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1. Organization of Outpatient Care After COVID-19 Hospitalization

Author

Thomas S. Valley, Amanda Schutz, Ithan D. Peltan, Kelly C. Vranas, Kusum S. Mathews, Sarah E. Jolley, Jessica A. Palakshappa, Catherine L. Hough, Jay S. Steingrub, Mark A. Tidswell, Lori-Ann Kozikowski, Cynthia Kardos, Lesley DeSouza, Rebecca M. Baron, Mayra Pinilla-Vera, David M. Rubins, Antonio Arciniegas, Richard Riker, Christine Lord, Marie-Carmelle Elie, Daniel Talmor, Nathan Shapiro, Valerie Banner-Goodspeed, Kathryn A. Hibbert, Kelsey Brait, Natalie Pulido, Alan Jones, James Galbraith, Utsav Nandi, Rebekah Peacock, Jenna Davis, Matthew Prekker, Michael Puskarich, Seth Jones, Anne Roerhl, Audrey Hendrickson, Michael Matthay, Kirsten Kangelaris, Kathleen Liu, Kimberly Yee, Hanjing Zhuo, Gregory Hendey, Steven Chang, Nida Qadir, Andrea Tam, Rebecca Beutler, Trisha Agarwal, Joseph Levitt, Jennifer G. Wilson, Angela Rogers, Jonasel Roque, Rosemary Vojnik, Timothy E. Albertson, James A. Chenoweth, Jason Y. Adams, Brian M. Morrissey, Skyler J. Pearson, Eyad Almasri, Alyssa Hughes, Marc Moss, Adit Ginde, Jeffrey McKeehan, Lani Finck, Michelle Howell, Carrie Higgins, Jason Haukoos, Stephanie Gravitz, Carolynn Lyle, Ivor S. Douglas, Terra Hiller, Audrey Goold, James Finigan, Robert Hyzy, Pauline Park, Michael Sjoding, Stephen Kay, Kristine Nelson, Kelli McDonough, Namita Jayaprakash, Emanuel P. Rivers, Jennifer Swiderek, Jasreen Kaur Gill, Jacqueline Day, Robert Sherwin, James Wooden, Thomas Mazzoco, Michelle Ng Gong, Michael Aboodi, Ayesha Asghar, Omowunmi Amosu, Hiwet Tzehaie, Aluko A. Hope, Jen-Ting Chen, Rahul Nair, Brenda Lopez, Obiageli Offor, Jarrod M. Mosier, Cameron D. Hypes, Elizabeth Salvagio, Christian Bime, Elaine Cristan, Lynne D. Richardson, Neha Goel, Patrick Maher, Samuel Acquah, Donald Cardone, Gary Oldenburg, Andrew Dunn, Duncan Hite, Kristin Hudock, Jose Gomez Arroyo, Tammy Roads, Abhijit Duggal, Eduardo Mireles-Cabodevila, Bryce R.H. Robinson, Nicholas J. Johnson, Stephanie Gundel, Laura Evans, D. Shane O'Mahony, Julie A. Wallick, Isabel Pedraza, Akram Khan, Olivia Krol, Milad Karami Jouzestani, Kelly Vranas, Donald M. Yealy, Derek C. Angus, Alexandra Weissman, David T. Huang, Aimee Boeltz-Skrtich, Steven Moore, Derek Isenberg, D. Clark Files, Chadwick Miller, Kevin Gibbs, Lori Flores, Mary LaRose, Lauren Koehler, Leigha Landreth, Peter Morris, Evan Cassity, Jamie Sturgill, Kirby Mayer, Ashley Montgomery-Yates, Marjolein de Wit, Jessica Mason, Andrew Goodwin, Abigail Grady, Patterson Burch, Kyle B. Enfield, Jeffrey M. Sturek, Mary Marshall, Joseph R. Bledsoe, Samuel M. Brown, Colin K. Grissom, Brent Armbruster, Estelle Harris, John Eppensteiner, Bria Johnston Hall, Grace L. Hall, Lauren McGowan, Andrew Bouffler, Erica Walker, Samuel Francis, Tedra Porter, Bennett P. deBoisblanc, Matthew R. Lammi, David R. Janz, Paula Lauto, Connie Romaine, Marie Sandi, Todd W. Rice, Wesley H. Self, Nancy Ringwood, Alexander Nagrebetsky, Laura Fitzgerald, Roy G. Brower, Lora A. Reineck, Neil R. Aggarwal, and Karen Bienstock

