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Study Detail

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

Data ElementVariables
Acute Anemic Episode
Aplastic Crisis
Bleeding
Other Blood Problem
Sickle Cell Disease 501v1Q01
501v1Q02
501v1Q03
SCD_DIAG
SCD_TYPE
Data ElementVariables
Aneurysm
Cardiac Failure
Cardiovascular Problem
Heart Problem 503v1Q05
503v1Q06
503v1Q07
Data ElementVariables
Gastrointestinal Problem 503v1Q08
503v1Q09
503v1Q10
503v1Q11
Hepatitis
Liver Problem
Data ElementVariables
Fever
HIV Infection
Immune Problem
Infection 503v1Q15
503v1Q16
503v1Q17
503v1Q18
503v1Q19
Vaccination
Data ElementVariables
Sarcoidosis
Spleen Problem 503v1Q12
503v1Q13
503v1Q14
Data ElementVariables
Adverse event
Death 126v3Q03
126v3Q06
126v3Q10
Disability Status
Hospitalization
Medical Event
Serious Adverse Event
Data ElementVariables
Behavior
Cognition 502v1Q04
502v1Q05
502v1Q06
Developmental 502v1Q01
502v1Q02
502v1Q03
502v1Q03-specify
Motor
Sensation
Data ElementVariables
Meningitis
Neurologic Event 503v1Q01
503v1Q01-A
503v1Q01-B
503v1Q02-A
503v1Q02-B
503v1Q03-A
503v1Q03-B
503v1Q04-A
503v1Q04-B
Seizure
Stroke
Transient Ischemic Attack
Data ElementVariables
Acute Chest Syndrome
Asthma 503v1Q03
503v1Q04
Lung Disease
Other Respiratory Problem
Data ElementVariables
Address
Age 101v1Q01
Enrollment_Q06
Ethnic Group Enrollment_Q04
Gender Enrollment_Q03
Language
National Origin
Nuclear Family
Race Enrollment_Q05
Data ElementVariables
Annual Income
Education
Employment Status
Household
Insurance 510v1Q02
Marital Status
Data ElementVariables
Facility Type 126v3Q13
126v3Q14
Provider Type
Quality of Care
Visit
Data ElementVariables
Abdomen
Bone
Brain 506v3Q06-specify
506v3Q07
506v3Q6
Chest
Data ElementVariables
Echocardiogram 509v2Q01
509v2Q02
509v2Q03
509v2Q04
509v2Qa
Data ElementVariables
General Imaging 506v3Q01
506v3Q02
506v3Qa
Data ElementVariables
Brain 506v3Q03
506v3Q03-specify
506v3Q04
506v3Q04-specify
506v3Q05
Heart
Hip
Liver
Data ElementVariables
Brain 504v3Q01
504v3Q02
504v3Q03
504v3Q04
504v3Q05
504v3Q06
504v3Q07
504v3Q08
504v3Q09
504v3Q09-specify
504v3Q10
504v3Q11
504v3Q12
504v3Q13
504v3Q14
504v3Q15
504v3Q16
504v3Q16-specify
504v3Q17
504v3Q18
504v3Q19
504v3Q20
Data ElementVariables
Psychosocial
Relationship 510v1Q03
510v1Q03-specify
Data ElementVariables
Blood Differential Test 151v2Q08
151v2Q09
151v2Q10
Blood Gases
Blood Smear
Blood Typing
Coagulation Test
Complete Blood Count 151v2Q02
151v2Q03
151v2Q04
151v2Q05
151v2Q06
151v2Q07
Comprehensive Metabolic Panel (CMP)
Enzyme
General
Hemoglobin Electrophoresis
Iron 151v2Q11
Data ElementVariables
Abdomen
Anthropometrics
Cardiovascular
Extremities
General
Liver
Reproductive
Respiratory
Spleen
Vital signs 117v1Qa
118v1Qb
119v1Q01
120v1Q02
121v1Q03
122v1Q04
123v1Q05
124v1Q06
Data ElementVariables
Antibiotics
Asthma
Blood Medication History
Cardiovascular
Compliance
Current Medication 114v2Q01
114v2Q02-1A
114v2Q02-1B
114v2Q02-1C
114v2Q02-1D
114v2Q02-1E
114v2Q02-1F
114v2Q02-1G
114v2Q02-1H
114v2Q02-1J
114v2Q02-1L
114v2Q02-2A
114v2Q02-2B
114v2Q02-2C
114v2Q02-2D
114v2Q02-2E
114v2Q02-2F
114v2Q02-2G
114v2Q02-2H
114v2Q02-2J
114v2Q02-2L
114v2Q02-3A
114v2Q02-3B
114v2Q02-3C
114v2Q02-3D
114v2Q02-3E
114v2Q02-3F
114v2Q02-3G
114v2Q02-3H
114v2Q02-3J
114v2Q02-3L
114v2Q02-4A
114v2Q02-4B
114v2Q02-4C
114v2Q02-4D
114v2Q02-4E
114v2Q02-4F
114v2Q02-4G
114v2Q02-4H
114v2Q02-4J
114v2Q02-4L
Depression Medication History
Hydroxyurea 511v1Q01
511v1Q02-1A
511v1Q02-1B
511v1Q02-1C
511v1Q02-1D
511v1Q02-1E
511v1Q02-1F
511v1Q02-1G
511v1Q02-1H
511v1Q02-2A
511v1Q02-2B
511v1Q02-2C
511v1Q02-2D
511v1Q02-2E
511v1Q02-2F
511v1Q02-2G
511v1Q02-2H
511v1Q02-3A
511v1Q02-3B
511v1Q02-3C
511v1Q02-3D
511v1Q02-3E
511v1Q02-3F
511v1Q02-3G
511v1Q02-3H
Medication
Neurologic Medication History
Pain
SCD Medication
Sildenafil
Supplements
Data ElementVariables
Blood Transfusion
Chronic Transfusion 505v1Q01
505v1Q02
505v1Q02-specify
505v1Q03
505v1Q04
505v1Q05
505v1Q06
Transfusion Complications
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