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The problem
Intervention: Engage-HU randomized controlled trial testing two dissemination methods for clinicians to facilitate shared decision-making with caregivers about hydroxyurea, with additional measurement of COVID-19 pandemic impacts and telemedicine usability
Who it was tested with: Caregivers of children aged 0-5 years with sickle cell disease (HbSS or HbSβ0 thalassemia) who are candidates for hydroxyurea and have not decided about treatment in the past 3 months; primarily African American/Black mothers in the United States.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"Engage-HU is a randomized control trial comparing two dissemination methods for clinicians to facilitate shared decision-making with caregivers of young children with SCD. Study outcomes include caregiver confidence in decision-making and perceptions of experiencing shared decision-making as well as HU uptake and child health outcomes." The trial is designed to evaluate whether different clinician-led approaches to shared decision-making improve caregiver confidence and HU treatment uptake, but pandemic disruptions and preliminary cross-sectional correlational data on distress and telemedicine satisfaction do not yet provide definitive evidence on the intervention's effectiveness for the primary outcomes.
Preliminary analysis based on 48 of target 174 caregivers enrolled; cross-sectional association measures do not establish causation; ongoing data collection means long-term intervention effects on hydroxyurea uptake and child health outcomes cannot yet be determined.
Across countries and designs
1 study · 1 country
