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

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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease; Stroke Ischemic
• Intervention / Treatment: Other: Questionnaire/Interview

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5247

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with sickle cell anemia who were between 2-16 years of age from 2012-2016.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with Sickle Cell Anemia; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Julie Kanter, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: screening; implementation; sickle cell anemia; TCD; dissemination
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Stroke; Anemia, Sickle Cell
• Other Study ID Numbers: Pro00073134; R01HL133896 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No