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

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ClinicalTrials.gov Identifier: NCT04173026
Recruitment Status : Not yet recruiting
First Posted : November 21, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Kanter, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Provider-level intervention Other: Patient-level intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized cluster controlled implementation study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


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.
Other: Provider-level intervention
Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Other Name: Provider Minder

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.
Other: Provider-level intervention
Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Other Name: Provider Minder

Other: Patient-level intervention
50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen
Other Name: Single Coordinator




Primary Outcome Measures :
  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 SCD (Sickle Cell Disease) 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 Outcome Measures :
  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).



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173026


Contacts
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Contact: Sarah L Moderhack, BS 205-975-6215 smoderhack@uabmc.edu
Contact: Emily Warner, BA 205-996-1735 ewarner@uabmc.edu

Locations
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United States, Arkansas
Arkansas Children's Research Institute
Little Rock, Arkansas, United States, 72202
Contact: Suzanne Saccente       saccentesuzannec@uams.edu   
Contact: Carol Pierce       PierceCarolD@uams.edu   
United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Contact: Lynn Neumayr       LNeumayr@mail.cho.org   
Contact: Mariam Hammed       mhameed@mail.cho.org   
United States, Delaware
Nemours Center for Cancer & Blood Disorders
Wilmington, Delaware, United States, 19803
Contact: Miller Robin       rmiller@nemours.org   
Contact: Jean Wadman       jean.wadman@nemours.org   
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Contact: Nickel Robert       rnickel@childrensnational.org   
Contact: Elaine Passley       epassley@childrensnational.org   
Howard University Hospital
Washington, District of Columbia, United States, 20060
Contact: Sohail Rana       srana@howard.edu   
Contact: Patricia Houston       phouston@howard.edu   
United States, Florida
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
Contact: Hector Rodriguez-Cortes       hrodriguez-cort@browardhealth.org   
Contact: Noella Dietz       ndietz@browardhealth.org   
University of Florida Health Shands Children's Hospital
Gainesville, Florida, United States, 32608
Contact: Vandy Black       vblack@ufl.edu   
Contact: Shannon Burcham       bsunstar@ufl.edu   
University of Miami
Miami, Florida, United States, 33136
Contact: Ofelia Alvarez       oalvarez2@med.miami.edu   
Contact: Sandra Echenique       s.echenique@miami.edu   
United States, Georgia
Children's Heathcare of Atlanta
Atlanta, Georgia, United States, 30322
Contact: Clark Brown       clark.brown@choa.org   
Contact: Megan McNeil       megan.mcneil@choa.org   
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
Contact: Lewis Hsu       lewhsu@uic.edu   
Contact: Jocelyn Mallard       jmalla1@uic.edu   
United States, Missouri
SSM Health Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Contact: Leili Dolatshahi       dolatshahilj@slu.edu   
Contact: Abigail Sharamitaro       abigail.sharamitaro@ssmhealth.com   
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Contact: Monica Hulbert       hulbert_m@kids.wustl.edu   
Contact: Kusal Mihindukulasurya       klmihind@wustl.edu   
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Contact: Lee Margaret       ml653@cumc.columbia.edu   
Contact: Fiona Sanders       fs2107@cumc.columbia.edu   
United States, North Carolina
Vidant Medical Center
Greenville, North Carolina, United States, 27834
Contact: Beng Fuh       fuhb@ecu.edu   
Contact: Lindsay Cortright       cortrightl16@ecu.edu   
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232
Contact: Emmanuel Volanakis       emmanuel.volanakis@vanderbilt.edu   
Contact: Brock Hodges       brock.hodges@vumc.org   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Julie Kanter, MD University of Alabama at Birmingham

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Responsible Party: Julie Kanter, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04173026    
Other Study ID Numbers: NIH 5R01HL133896-02
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn