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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider-level intervention
Patient-level intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sickle Cell Disease

Eligibility Criteria

2 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arkansas Children's Research Institute
  • UCSF Benioff Children's Hospital Oakland
  • Nemours Center for Cancer & Blood Disorders
  • Children's National Medical Center
  • Howard University Hospital
  • Broward Health Medical Center
  • University of Florida Health Shands Children's Hospital
  • University of Miami
  • Children's Heathcare of Atlanta
  • University of Illinois at Chicago
  • SSM Health Cardinal Glennon Children's Hospital
  • St. Louis Children's Hospital
  • Columbia University Medical Center
  • Vidant Medical Center
  • Vanderbilt Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Provider intervention

Provider and Patient level intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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).
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).

Full Information

First Posted
November 15, 2019
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04173026
Brief Title
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment
Acronym
DISPLACE
Official Title
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized cluster controlled implementation study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Provider and Patient level intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Provider-level intervention
Other Intervention Name(s)
Provider Minder
Intervention Description
Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Intervention Type
Other
Intervention Name(s)
Patient-level intervention
Other Intervention Name(s)
Single Coordinator
Intervention Description
50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
baseline-2 years
Title
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.
Description
CRCT has been shown to severely decrease the incidence of stroke in patients who have had TCD screenings with an abnormal result.
Time Frame
baseline-2 years
Title
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
Description
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.
Time Frame
baseline-2 years
Title
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.
Description
Any difference in TCD implementation rates between each intervention arms will help determine optimal implementation procedures.
Time Frame
baseline-2 years
Secondary Outcome Measure Information:
Title
Barriers to obtaining TCD screening
Description
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).
Time Frame
baseline-2 years
Title
Enablers to obtaining TCD screening
Description
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).
Time Frame
baseline - 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Kanter, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Children's Research Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Nemours Center for Cancer & Blood Disorders
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Broward Health Medical Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida Health Shands Children's Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Children's Heathcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
SSM Health Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined.

Learn more about this trial

Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

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