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Engaging parents of children with sickle cell anemia and their providers in shared decision making for hydroxyurea
Investigator (PI): Crosby, Lori E
Performing Organization (PO): (Current): Cincinnati Children's Hospital Medical Center, Division of Behavioral Medicine and Clinical Psychology / (513) 636-4336
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2017
Final Year: 2022
Record Source/Award ID: PCORI/CDR-1609-36055
Funding: Total Award Amount: $1,962,454
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Description of the problem the project seeks to solve: Nearly 1 in 2500 babies born annually in the United States has sickle cell disease, a genetic blood disorder that can cause severe pain, chronic organ damage, and early death. Hydroxyurea is a medication that can significantly improve the disease. Patients who take hydroxyurea have less pain and fewer medical complications, and live longer. National guidelines state that hydroxyurea should be offered to children as early as 9 months of age using shared decision making, but parents have concerns about the medication's safety and long-term side effects. In addition, clinicians lack tools to facilitate a shared discussion with parents. As a result, parents are less likely to start their child on hydroxyurea, and, when they do, many parents experience anxiety about whether they made the right decision. Outcomes we hope to achieve: The goal of the 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 takes into account medical evidence and parent values and preferences). We will compare two methods to help clinicians facilitate this--a clinician pocket guide and a clinician hydroxyurea shared decision making toolkit--in a group of parents of children ages 0-5 with sickle cell disease. We hope that both methods lead to parents reaching a high-quality informed decision. In addition, we hope to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. We also expect these parents to be more likely to choose hydroxyurea and that their children will have less pain, fewer hospitalizations, better developmental outcomes, and high quality of life. We hope to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision. Why this project is important to patients: This project is important to parents/patients because making a bad decision about treatments can have serious consequences for the child's health and well-being. This project is likely to improve the quality of care provided to young children with sickle cell disease. Explanation of how patients and other stakeholders will help make the project successful: Parent and stakeholder partners have worked with the research team to plan the study. They helped to frame the research question and selected the outcomes most important to their families. These stakeholders will continue to advise on the overall study and monitor study progress and risks. One parent or community stakeholder from each site will work with the Sickle Cell Disease Association of America to develop strategies to share study results locally and nationally. Having the input of parents and stakeholders in the design, conduct, and management of the study will maximize recruitment success and the applicability of study findings to other settings.
MeSH Terms:
  • Anemia, Sickle Cell /*drug therapy
  • /psychology
  • Child, Preschool
  • Communication
  • Decision Making
  • Family Health
  • Guidelines as Topic
  • Humans
  • Hydroxyurea /*therapeutic use
  • Infant
  • Infant, Newborn
  • Outcome Assessment, Health Care
  • * Parents
  • Physician-Patient Relations
  • Program Development
  • Program Evaluation
  • Quality of Life
  • Reproducibility of Results
  • United States
Country: United States
State: Ohio
Zip Code: 45229
UI: 20181455
CTgovId: NCT03442114
Project Status: Ongoing
Record History: ('2018: Project extended to 2021.',)