A Comparison of the effect of patient-specific vs. weight-based protocols to treat vaso-occlusive episodes (VOE) in the emergency department.

Abstract

Background

Vaso-occlusive episodes (VOC) cause debilitating pain and are a common cause of emergency department (ED) visits, for people with sickle cell disease (SCD). Strategies for achieving optimal pain control vary widely despite evidence-based guidelines. We tested existing guidelines and hypothesized a patient-specific protocol (PSP) written by their SCD provider, may be more effective than weight-based (WB) dosing of parenteral opiate medication, in relieving pain.

Methods

Prospective, randomized controlled trial comparing a PSP versus WB protocol for patients presenting with VOC to six EDs. Patients were randomized to a PSP or WB protocol prior to an ED visit. SCD provider wrote their protocol and placed in the electronic health record for future ED visits with a VOC Exclusion criteria included: pre-existing PSP excluding parenteral opioid analgesia or out-patient use of buprenorphine or methadone, or highly suspected for COVID-19. Pain intensity scores, side effects and safety were obtained every 30 minutes for up to 6 hours post-ED bed placement. The primary outcome was change in pain intensity score from placement in an ED space to disposition or six hours.

Results

328 subjects were randomized, 104 participants enrolled (ED visit, target n=230) with complete data for 96 visits. The study was unable to reach the target sample size and stopped early due to the impact of COVID-19. We found no significant differences between groups in the primary outcome; patients randomized to a PSP had a shorter ED length of stay (p=.008); the prevalence of side effects was low in both groups. Subjects in both groups experienced both a clinically meaningful and statistically significant decrease in pain (27 mm on a 0-100 mm scale) CONCLUSIONS: We found a shorter ED length of stay for patients assigned to a PSP. Patients in both groups experienced good pain relief without significant side effects.

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Citation

Published Version (Please cite this version)

10.1111/acem.14805

Publication Info

Tanabe, Paula, Stephanie Ibemere, Ava E Pierce, Caroline E Freiermuth, Hayden B Bosworth, Hongqui Yang, Ifeyinwa Osunkwo, James H Paxton, et al. (2023). A Comparison of the effect of patient-specific vs. weight-based protocols to treat vaso-occlusive episodes (VOE) in the emergency department. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine. 10.1111/acem.14805 Retrieved from https://hdl.handle.net/10161/29342.

This is constructed from limited available data and may be imprecise. To cite this article, please review & use the official citation provided by the journal.

Scholars@Duke

Tanabe

Paula J Tanabe

Laurel Chadwick Distinguished Professor of Nursing

Dr. Tanabe is the Laurel B. Chadwick Distinguished Professor in the Schools of Nursing and Medicine at Duke at the Duke University School of Nursing. Dr. Tanabe is a clinical and health services researcher. Her program of research focuses on improving systems of healthcare and patient outcomes for persons with sickle cell disease, a primarily minority and under-served population. Dr. Tanabe has received funding from the Agency for Health Care Research and Quality, the National Institute of Heart, Lung, and Blood, National Institute of Minority Health and Health Disparities and the National Institute of Nursing Research. Her work is advancing the care of individuals with sickle cell disease with a strong focus on improving pain management in the emergency department during a vaso-occlusive crisis. Her methodological expertise includes conducting multi-site clinical RCT’s, survey methods, qualitative research, quality improvement and implementation science. Dr. Tanabe has a strong passion for her work, individuals with sickle cell disease, and for mentoring students and faculty to conduct important, meaningful work to improve the health and well being of individuals and families.

Bosworth

Hayden Barry Bosworth

Professor in Population Health Sciences

Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT)  at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities. 

Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.

Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy

Strouse

John J. Strouse

Associate Professor of Medicine

My research has focused on the epidemiology, risk factors, and prevention of the pulmonary and central nervous system complications of sickle cell disease and includes retrospective and prospective cohort studies and clinical trials.  I received my Ph.D. in clinical investigation from the Johns Hopkins Bloomberg School of Public Health for a series of studies to identify predictors of cognitive function in children with sickle cell disease.  This work has expanded to the evaluation of the interaction between environment and disease in both children and adults and the functional evaluation of adults with sickle cell disease.  My other research interests include the application of large clinical, research, and administrative databases to the study of rare hematological diseases and interventions to improve quality of and access to care for sickle cell disease. I serve on the American Society of Hematology Sickle Cell Taskforce and Sickle Cell Pain Guideline Panel and am co-chair of the American Society of Hematology Healthcare Professional Education and Training Work Group.

 

Barnhart

Huiman Xie Barnhart

James B. Duke Distinguished Professor

My research interests include both statistical methodology and disease-specific clinical research biostatistics. My statistical research areas include methods for outcomes, endpoints, estimands, assessing reliability/agreement between methods or raters, evaluating performance of new medical diagnostic tests, and methods for design of clinical trials. My collaborative research include the following clinical areas: liver injury, cardiovascular imaging, radiology imaging, cardiovascular disease, renal disease, reproductive medicine, Parkinson disease, and aging.


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