At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of sickle cell disease
- ✓Age birth to 5 years, inclusive
- ✓Eligible for hydroxyurea based on genotype (SS, Sβ0Thal) or other genotype with clinical complications
- ✓Child's parent, legal guardian, or designated decision maker must participate in both study visits
- ✕Parent/legal guardian has previously been approached about or made a decision regarding hydroxyurea initiation
- ✕Any other diagnosis or condition that, in the investigator's or hematologist's opinion, makes the patient unsuitable for the study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)
In Brief
A clinical study evaluating Hydroxyurea SDM Toolkit and Clinician Pocket Guide for Sickle Cell Anemia and Children, Only. Completed, enrolled 176 participants across 11 sites.
Detailed Summary
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 Details
Timeline
Interventions
Implementation tools and visit decision aids
current hydroxyurea protocol and ASH pocket guide