Shared-Decision Making for Hydroxyurea

Children, Only Clinical Trial

— ENGAGE-HU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03442114
• Other study ID #: CDR_1609_36055
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2018
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2022
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Yolanda Johnson, MLS
• Phone: 5138030918
• Email: engagehu[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 5 Years

Eligibility

Inclusion Criteria:

1. Diagnosis: sickle cell disease

2. Age: birth-5 years, inclusive

3. Eligible for hydroxyurea (genotype SS, Sß0Thal or other genotype + clinical complications)

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.

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Children, Only
• Sickle Cell Anemia

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Ann & Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana Hemophilia & Thrombosis Center	Indianapolis	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	UCSF Beinoff Children's Hospital and Research Center at Oakland	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	The Washington University	Saint Louis	Missouri
United States	Howard University	Washington	District of Columbia
United States	Nemours Children's Health	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decisional conflict	Decisional Conflict Scale (DCS)	up to 4 weeks
Secondary	Shared decision making	Dyadic OPTION	up to 4 weeks
Secondary	Hydroxyurea offered	electronic medical record (EMR) data	From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 months