Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

Sickle Cell Disease Clinical Trial

— DISPLACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173026
• Other study ID #: NIH 5R01HL133896-02
• Status: Completed
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Provider-level intervention
Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
• Patient-level intervention
50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen

Locations

Country	Name	City	State
United States	Children's Heathcare of Atlanta	Atlanta	Georgia
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	University of Florida Health Shands Children's Hospital	Gainesville	Florida
United States	Vidant Medical Center	Greenville	North Carolina
United States	Arkansas Children's Research Institute	Little Rock	Arkansas
United States	University of Miami	Miami	Florida
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	SSM Health Cardinal Glennon Children's Hospital	Saint Louis	Missouri
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Children's National Medical Center	Washington	District of Columbia
United States	Howard University Hospital	Washington	District of Columbia
United States	Nemours Center for Cancer & Blood Disorders	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Barriers to obtaining TCD screening	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).	baseline-2 years
Secondary	Enablers to obtaining TCD screening	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).	baseline - 2 years