Subjects
Hospitalization, Pulmonary and Respiratory Medicine, Ambulatory Care, COVID-19, Humans, Cardiology and Cardiovascular Medicine, Critical Care and Intensive Care Medicine
Published
2022
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2. Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial

Author

Wesley H, Self, Matthew W, Semler, Lindsay M, Leither, Jonathan D, Casey, Derek C, Angus, Roy G, Brower, Steven Y, Chang, Sean P, Collins, John C, Eppensteiner, Michael R, Filbin, D Clark, Files, Kevin W, Gibbs, Adit A, Ginde, Michelle N, Gong, Frank E, Harrell, Douglas L, Hayden, Catherine L, Hough, Nicholas J, Johnson, Akram, Khan, Christopher J, Lindsell, Michael A, Matthay, Marc, Moss, Pauline K, Park, Todd W, Rice, Bryce R H, Robinson, David A, Schoenfeld, Nathan I, Shapiro, Jay S, Steingrub, Christine A, Ulysse, Alexandra, Weissman, Donald M, Yealy, B Taylor, Thompson, Samuel M, Brown, Jay, Steingrub, Howard, Smithline, Bogdan, Tiru, Mark, Tidswell, Lori, Kozikowski, Sherell, Thornton-Thompson, Leslie, De Souza, Peter, Hou, Rebecca, Baron, Anthony, Massaro, Imoigele, Aisiku, Lauren, Fredenburgh, Raghu, Seethala, Lily, Johnsky, Richard, Riker, David, Seder, Teresa, May, Michael, Baumann, Ashley, Eldridge, Christine, Lord, Nathan, Shapiro, Daniel, Talmor, Thomas, O’Mara, Charlotte, Kirk, Kelly, Harrison, Lisa, Kurt, Margaret, Schermerhorn, Valerie, Banner-Goodspeed, Katherine, Boyle, Nicole, Dubosh, Michael, Filbin, Kathryn, Hibbert, Blair, Parry, Kendall, Lavin-Parsons, Natalie, Pulido, Brendan, Lilley, Carl, Lodenstein, Justin, Margolin, Kelsey, Brait, Alan, Jones, James, Galbraith, Rebekah, Peacock, Utsav, Nandi, Taylor, Wachs, Michael, Matthay, Kathleen, Liu, Kirsten, Kangelaris, Ralph, Wang, Carolyn, Calfee, Kimberly, Yee, Gregory, Hendey, Steven, Chang, George, Lim, Nida, Qadir, Andrea, Tam, Rebecca, Beutler, Joseph, Levitt, Jenny, Wilson, Angela, Rogers, Rosemary, Vojnik, Jonasel, Roque, Timothy, Albertson, James, Chenoweth, Jason, Adams, Skyler, Pearson, Maya, Juarez, Eyad, Almasri, Mohamed, Fayed, Alyssa, Hughes, Shelly, Hillard, Ryan, Huebinger, Henry, Wang, Elizabeth, Vidales, Bela, Patel, Adit, Ginde, Amiran, Baduashvili, Jeffrey, McKeehan, Lani, Finck, Carrie, Higgins, Michelle, Howell, Ivor, Douglas, Jason, Haukoos, Terra, Hiller, Carolynn, Lyle, Alicia, Cupelo, Emily, Caruso, Claudia, Camacho, Stephanie, Gravitz, James, Finigan, Christine, Griesmer, Pauline, Park, Robert, Hyzy, Kristine, Nelson, Kelli, McDonough, Norman, Olbrich, Mark, Williams, Raj, Kapoor, Jean, Nash, Meghan, Willig, Henry, Ford, Jayna, Gardner-Gray, Mayur, Ramesh, Montefiore, Moses, Michelle, Ng