Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

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

Patrocinadores

Patrocinador principal: University of Alabama at Birmingham

Fuente University of Alabama at Birmingham
Resumen breve

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.

Estado general Active, not recruiting
Fecha de inicio June 4, 2020
Fecha de Terminación June 1, 2022
Fecha de finalización primaria December 1, 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
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 baseline-2 years
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. baseline-2 years
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 baseline-2 years
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. baseline-2 years
Resultado secundario
Medida Periodo de tiempo
Barriers to obtaining TCD screening baseline-2 years
Enablers to obtaining TCD screening baseline - 2 years
Inscripción 16
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Provider-level intervention

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

Otro nombre: Provider Minder

Tipo de intervención: Other

Nombre de intervención: Patient-level intervention

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

Etiqueta de grupo de brazo: Provider and Patient level intervention

Otro nombre: Single Coordinator

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 2 Years

Edad máxima: 7 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Apellido Papel Afiliación
Julie Kanter, MD Principal Investigator University of Alabama at Birmingham
Ubicación
Instalaciones:
Arkansas Children's Research Institute | Little Rock, Arkansas, 72202, United States
UCSF Benioff Children's Hospital Oakland | Oakland, California, 94609, United States
Nemours Center for Cancer & Blood Disorders | Wilmington, Delaware, 19803, United States
Children's National Medical Center | Washington, District of Columbia, 20010, United States
Howard University Hospital | Washington, District of Columbia, 20060, United States
Broward Health Medical Center | Fort Lauderdale, Florida, 33316, United States
University of Florida Health Shands Children's Hospital | Gainesville, Florida, 32608, United States
University of Miami | Miami, Florida, 33136, United States
Children's Heathcare of Atlanta | Atlanta, Georgia, 30322, United States
University of Illinois at Chicago | Chicago, Illinois, 60607, United States
SSM Health Cardinal Glennon Children's Hospital | Saint Louis, Missouri, 63104, United States
St. Louis Children's Hospital | Saint Louis, Missouri, 63110, United States
Columbia University Medical Center | New York, New York, 10032, United States
Vidant Medical Center | Greenville, North Carolina, 27834, United States
Vanderbilt Children's Hospital | Nashville, Tennessee, 37232, United States
Ubicacion Paises

United States

Fecha de verificación

June 2020

Fiesta responsable

Tipo: Principal Investigator

Afiliación del investigador: University of Alabama at Birmingham

Nombre completo del investigador: Julie Kanter

Título del investigador: Principal Investigator

Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Provider intervention

Tipo: Active Comparator

Descripción: 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.

Etiqueta: Provider and Patient level intervention

Tipo: Active Comparator

Descripción: 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.

Acrónimo DISPLACE
Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Randomized cluster controlled implementation study

Propósito primario: Other

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov