Title

Engaging caregivers and providers of children with sickle cell anemia in shared decision making for hydroxyurea: Protocol for a multicenter randomized controlled trial

Authors

Anna M. Hood, UCL Great Ormond Street Institute of Child Health
Heather Strong, Cincinnati Children's Hospital Medical Center
Cara Nwankwo, Oklahoma State University
Yolanda Johnson, Cincinnati Children's Hospital Medical Center
James Peugh, Cincinnati Children's Hospital Medical Center
Constance A. Mara, Cincinnati Children's Hospital Medical Center
Lisa M. Shook, University of Cincinnati College of Medicine
William B. Brinkman, University of Cincinnati College of Medicine
Francis J. Real, University of Cincinnati College of Medicine
Melissa D. Klein, University of Cincinnati College of Medicine
Rogelle Hackworth, Cincinnati Children's Hospital Medical Center
Sherif M. Badawy, Northwestern University Feinberg School of Medicine
Alexis A. Thompson, Northwestern University Feinberg School of Medicine
Jean L. Raphael, Baylor College of Medicine
Amber M. Yates, Baylor College of Medicine
Kim Smith-Whitley, The Children's Hospital of Philadelphia
Allison A. King, St. Louis Children's Hospital
Cecelia Calhoun, Washington University School of Medicine in St. Louis
Susan E. Creary, Nationwide Children’s Hospital
Connie M. Piccone, University Hospitals Rainbow Babies & Children's Hospital
Aimee K. Hildenbrand, Alfred I. duPont Hospital for Children
Steven K. Reader, Alfred I. duPont Hospital for Children
Lynne Neumayr, UCSF Benioff Children's Hospital Oakland
Emily R. Meier, Indiana Hemophilia and Thrombosis Center
Amy E. Sobota, Boston Medical Center
Sohail Rana, Howard University College of Medicine
Maria Britto, University of Cincinnati College of Medicine
Kay L. Saving, University of Illinois College of Medicine
Marsha Treadwell, UCSF Benioff Children's Hospital Oakland
Charles T. Quinn, University of Cincinnati College of Medicine
Russell E. Ware, University of Cincinnati College of Medicine
Lori E. Crosby, Cincinnati Children's Hospital Medical Center

Document Type

Article

Publication Date

5-1-2021

Abstract

Background: Sickle cell anemia (SCA) is a genetic blood disorder that puts children at a risk of serious medical complications, early morbidity and mortality, and high health care utilization. Until recently, hydroxyurea was the only disease-modifying treatment for this life-threatening disease and has remained the only option for children younger than 5 years. Evidence-based guidelines recommend using a shared decision-making (SDM) approach for offering hydroxyurea to children with SCA (HbSS or HbS/β0 thalassemia) aged as early as 9 months. However, the uptake remains suboptimal, likely because caregivers lack information about hydroxyurea and have concerns about its safety and potential long-term side effects. Moreover, clinicians do not routinely receive training or tools, especially those that provide medical evidence and consider caregivers' preferences and values, to facilitate a shared discussion with caregivers. Objective: The aim of this study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that considers medical evidence and parent values and preferences). Methods: We designed our study to compare the effectiveness of two methods for disseminating hydroxyurea guidelines to facilitate SDM: a clinician pocket guide (ie, usual care) and a clinician hydroxyurea SDM toolkit (H-SDM toolkit). Our primary outcomes are caregiver reports of decisional uncertainty and knowledge of hydroxyurea. The study also assesses the number of children (aged 0-5 years) who were offered and prescribed hydroxyurea and the resultant health outcomes. Results: The Ethics Committee of the Cincinnati Children's Hospital Medical Center approved this study in November 2017. As of February 2021, we have enrolled 120 caregiver participants. Conclusions: The long-term objective of this study is to improve the quality of care for children with SCA. Using multicomponent dissemination methods developed in partnership with key stakeholders and designed to address barriers to high-quality care, caregivers of patients with SCA can make informed and shared decisions about their health.

This document is currently not available here.

Share

COinS