Gong, Michael, Aboodi, Ayesha, Asghar, Omowunmi, Amosu, Madeline, Torres, Savneet, Kaur, Jen-Ting, Chen, Aluko, Hope, Brenda, Lopez, Kathleen, Rosales, Jee, Young You, Jarrod, Mosier, Cameron, Hypes, Bhupinder, Natt, Bryan, Borg, Elizabeth, Salvagio Campbell, R Duncan, Hite, Kristin, Hudock, Autumn, Cresie, Faysal, Alhasan, Jose, Gomez-Arroyo, Abhijit, Duggal, Omar, Mehkri, Andrei, Hastings, Debasis, Sahoo, Francois, Abi Fadel, Susan, Gole, Valerie, Shaner, Allison, Wimer, Yvonne, Meli, Alexander, King, Thomas, Terndrup, Matthew, Exline, Sonal, Pannu, Emily, Robart, Sarah, Karow, Catherine, Hough, Bryce, Robinson, Nicholas, Johnson, Daniel, Henning, Monica, Campo, Stephanie, Gundel, Sakshi, Seghal, Sarah, Katsandres, Sarah, Dean, Olivia, Krol, Milad, Jouzestani, Peter, Huynh, Donald, Yealy, Denise, Scholl, Peter, Adams, Bryan, McVerry, David, Huang, Derek, Angus, Jordan, Schooler, Steven, Moore, Clark, Files, Chadwick, Miller, Kevin, Gibbs, Mary, LaRose, Lori, Flores, Lauren, Koehler, Caryn, Morse, John, Sanders, Caitlyn, Langford, Kristen, Nanney, Masiku, MdalaGausi, Phyllis, Yeboah, Peter, Morris, Jamie, Sturgill, Sherif, Seif, Evan, Cassity, Sanjay, Dhar, Marjolein, de Wit, Jessica, Mason, Andrew, Goodwin, Greg, Hall, Abbey, Grady, Amy, Chamberlain, Samuel, Brown, Joseph, Bledsoe, Lindsay, Leither, Ithan, Peltan, Nathan, Starr, Melissa, Fergus, Valerie, Aston, Quinn, Montgomery, Rilee, Smith, Mardee, Merrill, Katie, Brown, Brent, Armbruster, Estelle, Harris, Elizabeth, Middleton, Robert, Paine, Stacy, Johnson, Macy, Barrios, John, Eppensteiner, Alexander, Limkakeng, Lauren, McGowan, Tedra, Porter, Andrew, Bouffler, J. Clancy, Leahy, Bennet, deBoisblanc, Matthew, Lammi, Kyle, Happel, Paula, Lauto, Wesley, Self, Jonathan, Casey, Matthew, Semler, Sean, Collins, Frank, Harrell, Christopher, Lindsell, Todd, Rice, William, Stubblefield, Christopher, Gray, Jakea, Johnson, Megan, Roth, Margaret, Hays, Donna, Torr, Arwa, Zakaria, David, Schoenfeld, Taylor, Thompson, Douglas, Hayden, Nancy, Ringwood, Cathryn, Oldmixon, Christine, Ulysse, Richard, Morse, Ariela, Muzikansky, Laura, Fitzgerald, Samuel, Whitaker, Adrian, Lagakos, Roy, Brower, Lora, Reineck, Neil, Aggarwal, Karen, Bienstock, Michelle, Freemer, Myron, Maclawiw, Gail, Weinmann, Laurie, Morrison, Mark, Gillespie, Richard, Kryscio, Daniel, Brodie, Wojciech, Zareba, Anne, Rompalo, Michael, Boeckh, Polly, Parsons, Jason, Christie, Jesse, Hall, Nicholas, Horton, Laurie, Zoloth, Neal, Dickert, and Deborah, Diercks

