Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease

Study Overview
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Brief Summary
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DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. However, many children are not getting the screening they need. This study will examine the issues that hinder and help children get the screening at 28 different hospitals and sickle cell centers to improve care for all children with sickle cell anemia. The investigators will then plan a study (part 3) aimed to improve stroke screening and prevention in sickle cell anemia.

Detailed Description
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DISPLACE (Dissemination and Implementation of Stroke Prevention: Looking At the Care Environment) is a multi-center, national NHLBI-funded grant to evaluate the real world implementation of the STOP protocol in which transcranial Doppler (TCD), a measure of cerebral blood vessel velocity, is used to screen for stroke risk in children ages 2-16 with sickle cell anemia (SCA). Based on the STOP (Stroke Prevention Trial in Sickle Cell Anemia) protocol, children identified as high risk of stroke by TCD are initiated on chronic red cell transfusion therapy (CRCT) for stroke prevention. Children with normal TCD are screened annually from the age of 2 until they are 16 years of age. This will be a THREE-part study beginning with Part 1 - a retrospective case record review followed by Part 2 - a multi-level qualitative assessment of barriers and enablers to TCD screening and initiation of chronic red blood cell transfusions and later adding Part 3 - a multi-center implementation clinical trial.The investigators will compare two implementation interventions to improve TCD screening. There are three aims of the grant and each aim is equivalent to the respective parts of the grant (i.e. Part 1 covers 1 aim). There are a total 28 consortium sites. The Medical University of South Carolina is the lead institution for this study.

Official Title
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DISPLACE: Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (Part 1 and 2)

Conditions
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Stroke Ischemic, Sickle Cell Disease

Intervention / Treatment
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* Other: Questionnaire/Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is >2 and <16 at time of review (from 2012-2016) have documented sickle cell anemia primary language is English patient at a DISPLACE consortium institution Caregiver Characteristics: Parent or guardian of patient who meets above criteria Primary language is English Has the cognitive capacity to complete questionnaires EXCLUSION CRITERIA: Child Characteristics: Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever) Caregiver Characteristics: Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with Sickle Cell Anemia<br>Data from patients with sickle cell anemia will be entered into a retrospective database for evaluation of implementation rates of TCD (stroke) screening). A small number of these children/parents/stakeholders will be selected by convenience sampling to participate in a survey and/or interview to assess barriers and enablers to stroke prevention therapy. | Other: Questionnaire/Interview<br>* A convenience sample of patients/parents and stakeholders will be asked to participate in a survey and/or interview to evaluate barriers to care in sickle cell.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual TCD screening rates (retrospective data assessment) | Current rate of TCD screening over the last 5 years | 2 years | 
| Identify the barriers and enablers to TCD screening | This study will assess two different implementation strategies to improve TCD screening. To determine which strategy is more effective, a difference in TCD screening rates of at least 17% between intervention arms is necessary. If there is not at least a 17% difference in annual TCD screening rates, it will be impossible to determine the optimal implementation procedures | 2 years | 
| Retrospective assessment of initiation of chronic transfusion therapy in patients over the last 5 years in those children at risk of stroke | Patients with abnormal TCD should be started on chronic transfusion therapy. The goal of the intervention is to increase institutional initiation of CRCT in at least 95% of patients noted to have abnormal TCD | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate patient and stakeholder reported barriers to CRCT | The investigators will asses barriers to CRCT | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell anemia, TCD, screening, dissemination, implementation