Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sickle Cell Anemia
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Enrollment
- 176
- Locations
- 11
- Primary Endpoint
- Decisional Conflict
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis: sickle cell disease
- •Age: birth-5 years, inclusive
- •Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical complications)
- •Child's parent, legal guardian, or designated decision maker (caregiver) must participate in both study visits
- •Child's parent, legal guardian, or designated decision maker (caregiver) must able to read, understand, and speak English
Exclusion Criteria
- •Parent/legal guardian has previously been approached OR made a decision about whether to initiate hydroxyurea.
- •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.
Outcomes
Primary Outcomes
Decisional Conflict
Time Frame: Baseline - after shared discussion with clinician
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) that are summed, divided by the number of items (3 or4) and multiplied by 25. Scores range from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice) on the total score and all subscores. Thus, a higher score indicates a high decisional conflict.
Dyadic OPTION
Time Frame: Baseline visit - after shared discussion with clinician
Dyadic OPTION describes clinician behaviors to involve a patient/parent in decision-making. A total score is calculated which ranges from 0 (no involvement) to 100 (maximal involvement). Dyadic OPTION scores correlate well with OPTION scale (Melbourne et al., 2011); 1 item "My doctor and I made the decision together"(Légaré et al., 2010). Higher scores indicate that the patient/parent has higher shared decision making competencies.
Secondary Outcomes
- Hydroxyurea Offered(From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 months)
- Satisfaction With Decision-Making(Baseline after the shared discussion)
- Ages & Stages Questionnaire - Gross Motor Subscale(After discussion with clinician)
- Pediatric Quality of Life Inventory - Sickle Cell Disease Module (Peds QL - SCD Module) - Total Score(After shared discussion with clinician)
- Hydroxyurea Knowledge(After shared discussion with clinician)