Subjects
Adult, Male, medicine.medical_specialty, Randomization, Science, Pneumonia, Viral, Placebo, 01 natural sciences, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Interquartile range, Internal medicine, medicine, Humans, Treatment Failure, 030212 general & internal medicine, 0101 mathematics, Pandemics, Aged, Original Investigation, business.industry, SARS-CoV-2, 010102 general mathematics, Politics, Hydroxychloroquine, General Medicine, Odds ratio, Middle Aged, Interim analysis, Intensive care unit, COVID-19 Drug Treatment, Female, business, medicine.drug
Abstract

Importance Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed. Objective To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19. Design, Setting, and Participants This was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients. Interventions Patients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237). Main Outcomes and Measures The primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality. Results Among 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, −0.2% [95% CI, −5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]). Conclusions and Relevance Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults. Trial Registration ClinicalTrials.gov:NCT04332991

Published
2020

3. Treating Decompression Sickness: Military Flight Simulation Site–Community Hospital Partnership

Author

Kathleen Flarity, Tracy Cushing, George Hertner, Lani Finck, Whitney C. Rhodes, Claudia Temmer, and Robert Price

Subjects
Adult, Male, 030110 physiology, 0301 basic medicine, Pathology, medicine.medical_specialty, Colorado, Adolescent, Supplemental oxygen, Hospitals, Community, Public-Private Sector Partnerships, Flight simulator, Military medicine, Decompression sickness, 03 medical and health sciences, medicine, Humans, Hyperbaric Oxygenation, business.industry, Teaching, Public Health, Environmental and Occupational Health, General Medicine, Decompression Sickness, medicine.disease, Emergency situations, Community hospital, Navy, General partnership, Aerospace Medicine, Female, Medical emergency, business
Abstract

High-altitude flight simulation familiarizes military trainees with the symptoms of hypoxia to prepare them for emergency situations. Decompression sickness (DCS) can occur as a result of these simulations. In cases when ground-level supplemental oxygen does not resolve symptoms, hyperbaric oxygen (HBO) therapy is indicated. Many military hyperbaric chambers have been closed because of cost reductions, necessitating partnerships with community hospitals to ensure access to treatment.This article describes the unique arrangement between a community hospital in Colorado and a military training site to treat DCS cases emergently. We gathered cost data from the community hospital to estimate and compare the cost of providing HBO therapy in the hospital versus a standalone chamber similar to the former military hyperbaric chamber.Since the closure of the military hyperbaric chamber, the community hospital treated an estimated 50 patients with DCS requiring HBO therapy attributed to high-altitude flight simulation between October 2003 and April 2015. Cost to the institution providing HBO treatment varies widely on the basis of patient volume. Assuming a volume of five treatments, per-treatment cost at a standalone center is $95,380. In contrast, per-treatment cost at the hospital assuming a volume of 1,000 treatments commensurate with the hospital's ability to bill for other services is $698 per treatment.The cost analysis demonstrates that the per-treatment cost of operating a standalone HBO therapy center may be greater than 100 times that of operating a center at a community hospital, suggesting the arrangement is beneficial to the military.

Published
2017
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4. Early High-Dose Vitamin D

Author

Adit A, Ginde, Roy G, Brower, Jeffrey M, Caterino, Lani, Finck, Valerie M, Banner-Goodspeed, Colin K, Grissom, Douglas, Hayden, Catherine L, Hough, Robert C, Hyzy, Akram, Khan, Joseph E, Levitt, Pauline K, Park, Nancy, Ringwood, Emanuel P, Rivers, Wesley H, Self, Nathan I, Shapiro, B Taylor, Thompson, Donald M, Yealy, and Laurie S, Zoloth

Subjects
Vitamin, Adult, Male, medicine.medical_specialty, Organ Dysfunction Scores, Critical Illness, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Gastroenterology, vitamin D deficiency, Treatment failure, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Double-Blind Method, Internal medicine, medicine, Vitamin D and neurology, Humans, 030212 general & internal medicine, Treatment Failure, Vitamin D, Cholecalciferol, Extramural, business.industry, Critically ill, General Medicine, Vitamins, Length of Stay, Middle Aged, medicine.disease, Vitamin D Deficiency, Clinical trial, Multicenter study, chemistry, Female, business
Abstract

