Shared-Decision Making for Hydroxyurea

Conditions:Anemia, Anemia
Therapuetic Areas:Hematology
Age Range:Any - 5
Start Date:July 12, 2018
End Date:November 30, 2020
Contact:Rhemecka Graham

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

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.

Sickle cell disease (SCD) is a genetic blood disorder that places children at risk for
serious medical complications, early morbidity and mortality, and high healthcare
utilization. In the U.S., SCD primarily affects African-American and Latino children.
Hydroxyurea is one of the only disease-modifying treatment for this devastating and
life-threatening disease. National Evidence-Based Guidelines recommend the use of a shared
decision making approach to offer hydroxyurea to all children with SCD as early as nine
months of age. Hydroxyurea uptake remains low because parents lack information about
hydroxyurea and have concerns about its safety and potential long-term side effects (e.g.
cancer, infertility, birth defects). Clinicians do not have the training or tools to
facilitate a shared discussion with parents that provides medical evidence and considers
parent preferences and values. The current study compares two methods for disseminating
hydroxyurea guidelines and facilitating shared decision-making: the American Society of
Hematology's hydroxyurea clinician pocket guide (usual care method) and a clinician
hydroxyurea shared decision-making toolkit (H-SDM toolkit). The specific aims of the study
are to evaluate the effectiveness of the usual care dissemination method (clinician pocket
guide) and the H-SDM clinician toolkit dissemination method on: parent report of decisional
uncertainty (primary outcome chosen by parents of children with SCD), parent perception of
experiencing shared decision-making, parent knowledge of hydroxyurea, the number of children
offered hydroxyurea, hydroxyurea uptake (those with active prescriptions), and child health
outcomes (pain, neurocognitive functioning, sickle cell related quality of life and
healthcare utilization). Eligible children must be between the ages of 0 and 5 and a
candidate for hydroxyurea to participate. The trial will use a stepped-wedge design (clinic
is the unit of randomization). The long-term objective of the research team is to improve the
quality of care for children with SCD. The investigators propose that suboptimal care for
patients with SCD is preventable with the use of multicomponent dissemination methods if
developed with key stakeholders and designed to address barriers to high quality care at
multiple levels (patient, clinician, healthcare system, and community).

Inclusion Criteria:

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

Exclusion Criteria:

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.
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