Shared-Decision Making for Hydroxyurea

Completed · Not applicable

Conditions studied: Sickle Cell Anemia, Children, Only

In brief

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). The study 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. The investigators hope that both methods lead to parents reaching a high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. The researchers 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 higher quality of life. The project team hopes to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision.

Key facts

Study ID

NCT03442114

Run by

Children's Hospital Medical Center, Cincinnati

People needed

176

Starts

2018-07-12

Expected to finish

2022-02-28

Last updated by the study team

2025-06-13

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis: sickle cell disease
• Age: birth-5 years, inclusive
• Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical complications)
• Child's parent, legal guardian, or designated decision maker (caregiver) must participate in both study visits
• Child's parent, legal guardian, or designated decision maker (caregiver) must able to read, understand, and speak English

You may not qualify if…

• Parent/legal guardian has previously been approached OR made a decision about whether to initiate hydroxyurea.
• Any and all other diagnoses or conditions which, in the opinion of the site investigator or hematologist, would prevent the patient from being a suitable candidate for the study.

Where it is running

• UCSF Beinoff Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Nemours Children's Health — Wilmington, Delaware, United States
• Howard University — Washington D.C., District of Columbia, United States
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• The Washington University — St Louis, Missouri, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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