BACKGROUND: Vitamin D deficiency is a common, potentially reversible contributor to morbidity and mortality among critically ill patients. The potential benefits of vitamin D supplementation in acute critical illness require further study. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 3 trial of early vitamin D(3) supplementation in critically ill, vitamin D-deficient patients who were at high risk for death. Randomization occurred within 12 hours after the decision to admit the patient to an intensive care unit. Eligible patients received a single enteral dose of 540,000 IU of vitamin D(3) or matched placebo. The primary end point was 90-day all-cause, all-location mortality. RESULTS: A total of 1360 patients were found to be vitamin D-deficient during point-of-care screening and underwent randomization. Of these patients, 1078 had baseline vitamin D deficiency (25-hydroxyvitamin D level

Published
2019

5. A single-site pilot implementation of a novel trauma training program for prehospital providers in a resource-limited setting

Author

Lani Finck, Russell E. Glasgow, Nee-Kofi Mould-Millman, Edward P. Havranek, Kubendhren Moodley, Andrew Lamp, Amanda Skenadore, Adit A. Ginde, Shaheem de Vries, Vikhyat S. Bebarta, Kathryn L. Colborn, Brenda L. Beaty, and Julia Dixon

Subjects
Global health, MEDLINE, Psychological intervention, Medicine (miscellaneous), Effectiveness, Feasibility study, Trauma, Education, Resource-limited, 03 medical and health sciences, 0302 clinical medicine, Intervention (counseling), Emergency medical services, Medicine, 030212 general & internal medicine, Prospective cohort study, Prehospital, Pilot study, lcsh:R5-920, Pilot implementation, business.industry, Research, 030208 emergency & critical care medicine, medicine.disease, 3. Good health, Facilitator, Implementation science, Medical emergency, lcsh:Medicine (General), business
Abstract

Background Prehospital (ambulance) care can reduce morbidity and mortality from trauma. Yet, there is a dearth of effective evidence-based interventions and implementation strategies. Emergency Medical Services Traumatic Shock Care (EMS-TruShoC) is a novel bundle of five core evidence-based trauma care interventions. High-Efficiency EMS Training (HEET) is an innovative training and sensitization program conducted during clinical shifts in ambulances. We assess the feasibility of implementing EMS-TruShoC using the HEET strategy, and feasibility of assessing implementation and clinical outcomes. Findings will inform a main trial. Methods We conducted a single-site, prospective cohort, multi-methods pilot implementation study in Western Cape EMS system of South Africa. Of the 120 providers at the study site, 12 were trainers and the remaining were eligible learners. Feasibility of implementation was guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Feasibility of assessing clinical outcomes was assessed using shock indices and clinical quality of care scores, collected via abstraction of patients’ prehospital trauma charts. Thresholds for progression to a main trial were developed a priori. Results The average of all implementation indices was 83% (standard deviation = 10.3). Reach of the HEET program was high, with 84% learners completing at least 75% of training modules. Comparing the proportion of learners attaining perfect scores in post- versus pre-implementation assessments, there was an 8-fold (52% vs. 6%) improvement in knowledge, 3-fold (39% vs. 12%) improvement in skills, and 2-fold (42% vs. 21%) increase in self-efficacy. Clinical outcomes data were successfully calculated—there were clinically significant improvements in shock indices and quality of prehospital trauma care in the post- versus pre-implementation phases. Adoption of HEET was good, evidenced by 83% of facilitator participation in trainings, and 100% of surveyed stakeholders indicating good programmatic fit for their organization. Stakeholders responded that HEET was a sustainable educational solution that aligned well with their organization. Implementation fidelity was very high; 90% of the HEET intervention and 77% of the implementation strategy were delivered as originally planned. Participants provided very positive feedback, and explained that on-the-job timing enhanced their participation. Maintenance was not relevant to assess in this pilot study. Conclusions We successfully implemented the EMS-TruShoC educational intervention using the HEET training strategy in a single-site pilot study conducted in a low-resource international setting. All clinical outcomes were successfully calculated. Overall, this pilot study suggests high feasibility of our future, planned experimental trial.

Published
2019
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