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Shared-Decision Making for Hydroxyurea (ENGAGE-HU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03442114
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Children, Only Behavioral: Hydroxyurea SDM Toolkit Behavioral: Clinician Pocket Guide Not Applicable

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped Wedge Randomized Clinical Trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)
Actual Study Start Date : July 12, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
Drug Information available for: Hydroxyurea

Arm Intervention/treatment
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).
Behavioral: Hydroxyurea SDM Toolkit
Implementation tools and visit decision aids

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.'
Behavioral: Clinician Pocket Guide
current hydroxyurea protocol and ASH pocket guide




Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: up to 4 weeks ]
    Decisional Conflict Scale (DCS)


Secondary Outcome Measures :
  1. Shared decision making [ Time Frame: up to 4 weeks ]
    Dyadic OPTION

  2. Hydroxyurea offered [ Time Frame: From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 months ]
    electronic medical record (EMR) data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis: sickle cell disease
  2. Age: birth-5 years, inclusive
  3. Eligible for hydroxyurea (genotype SS, Sβ0Thal 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442114


Contacts
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Contact: Yolanda Johnson, MLS 5138030918 engagehu@cchmc.org
Contact: Naima Griffin 5136360000 engagehu@cchmc.org

Locations
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United States, California
UCSF Beinoff Children's Hospital and Research Center at Oakland Recruiting
Oakland, California, United States, 94609
Contact: Lynne Neumayr, MD         
United States, Delaware
Nemours Children's Health Recruiting
Wilmington, Delaware, United States, 19803
Contact: Steven Reader, PhD         
Principal Investigator: Steven Reader, PhD         
United States, District of Columbia
Howard University Terminated
Washington, District of Columbia, United States, 20060
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Sherif Badawy, MD         
Sub-Investigator: Sherif Badawy, MD         
United States, Indiana
Indiana Hemophilia & Thrombosis Center Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Angeli Rampersad, MD         
Principal Investigator: Angeli Rampersad, MD         
United States, Massachusetts
Boston Children's Hospital Completed
Boston, Massachusetts, United States, 02118
United States, Missouri
The Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Allison King, MD         
Sub-Investigator: Cecelia Calhoun, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Susan Creary, MD         
Principal Investigator: Susan Creary, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Alexis Thompson, MD         
Principal Investigator: Alexis Thompson, MD         
United States, Tennessee
Vanderbilt University Medical Center Terminated
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Jean Raphael, MD         
Sub-Investigator: Amber Yates, MD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Lori E Crosby, PsyD Children's Hospital Medical Center, Cincinnati
  Study Documents (Full-Text)

Documents provided by Children's Hospital Medical Center, Cincinnati:
Informed Consent Form  [PDF] November 16, 2017

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03442114    
Other Study ID Numbers: CDR_1609_36055
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This study will comply with the Patient Centered Outcomes Research Institute (PCORI) Public Access Policy, which ensures that the public has access to the published results of PCORI funded research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
shared decision making
parent-provider communication
hydroxyurea
sickle cell disease
Additional relevant MeSH terms:
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Anemia
Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors