- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04173026
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE)
June 29, 2023 updated by: Julie Kanter, University of Alabama at Birmingham
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Research Institute
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California
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Oakland, California, United States, 94609
- UCSF Benioff Children's Hospital Oakland
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Delaware
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Wilmington, Delaware, United States, 19803
- Nemours Center for Cancer & Blood Disorders
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Washington, District of Columbia, United States, 20060
- Howard University Hospital
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Florida
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Fort Lauderdale, Florida, United States, 33316
- Broward Health Medical Center
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Gainesville, Florida, United States, 32608
- University of Florida Health Shands Children's Hospital
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Heathcare of Atlanta
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Illinois
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Chicago, Illinois, United States, 60607
- University of Illinois at Chicago
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Missouri
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Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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Saint Louis, Missouri, United States, 63104
- SSM Health Cardinal Glennon Children's Hospital
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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North Carolina
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Greenville, North Carolina, United States, 27834
- Vidant Medical Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 7 years (Child)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Provider intervention
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.
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Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Other Names:
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Active Comparator: Provider and Patient level intervention
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.
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Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Other Names:
50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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baseline-2 years
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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
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CRCT has been shown to severely decrease the incidence of stroke in patients who have had TCD screenings with an abnormal result.
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baseline-2 years
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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.
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baseline-2 years
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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
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Any difference in TCD implementation rates between each intervention arms will help determine optimal implementation procedures.
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baseline-2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barriers to obtaining TCD screening
Time Frame: baseline-2 years
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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).
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baseline-2 years
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Enablers to obtaining TCD screening
Time Frame: baseline - 2 years
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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).
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baseline - 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Julie Kanter, MD, University of Alabama at Birmingham
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2020
Primary Completion (Actual)
February 1, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
November 15, 2019
First Submitted That Met QC Criteria
November 19, 2019
First Posted (Actual)
November 21, 2019
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 29, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIH 5R01HL133896-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To be determined.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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