improvement(Elsevier, 2022-10) Bogan, Brittany D.; McGuire, Sean P.; Maatman, Thomas K.; Surgery, School of MedicineAcute pancreatitis is associated with a readmission rate ranging from 7 to 34%. Readmission rates are highest among biliary (4–37%) and alcohol-induced (2–60%) acute pancreatitis. Severe acute pancreatitis and necrotizing pancreatitis have readmission rates ranging from 20 to 75%. The most common causes of readmission include recurrent acute pancreatitis (17–45% of readmissions) and smoldering symptoms/local complications (17–38%). A number of risk scores reliably estimate risk of readmission in acute pancreatitis. Decreased rates of readmission were reported in patients that underwent same-admission cholecystectomy in biliary pancreatitis and alcohol cessation interventions in alcohol-induced pancreatitis. This review article discusses readmission in acute pancreatitis, including etiology, risk factors, and opportunities for improved patient care.Item Treatment patterns and outcomes in elderly patients with newly diagnosed multiple myeloma: results from the Connect® MM Registry(Springer Nature, 2021-07-23) Lee, Hans C.; Ailawadhi, Sikander; Gasparetto, Cristina J.; Jagannath, Sundar; Rifkin, Robert M.; Durie, Brian G. M.; Narang, Mohit; Terebelo, Howard R.; Toomey, Kathleen; Hardin, James W.; Wagner, Lynne; Omel, James L.; Dhalla, Mazaher; Liu, Liang; Joshi, Prashant; Abonour, Rafat; Connect® MM Registry; Medicine, School of MedicineItem What is in a name: defining pediatric refractory ITP(American Society of Hematology, 2024) Nakano, Taizo A.; Grimes, Amanda B.; Klaassen, Robert J.; Lambert, Michele P.; Neunert, Cindy; Rothman, Jennifer A.; Shimano, Kristin A.; Amend, Christina; Askew, Megan; Badawy, Sherif M.; Baker, Jillian M.; Breakey, Vicky; Crary, Shelley; Davini, Monica; Fritch Lilla, Stephanie; Gilbert, Megan; Hays, Taru; Hege, Kerry; Hillier, Kirsty; Jacobson-Kelly, Amanda; Kaicker, Shipra; Kim, Taylor O.; Kochhar, Manpreet; Leblanc, Thierry; Martinelli, Marie; Nunez, Mara; Remiker, Allison; Schultz, Corrina; Sharma, Ruchika; Grace, Rachael F.; Pediatrics, School of MedicineThere are no agreed upon terminology to define "refractory" pediatric immune thrombocytopenia (ITP). Guidelines are therefore limited to arbitrary and outdated definitions. The Pediatric ITP Consortium of North America held a meeting in 2023 to define this entity. With 100% agreement, the faculty established that pediatric ITP that is refractory to emergent therapy could be defined as no platelet response after treatment with all eligible emergent pharmacotherapies. With 100% agreement, the working group established that pediatric patients with ITP that continue to demonstrate high disease burden and/or no platelet response despite treatment with multiple classes of disease-modifying therapies represent a challenging subset of ITP. These patients are at higher risk of ongoing disease burden and merit additional investigation as well as consideration for clinical trials or novel therapies. Future efforts to define disease burden and disease response will be completed in collaboration with the ITP International Working Group.