Skip to main content
OpenTrials
Completed

NCT Number: NCT04173026

Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arkansas Children's Research Institute, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Provider-level intervention

Other

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

Other names: Provider Minder

Patient-level intervention

Other

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

Other names: Single Coordinator

Primary outcomes

  1. 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

    Time frame: baseline-2 years

    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.

  2. 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.

    Time frame: baseline-2 years

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

  3. 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

    Time frame: baseline-2 years

    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.

  4. 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.

    Time frame: baseline-2 years

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

Secondary outcomes

  1. Barriers to obtaining TCD screening

    Time frame: baseline-2 years

    Participating sites will carry out key informant interviews with patients/caregivers and stakeholders will be analyzed using content analysis to identify themes pertaining to barriers to obtaining TCD screening, as well as overall perceptions of the intervention(s), barriers to implementing the intervention(s) and satisfaction with the intervention(s).

  2. Enablers to obtaining TCD screening

    Time frame: baseline - 2 years

    Participating sites will carry out key informant interviews with patients/caregivers and stakeholders will be analyzed using content analysis to identify themes pertaining to enablers to obtaining TCD screening, as well as overall perceptions of the intervention(s), enablers to implementing the intervention(s) and satisfaction with the intervention(s).

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3

Acronym: DISPLACE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2019
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.