Shared-Decision Making for Hydroxyurea

Conditions

• Children, Only
• Sickle Cell Anemia

Eligibility Criteria

Sex

ALL

Age

1 Month - 5 Years

Healthy Volunteers

Not accepted

Interventions

• Hydroxyurea SDM Toolkit — BEHAVIORAL
  Implementation tools and visit decision aids
• Clinician Pocket Guide — BEHAVIORAL
  current hydroxyurea protocol and ASH pocket guide

Study Details

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.

Key Dates

Start date

Jul 12, 2018

Status verified

Jun 2025

Primary completion

Feb 28, 2022

Completion

Feb 28, 2022

Study Design

Enrollment

176 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Hydroxyurea SDM Toolkit (H-SDM)
  During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea).
• Active Comparator: Clinician Pocket Guide
  In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.'

Primary Outcome Measure

Decisional Conflict [ Time Frame: Baseline - after shared discussion with clinician ]

Locations (11)

Find similar trials in Oakland, CA

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