Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)

About the study

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.

Study point of contact

Naima Griffin
[email protected]
Yolanda Johnson, MLS
[email protected]


8 United States sites


1 to 5 Years



Study type








participation requirements

1. Diagnosis: sickle cell disease

2. Age: birth-5 years, inclusive

3. Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical

4. Child’s parent, legal guardian, or designated decision maker (caregiver) must
participate in both study visits

5. Child’s parent, legal guardian, or designated decision maker (caregiver) must able to
read, understand, and speak English

participation restrictions

1. Parent/legal guardian has previously been approached OR made a decision about whether
to initiate hydroxyurea.

2. 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.


  • Oakland, California, United States, Children's Hospital and Research Center at Oakland, 94609 [Not yet recruiting]
  • Washington, District of Columbia, United States, Howard University, 20060 [Recruiting]
  • Chicago, Illinois, United States, Ann & Robert H Lurie Children's Hospital of Chicago, 60611 [Not yet recruiting]
  • Saint Louis, Missouri, United States, The Washington University, 63110 [Not yet recruiting]
  • Columbus, Ohio, United States, Nationwide Children's Hospital, 43205 [Recruiting]
  • Philadelphia, Pennsylvania, United States, Children's Hospital of Philadelphia, 19104 [Not yet recruiting]
  • Nashville, Tennessee, United States, Vanderbilt University Medical Center, 37232 [Not yet recruiting]
  • Houston, Texas, United States, Baylor College of Medicine, 77030 [Not yet recruiting]
Last updated 2020-11-30