Stroke IschemicDISPLACENCT03621826
Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease
An observational study of Stroke Ischemic and Sickle Cell Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. Read more about this study
- Who is it for?
- Ages 2 to 24 years
- Conditions the study is for
- Stroke Ischemic, Sickle Cell Disease
- What is being tested?
- Questionnaire/Interview
- How many people
- 5,247 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 28 Jun 2019
- Phase
- Observational
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with sickle cell anemia who were between 2-16 years of age from 2012-2016.
Who may be able to join
- Age is >2 and <16 at time of review (from 2012-2016)
- have documented sickle cell anemia
- primary language is English
- patient at a DISPLACE consortium institution
- Caregiver Characteristics:
- Parent or guardian of patient who meets above criteria Primary language is English Has the cognitive capacity to complete questionnaires
Who cannot join
- Child Characteristics:
- Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever)
- Caregiver Characteristics:
- Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: DISPLACE: Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (Part 1 and 2)
DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. However, many children are not getting the screening they need. This study will examine the issues that hinder and help children get the screening at 28 different hospitals and sickle cell centers to improve care for all children with sickle cell anemia. The investigators will then plan a study (part 3) aimed to improve stroke screening and prevention in sickle cell anemia.
Read the detailed description
DISPLACE (Dissemination and Implementation of Stroke Prevention: Looking At the Care Environment) is a multi-center, national NHLBI-funded grant to evaluate the real world implementation of the 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). Based on the STOP (Stroke Prevention Trial in Sickle Cell Anemia) protocol, children identified as high risk of stroke by TCD are initiated on chronic red cell transfusion therapy (CRCT) for stroke prevention. Children with normal TCD are screened annually from the age of 2 until they are 16 years of age.
This will be a THREE-part study beginning with Part 1 - a retrospective case record review followed by Part 2 - a multi-level qualitative assessment of barriers and enablers to TCD screening and initiation of chronic red blood cell transfusions and later adding Part 3 - a multi-center implementation clinical trial.The investigators will compare two implementation interventions to improve TCD screening.
There are three aims of the grant and each aim is equivalent to the respective parts of the grant (i.e. Part 1 covers 1 aim). There are a total 28 consortium sites. The Medical University of South Carolina is the lead institution for this study.
- Conditions
- Stroke Ischemic, Sickle Cell Disease
- Being tested
- Questionnaire/Interview
- Keywords
- sickle cell anemia, TCD, screening, dissemination, implementation
- Medical subject headings
- Ischemic Stroke, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire/InterviewOther
A convenience sample of patients/parents and stakeholders will be asked to participate in a survey and/or interview to evaluate barriers to care in sickle cell.
| Study group | Role | What they receive |
|---|---|---|
| Children with Sickle Cell Anemia | Data from patients with sickle cell anemia will be entered into a retrospective database for evaluation of implementation rates of TCD (stroke) screening). A small number of these children/parents/stakeholders will be selected by convenience sampling to participate in a survey and/or interview to assess barriers and enablers to stroke prevention therapy. Receives: Other: Questionnaire/Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual TCD screening rates (retrospective data assessment)
Current rate of TCD screening over the last 5 years
Measured: 2 years
Identify the barriers and enablers to TCD screening
This study will assess two different implementation strategies to improve TCD screening. To determine which strategy is more effective, a difference in TCD screening rates of at least 17% between intervention arms is necessary. If there is not at least a 17% difference in annual TCD screening rates, it will be impossible to determine the optimal implementation procedures
Measured: 2 years
Retrospective assessment of initiation of chronic transfusion therapy in patients over the last 5 years in those children at risk of stroke
Patients with abnormal TCD should be started on chronic transfusion therapy. The goal of the intervention is to increase institutional initiation of CRCT in at least 95% of patients noted to have abnormal TCD
Measured: 2 years
Secondary outcomes (1)
Evaluate patient and stakeholder reported barriers to CRCT
The investigators will asses barriers to CRCT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Feb 2018
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke IschemicStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 5,247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Julie Kanter, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621826
- Sponsor's protocol ID
- Pro00073134
- Other IDs
- R01HL133896
- Acronym
- DISPLACE
- Status last verified
- Jul 2019
- First submitted
- 29 Mar 2018
- Last updated
- 11 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DISPLACE: Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (Part 1 and 2)
- ClinicalTrials.gov ID
- NCT03621826
- Acronym / sponsor ID
- DISPLACE / Pro00073134
- Conditions
- Stroke Ischemic, Sickle Cell Disease
- Keywords
- sickle cell anemia, TCD, screening, dissemination, implementation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,247 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 9 Aug 2018 (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.
DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. However, many children are not getting the screening they need. This study will examine the issues that hinder and help children get the screening at 28 different hospitals and sickle cell centers to improve care for all children with sickle cell anemia. The investigators will then plan a study (part 3) aimed to improve stroke screening and prevention in sickle cell anemia.
Detailed description
DISPLACE (Dissemination and Implementation of Stroke Prevention: Looking At the Care Environment) is a multi-center, national NHLBI-funded grant to evaluate the real world implementation of the 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). Based on the STOP (Stroke Prevention Trial in Sickle Cell Anemia) protocol, children identified as high risk of stroke by TCD are initiated on chronic red cell transfusion therapy (CRCT) for stroke prevention. Children with normal TCD are screened annually from the age of 2 until they are 16 years of age.
This will be a THREE-part study beginning with Part 1 - a retrospective case record review followed by Part 2 - a multi-level qualitative assessment of barriers and enablers to TCD screening and initiation of chronic red blood cell transfusions and later adding Part 3 - a multi-center implementation clinical trial.The investigators will compare two implementation interventions to improve TCD screening.
There are three aims of the grant and each aim is equivalent to the respective parts of the grant (i.e. Part 1 covers 1 aim). There are a total 28 consortium sites. The Medical University of South Carolina is the lead institution for this study.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Sickle Cell Anemia | – | Other: Questionnaire/InterviewData from patients with sickle cell anemia will be entered into a retrospective database for evaluation of implementation rates of TCD (stroke) screening). A small number of these children/parents/stakeholders will be selected by convenience sampling to participate in a survey and/or interview to assess barriers and enablers to stroke prevention therapy. |
Who may qualify
- Ages
- 2 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with sickle cell anemia who were between 2-16 years of age from 2012-2016.
Key inclusion criteria (6 listed)
- Age is >2 and <16 at time of review (from 2012-2016)
- have documented sickle cell anemia
- primary language is English
- patient at a DISPLACE consortium institution
- Parent or guardian of patient who meets above criteria Primary language is English Has the cognitive capacity to complete questionnaires
Key exclusion criteria (4 listed)
- Experiencing current acute complications of sickle cell disease requiring hospitalization or an acute care visit (e.g., pain crises, acute chest syndrome, acute cerebrovascular events/stroke or active infection/fever)
- Has a child experiencing current acute complication of sickle cell disease, such as pain crisis, acute chest syndrome, stroke, or infection.
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 |
|---|---|---|
| Questionnaire/InterviewA convenience sample of patients/parents and stakeholders will be asked to participate in a survey and/or interview to evaluate barriers to care in sickle cell. | Other | Children with Sickle Cell Anemia |
Primary outcome
Annual TCD screening rates (retrospective data assessment)
Time frame: 2 years
Current rate of TCD screening over the last 5 years
Identify the barriers and enablers to TCD screening
Time frame: 2 years
This study will assess two different implementation strategies to improve TCD screening. To determine which strategy is more effective, a difference in TCD screening rates of at least 17% between intervention arms is necessary. If there is not at least a 17% difference in annual TCD screening rates, it will be impossible to determine the optimal implementation procedures
Retrospective assessment of initiation of chronic transfusion therapy in patients over the last 5 years in those children at risk of stroke
Time frame: 2 years
Patients with abnormal TCD should be started on chronic transfusion therapy. The goal of the intervention is to increase institutional initiation of CRCT in at least 95% of patients noted to have abnormal TCD
1 secondary outcome
Evaluate patient and stakeholder reported barriers to CRCT
Time frame: 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 11 Jul 2019.
- Individual participant dataSharing planned: No
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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
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Ischemic and Sickle Cell Disease, run by Medical University of South Carolina at 1 site 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 6 inclusion and 4 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 11 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Annual TCD screening rates (retrospective data assessment) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2019.