Sickle Cell DiseaseDISPLACENCT04173026
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment
A study testing Provider-level intervention and Patient-level intervention in people with Sickle Cell Disease, run by University of Alabama at Birmingham at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Provider-level intervention and Patient-level intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 15 sitesUnited States
- Study dates
- 4 Jun 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Patients who do not have SCA
- Patients who were born before 2012 and therefore do not meet age criteria.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Children's Heathcare of Atlanta
Atlanta, Georgia, 30322
University of Illinois at Chicago
Chicago, Illinois, 60607
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
University of Florida Health Shands Children's Hospital
Gainesville, Florida, 32608
Vidant Medical Center
Greenville, North Carolina, 27834
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
University of Miami
Miami, Florida, 33136
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232
Columbia University Medical Center
New York, New York, 10032
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Howard University Hospital
Washington D.C., District of Columbia, 20060
Nemours Center for Cancer & Blood Disorders
Wilmington, Delaware, 19803
About this study
Official title: Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3
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.
- Conditions
- Sickle Cell Disease
- Being tested
- Provider-level intervention, Patient-level intervention
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provider-level interventionOther
Also called Provider Minder
Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
Patient-level interventionOther
Also called Single Coordinator
50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen
| Study group | Role | What they receive |
|---|---|---|
| Provider intervention | Active comparator | 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. Receives: Other: Provider-level intervention |
| Provider and Patient level intervention | Active comparator | 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. Receives: Other: Provider-level intervention; Other: Patient-level intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
CRCT has been shown to severely decrease the incidence of stroke in patients who have had TCD screenings with an abnormal result.
Measured: 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
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.
Measured: 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.
Any difference in TCD implementation rates between each intervention arms will help determine optimal implementation procedures.
Measured: baseline-2 years
Secondary outcomes (2)
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).
Measured: baseline-2 years
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).
Measured: baseline - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start4 Jun 2020
- Primary completion1 Feb 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized cluster controlled implementation study
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Kanter, University of Alabama at Birmingham
- Investigators
- Julie Kanter, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173026
- Sponsor's protocol ID
- NIH 5R01HL133896-02
- Acronym
- DISPLACE
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2019
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined.
Publications
Schlenz AM, Phillips SM, Mueller M, Humphrey D, Stevens J, Williams LP, Nickel RS, Dolatshahi L, Miller RE, Hulbert ML, Lee MT, Alvarez O, Fuh B, McNaull MA, Bhasin N, Melvin CL, Adams RJ, Kanter J. Successful implementation of stroke risk screening for sickle cell anemia in the DISPLACE study: results of a cluster randomized trial. Implement Sci. 2025 Nov 26;20(1):50. doi: 10.1186/s13012-025-01462-3.
PubMed 41299691
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) Part 3
- ClinicalTrials.gov ID
- NCT04173026
- Acronym / sponsor ID
- DISPLACE / NIH 5R01HL133896-02
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cluster controlled implementation study
| Arm | Type | Receives |
|---|---|---|
| Provider intervention | Active comparator | Other: Provider-level interventionA 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. |
| Provider and Patient level intervention | Active comparator | Other: Provider-level intervention, Other: Patient-level interventionA 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not have SCA
- Patients who were born before 2012 and therefore do not meet age criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provider-level interventionAlso: Provider MinderProvider minder is a provider-based scheduling and reminder system for stroke screening in SCD | Other | Provider and Patient level intervention, Provider intervention |
| Patient-level interventionAlso: Single Coordinator50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen | Other | Provider and Patient level intervention |
Primary outcome
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
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. 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.
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.
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.
2 secondary outcomes
Barriers to obtaining TCD screening
Time frame: baseline-2 years
Enablers to obtaining TCD screening
Time frame: baseline - 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 41299691Schlenz AM, Phillips SM, Mueller M, Humphrey D, Stevens J, Williams LP, Nickel RS, Dolatshahi L, Miller RE, Hulbert ML, Lee MT, Alvarez O, Fuh B, McNaull MA, Bhasin N, Melvin CL, Adams RJ, Kanter J. Successful implementation of stroke risk screening for sickle cell anemia in the DISPLACE study: results of a cluster randomized trial. Implement Sci. 2025 Nov 26;20(1):50. doi: 10.1186/s13012-025-01462-3.
- Individual participant dataSharing planned: No. To be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Kanter, MD principal investigator
University of Alabama at Birmingham
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provider-level intervention and Patient-level intervention in people with Sickle Cell Disease, run by University of Alabama at Birmingham at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: baseline-2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04173026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.