Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

NCT ID: NCT04173026

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-04

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized cluster controlled implementation study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Provider-level intervention

Intervention Type OTHER

Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD

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.

Group Type ACTIVE_COMPARATOR

Provider-level intervention

Intervention Type OTHER

Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD

Patient-level intervention

Intervention Type OTHER

50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen

Interventions

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Provider-level intervention

Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD

Intervention Type OTHER

Patient-level intervention

50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen

Intervention Type OTHER

Other Intervention Names

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Provider Minder Single Coordinator

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Julie Kanter

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Kanter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Arkansas Children's Research Institute

Little Rock, Arkansas, United States

Site Status

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Site Status

Nemours Center for Cancer & Blood Disorders

Wilmington, Delaware, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Howard University Hospital

Washington D.C., District of Columbia, United States

Site Status

Broward Health Medical Center

Fort Lauderdale, Florida, United States

Site Status

University of Florida Health Shands Children's Hospital

Gainesville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Children's Heathcare of Atlanta

Atlanta, Georgia, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Vidant Medical Center

Greenville, North Carolina, United States

Site Status

Vanderbilt Children's Hospital

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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NIH 5R01HL133896-02

Identifier Type: -

Identifier Source: org_study_id

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