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

NCT03621826 | Completed

• 2 other identifiers: Pro00073134R01HL133896
• Study Type: observational
• Target: 5,247
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Ischemic; Sickle Cell Disease

Keywords

sickle cell anemia; TCD; screening; dissemination; implementation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Evaluate patient and stakeholder reported barriers to CRCT

  2 years

Study Arms (1)

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

Interventions

Questionnaire/Interview 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.

Children with Sickle Cell Anemia

Eligibility Criteria

• Age: 2 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Anemia, Sickle Cell

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Julie Kanter, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: August 9, 2018
• Study Start: February 12, 2018
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)