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

The University of Alabama at Birmingham

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Other: Patient-level intervention; Other: Provider-level intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04173026

NIH 5R01HL133896-02

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Provider intervention

Active Comparator group

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.

Treatment:

Other: Provider-level intervention

Provider and Patient level intervention

Active Comparator group

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.

Treatment:

Other: Provider-level intervention

Other: Patient-level intervention