Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

NCT04173026 | Completed

• 1 other identifier: NIH 5R01HL133896-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 15

Brief Summary

The Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) study is a multi-center, national, National Heart, Lung and Blood Institute (NHLBI)-funded grant to look at the real-world implementation of stroke prevention guidelines (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). Part 3 of the DISPLACE study is an implementation clinical trial designed to test novel implementation strategies with the goal of improving adherence and implementation of stroke screening. 16 of the lowest scoring implementation rates from DISPLACE Part 1 will participate in DISPLACE Part 3. All original 28 sites from DISPLACE Parts 1 and 2 will receive a patient and provider educational intervention including a re-branding of the TCD as "Sickle Stroke Screen" with a new infographic and educational materials. The 16 sites with moving to Part 3 will be provided a Provider reminder strategy, which is a web based application designed to remind providers of when patients are due for their Sickle Stroke Screen. These 16 sites will be randomized and 8 will be given an additional Patient Communication Strategy. These sites will have a single designed coordinator with whom patients will communicate with about scheduling, rescheduling, and any other questions regarding their Sickle Stroke Screen. Upon completion, data will be analyzed to compare those who have had TCD screenings done appropriately and those who did not as well as the overall effect of the multi level interventions on the changes in TCD rates.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (4)

• 1. Change in uptake and use of the stroke prevention guidelines (STOP Protocol) as defined in the NHLBI (National Heart, Lung, and Blood Institute) 2014 Sickle Cell Disease (SCD) Guidelines by assessing stroke risk with yearly TCD screens

  The TCD measures the speed of blood flow in the blood vessels of the brain. Any unusually slow of fast speed may indicate a child is at a higher risk for stroke. By ensuring patients receive a yearly TCD more children will get a proper intervention and ideally prevent stroke.

  baseline-2 years

• 2. Change in uptake and use of the stroke prevention guidelines (STOP Protocol) as defined in the NHLBI 2014 SCD Guidelines by implementing chronic red cell transfusion (CRCT) in patients noted to have abnormal TCD screens.

  CRCT has been shown to severely decrease the incidence of stroke in patients who have had TCD screenings with an abnormal result.

  baseline-2 years

• Change in uptake and use of the stroke prevention guidelines (STOP Protocol) as defined in the NHLBI (National Heart, Lung, and Blood Institute) 2014 SCD (Sickle Cell Disease) Guidelines by re-screening patients with conditional TCD screens

  Patients who have a condition TCD are considered to of slightly higher risk than patients with a normal TCD. By re-screening these patients in a shorter time period, providers are able to confirm or reject the initial screening and make the best plan for stroke prevention depending on these outcomes.

  baseline-2 years

• A difference in uptake and use of the stroke prevention guidelines (STOP Protocol) as defined in the NHLBI 2014 SCD Guidelines between between implementation arms measured by assessing yearly TCD screening rates.

  Any difference in TCD implementation rates between each intervention arms will help determine optimal implementation procedures.

  baseline-2 years

Secondary Outcomes (2)

• Barriers to obtaining TCD screening

  baseline-2 years

• Enablers to obtaining TCD screening

  baseline - 2 years

Study Arms (2)

Provider intervention

ACTIVE COMPARATOR

A web-based application called ProviderMinder has been developed and will be used to alert providers when a patient who has been lost-to-follow-up or has missed their Sickle Stroke Screen (TCD). This will allow providers to follow up with such patients and improve screening rates.

Other: Provider-level intervention

Provider and Patient level intervention

ACTIVE COMPARATOR

A web-based application called ProviderMinder has been developed and will be used to alert providers when a patient who has been lost-to-follow-up or has missed their Sickle Stroke Screen (TCD). This will allow providers to follow up with such patients and improve screening rates. Additionally, sites will have a patient intervention of a single Sickle Stroke Screen coordinator who will interact directly with patients to schedule, reschedule, remind, and follow-up on stroke screening. This person will also act as a point of contact for any educational needs the patient may have. The second patient intervention will include the caregivers own mobile device. When Sickle Stroke Screens are scheduled the coordinator will ensure these appointments are directly put into the caregiver's mobile device calendar acting as an additional reminder for stroke screening.

Other: Provider-level intervention; Other: Patient-level intervention

Interventions

Provider-level intervention OTHER

Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD

Also known as: Provider Minder

Provider and Patient level intervention; Provider intervention

Patient-level intervention OTHER

50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen

Also known as: Single Coordinator

Provider and Patient level intervention

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with sickle cell anemia (SCA) identified at each institution through International Classification of Diseases 9/10 (ICD-9/ICD-10) codes and local patient databases.
• Patients must have been seen by the designated institution (documented in medical record) a minimum of two times in the either inpatient or outpatient setting at the institution between the years of 01/01/2018-12/31/2019.
• Patients identified will include those currently aged 2-7. Thus children born from 2012 and onward.
• Patients already receiving primary or secondary stroke prevention therapy with CRCT will be included in registration in Web Data Coordination Unit (WEBDCU) but not included in PROVIDER MINDER as they do not require ongoing TCD/SICKLE STROKE SCREEN based on protocol.

You may not qualify if:

• Patients who do not have SCA
• Patients who were born before 2012 and therefore do not meet age criteria.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (15)

Arkansas Children's Research Institute

Little Rock, Arkansas, 72202, United States

Location

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609, United States

Location

Nemours Center for Cancer & Blood Disorders

Wilmington, Delaware, 19803, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

University of Florida Health Shands Children's Hospital

Gainesville, Florida, 32608, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Children's Heathcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Schlenz AM, Phillips SM, Mueller M, Humphrey D, Stevens J, Williams LP, Nickel RS, Dolatshahi L, Miller RE, Hulbert ML, Lee MT, Alvarez O, Fuh B, McNaull MA, Bhasin N, Melvin CL, Adams RJ, Kanter J. Successful implementation of stroke risk screening for sickle cell anemia in the DISPLACE study: results of a cluster randomized trial. Implement Sci. 2025 Nov 26;20(1):50. doi: 10.1186/s13012-025-01462-3.

  PMID: 41299691 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Julie Kanter, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized cluster controlled implementation study

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: June 4, 2020
• Primary Completion: February 1, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)