A randomized controlled trial comparing two vaso-occlusive episode (VOE) protocols in sickle cell disease (SCD).

Abstract

Limited evidence guides opioid dosing strategies for acute Sickle Cell (SCD) pain. We compared two National Heart, Lung and Blood (NHBLI) recommended opioid dosing strategies (weight-based vs. patient-specific) for ED treatment of acute vaso-occlusive episodes (VOE). A prospective randomized controlled trial (RCT) was conducted in two ED's. Adults ≥ 21 years of age with SCD disease were eligible. Among the 155 eligible patients, 106 consented and 52 had eligible visits. Patients were pre-enrolled in the outpatient setting and randomized to one of two opioid dosing strategies for a future ED visit. ED providers accessed protocols through the electronic medical record. Change in pain score (0-100 mm VAS) from arrival to ED disposition, as well as side effects were assessed. 52 patients (median age was 27 years, 42% were female, and 89% black) had one or more ED visits for a VOE (total of 126 ED study visits, up to 5 visits/patient were included). Participants randomized to the patient-specific protocol experienced a mean reduction in pain score that was 16.6 points greater than patients randomized to the weight-based group (mean difference 95% CI = 11.3 to 21.9, P = 0.03). Naloxone was not required for either protocol and nausea and/or vomiting was observed less often in the patient-specific protocol (25.8% vs 59.4%, P = 0.0001). The hospital admission rate for VOE was lower for patients in the patient-specific protocol (40.3% vs 57.8% P = 0.05). NHLBI guideline-based analgesia with patient-specific opioid dosing resulted in greater improvements in the pain experience compared to a weight-based strategy, without increased side effects.

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Citation

Published Version (Please cite this version)

10.1002/ajh.24948

Publication Info

Tanabe, Paula, Susan Silva, Hayden B Bosworth, Regina Crawford, Judith A Paice, Lynne D Richardson, Christopher N Miller, Jeffrey Glassberg, et al. (2018). A randomized controlled trial comparing two vaso-occlusive episode (VOE) protocols in sickle cell disease (SCD). American journal of hematology, 93(2). pp. 159–168. 10.1002/ajh.24948 Retrieved from https://hdl.handle.net/10161/29893.

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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.

Susan Gray Silva

Associate Research Professor in the School of Nursing

Dr. Silva is an Associate Research Professor in the Duke University School of Nursing and School of Medicine, with specialty training in neurobehavioral assessment, cognitive neuropsychology, and biostatistics. Within the PhD Program in the School of Nursing, Dr. Silva mentors students and teaches courses in General Linear Models, Generalized Linear Mixed Models, Mediator and Moderator Analyses, and Longitudinal Data Analysis. She also teaches a course in Quantitative Methods for Evaluating Health Care Practices course in the Doctor of Nursing Practices program and guides students in the design and analysis of quality improvement projects and implementation science studies.

Prior to joining the faculty in the School of Nursing in August 2009, Dr. Silva was a faculty statistician in the Clinical Trials Statistics Group and a mental health researcher in the Division of Neurosciences at Duke Clinical Research Institute (DCRI) and the Division of Medical Psychology in the Department of Psychiatry and Behavioral Sciences at Duke. While at DCRI, her focus was on the design and analysis of multi-center neuropsychiatric clinical trials.

Before coming to Duke in 1999, Dr. Silva was the Director of the Neurobehavioral Assessment Core and Associate Director of the Data Management & Biostatistics Core for the National Institute of Mental Health-funded Neuroscience Clinical Research Center at the University of North Carolina-Chapel Hill.

Dr. Silva served as the Statistical PI for the NIMH’s Treatment for Adolescents with Depression Study (TADS), NIMH’s Substance Use Outcomes Following Treatment for Adolescent Depression (SOFTAD) study, NIMH’s Child and Adolescent Psychiatry Trials Network (CAPTN). She was a statistical co-investigator for NIDA’s National Drug Abuse Treatment Clinical Trials Network (CTN), NICHD’s Reproductive Medicine Network (RMN), and SAMHSA’s National Center for Child Traumatic Stress. Dr. Silva has been a member of the NIMH's Data and Safety Board for Child and Adolescent Interventions and Health Services since 2002.

As a researcher and statistician, Dr. Silva's focus has been on the application of (1) multi-level mixed-effects trajectory models for longitudinal data, (2) ecological momentary assessment; (3) moderator and mediator analyses, and (4) structural equation modeling for complex moderated mediation analyses.
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


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