Trial results for a study on shared decision-making for hydroxyurea in pediatric sickle cell disease were posted on ClinicalTrials.gov on 2025-05-25. The study compared two methods to facilitate shared discussions, with the Hydroxyurea Shared Decision Making (H-SDM) Toolkit generally showing lower mean decisional conflict scores, reaching as low as 16.8 on a scale.
Background
Sickle Cell Disease, specifically Sickle Cell Anemia in young children, is a genetic blood disorder requiring careful management. Hydroxyurea is a key treatment option, and informed decision-making by parents is crucial. This study aimed to evaluate methods for facilitating shared discussions between clinicians and parents of young children with sickle cell disease regarding hydroxyurea treatment. The goal was to help parents reach high-quality, well-informed decisions that consider both medical evidence and their personal values and preferences.
Trial design
This study, designated as "NA" phase, enrolled 176 participants. The trial focused on children aged 0-5 with Sickle Cell Anemia. The study compared two methods designed to help clinicians facilitate shared decision-making: a Clinician Pocket Guide and a Clinician Hydroxyurea Shared Decision Making Toolkit (H-SDM). The investigators aimed to understand how these methods could best assist parents and clinicians in having shared discussions about hydroxyurea.
Key results
The study measured "Decisional Conflict" using a score on a scale across various instances:
- For the "Clinician Pocket Guide" group, mean decisional conflict scores were:
- 22.9 (Standard Deviation 20.3)
- 26.9 (Standard Deviation 25.4)
- 20.8 (Standard Deviation 20.2)
- 23.3 (Standard Deviation 24.4)
- 21.2 (Standard Deviation 24.4)
- 22.3 (Standard Deviation 21.0)
- For the "Hydroxyurea SDM Toolkit (H-SDM)" group, mean decisional conflict scores were:
- 19.8 (Standard Deviation 17.1)
- 23.5 (Standard Deviation 21.5)
- 16.8 (Standard Deviation 14.4)
- 21.0 (Standard Deviation 21.1)
- 17.9 (Standard Deviation 16.8)
- 19.6 (Standard Deviation 20.3)
What this means
The results suggest that the Hydroxyurea Shared Decision Making (H-SDM) Toolkit may be a more effective tool for reducing decisional conflict among parents of young children with sickle cell disease when discussing hydroxyurea treatment. Consistently lower mean decisional conflict scores were observed in the H-SDM Toolkit group compared to the Clinician Pocket Guide group. This indicates that the H-SDM Toolkit could better support parents in navigating complex treatment decisions, potentially leading to more informed and value-concordant choices.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03442114, titled "Shared-Decision Making for Hydroxyurea", were posted on 2025-05-25 on clinicaltrials.gov.