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Study ID 1012
Name Dissemination and Implementation of Stroke Prevention Looking at the Care Environment
Contact Email jkanter@uabmc.edu
Acronym DISPLACE
Period ongoing
Design Clinical trial
Study PI Julie Kanter
Institution University of Alabama at Birmingham
URL https://clinicaltrials.gov/ct2/show/NCT04173026
CTGovID https://clinicaltrials.gov/ct2/show/NCT04173026
Funding Agency NHLBI
Grant Number 5R01HL133896-02
Overview 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).
Focus Areas 1. Barriers to obtaining TCD screening [ Time Frame: baseline-2 years ]
2. Enablers to obtaining TCD screening [ Time Frame: baseline - 2 years ]
Outcomes 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 ]
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 ]
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 ]
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 ]
Data Location UAB
Biospecimen Available Blood; DNA;
Data Consent All of the local data collected are specific to the present project. All data will be marked with an anonymous identifier created automatically for each patient. Only the local PIs and research coordinators will have access to patient names.
Biospecimen Consent waiver
Contact Consent NA
Genomic Data No
Age Range 2-7
No. Participants 5247
Inclusion Criteria 1. 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.
2. 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.
3. Patients identified will include those currently aged 2-7. Thus children born from 2012 and onward.
4. 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 1. Patients who do not have SCA
2. Patients who were born before 2012 and therefore do not meet age criteria.
Study Documentation
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   1. DISPLACE IRB Protocol_Part 1 FINAL 10.20.17
   2. DISPLACE part 3 Protocol Version final
Forms
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CRFs July2019

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