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

NCT ID: NCT03621826

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5247 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2019-06-28

Brief Summary

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

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.

Conditions

Stroke Ischemic; Sickle Cell Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

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.

Questionnaire/Interview

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Kanter, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

R01HL133896

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00073134

Identifier Type: -

Identifier Source: org_study_id