StrokeTCSD-SNCT03452813
Transitions of Care Stroke Disparity Study (TCSD-S)
An observational study of Stroke, run by University of Miami at 2 sites in United States.
Trial summary
The TCSD Study will identify disparities in transitions of stroke care and key factors associated with effective transitions of care through structured telephone interviews to evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions and medical follow-up 30 days after hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 1,549 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 11 Dec 2023
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The TCSD-S participating study sites (SS) include 6 Comprehensive Stroke Centers (CSC) that currently participate in the Florida Stroke Registry will be Study. The SS will identify and consent participants and collect TOSC performance metrics and outcomes. A total of 2,400 ischemic stroke and intracerebral hemorrhage participants from 6 Florida CSC that are discharged directly to home will be enrolled in this study.
Who may be able to join
- Ischemic stroke or intracerebral hemorrhage patients age >/=18 years that are discharged directly to home, or discharged to rehab
- Final diagnosis of ischemic stroke or intracerebral hemorrhage, included in the Get With
- The Guidelines- Stroke (GWTG-S) database.
- Patient or legally authorized representative provides consent
- Available by phone and willing to receive two follow-up calls.
Who cannot join
- Cases with subarachnoid hemorrhage, transient ischemic attack (TIA), stroke not otherwise specified, no stroke related diagnosis, and admission for elective carotid intervention will be excluded.
- Prisoners will be excluded. The purpose of the project is to study the hospital-to-home transition of stroke care.
- Discharged to inpatient rehabilitation, nursing home, subacute rehabilitation facilities or assisted living facilities. These facilities support medication adherence, provide prescribed diets, often provide in-house medical follow-up, and therefore disparities in TOSC are less likely to be detected and not amenable to the proposed interventions.
- Modified Rankin Scale of 0 after stroke. These individuals usually do not require any rehabilitation interventions and to avid the inclusion of predominately mild stroke patients.
- Unable to obtain consent from patient or legally authorized representative.
- Unavailable or unwilling to participate in the 30 and 90 day follow up telephone calls.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
About this study
The TCSD Study will identify disparities in transitions of stroke care and key factors associated with effective transitions of care through structured telephone interviews to evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions and medical follow-up 30 days after hospital discharge to home in 2,400 participants across 12 comprehensive stroke centers (CSC) in Florida. A novel Transitions of Stroke Care Performance Index (TOSC PI) correlated with 90-day rehospitalization will be derived and validated.
Read the detailed description
The TCSD Study will identify disparities in transitions of stroke care and key factors associated with effective transitions of care through structured telephone interviews to evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions and medical follow-up 30 days after hospital discharge to home and in-patient care rehabilitation in 2,400 participants across 12 comprehensive stroke centers (CSC) in Florida. A novel Transitions of Stroke Care Performance Index (TOSC PI) will be derived and validated. The primary outcomes are the TOSC PI and 90-day readmission. Other stroke outcomes include stroke disability, recurrence, cardiovascular events, and death at 3 months. Outcomes will be collected through telephone interviews and review of patient charts. Predictors of disparities in transition of care and outcomes will be evaluated using baseline in-hospital data during acute stroke hospitalization obtained from the Florida Stroke Registry and Social Determinants of Health obtained through novel data collected from publicly available records. Based on identified predictors of disparities in TOSC, we will develop and demonstrate feasibility of initiatives for interventions to reduce disparities in TOSC that target systems of care with a TOSC disparities dashboard, and health care providers with a training module for enhanced education and support at discharge and during follow-up. We will evaluate any temporal improvements in the TOSC Performance Index and outcomes before and after the interventions.
- Conditions
- Stroke
- Keywords
- transitions of care, stroke disparities
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ischemic stroke or intracerebral hemorrhage patients | patients discharged from hospital to home or discharged to rehab will be called at 30 day and 90 day to monitor their transition of care outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transitions of Stroke Care Performance Index
Transitions of Stroke Care Performance Index (TOSC-PI) is a novel score that will be developed based on the results of this study to predict effective transitions of care, and will be composite score that includes medication and lifestyle adherence, diet, tobacco and alcohol cessation, exercise, utilization of rehabilitation services, and medical follow-up after discharge. The index will be calculated as the points achieved over the total for which the participant is eligible. High scores indicate successful transition of care, while low scores reflect inadequacies and gaps in transitions of care.
Measured: 30 days
Hospital readmission
Review and documentation of the participants readmission to hospital within 90 days post discharge
Measured: 90 days
Secondary outcomes (4)
Modified Rankin Scale (mRS)
Measurement of participants degree of disability/dependence in daily activities. The scale runs from 0 (No symptoms at all) to 6 (dead).
Measured: 90 days
Stroke recurrence
documentation of the number of times a participant has experienced another stroke.
Measured: 90 days
Cardiovascular events
incident cardiovascular events
Measured: 90 days
Mortality rate
number of deaths
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,549 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jose Romano, MD, University of Miami
- Investigators
- Jose G Romano, MD, Principal investigator, UNIVERISTY OF MIAMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452813
- Sponsor's protocol ID
- 20170892
- Other IDs
- 1R01MD012467, 20170892
- Acronym
- TCSD-S
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2018
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veledar E, Zhou L, Veledar O, Gardener H, Gutierrez CM, Brown SC, Fakoori F, Johnson KH, Del Brutto VJ, Alkhachroum A, Rose DZ, Perue GG, Asdaghi N, Romano JG, Rundek T. Identifying determinants of readmission and death post-stroke using explainable machine learning. PLoS One. 2025 Sep 18;20(9):e0332371. doi: 10.1371/journal.pone.0332371. eCollection 2025.
PubMed 40966264Dong C, Gardener H, Rundek T, Marulanda E, Gutierrez CM, Campo-Bustillo I, Gordon Perue G, Johnson KH, Sacco RL, Romano JG; Transitions of Care Stroke Disparities Study (TCSD-S) Investigatorsdagger. Factors and Behaviors Related to Successful Transition of Care After Hospitalization for Ischemic Stroke. Stroke. 2023 Feb;54(2):468-475. doi: 10.1161/STROKEAHA.122.040891. Epub 2022 Dec 19.
PubMed 36533520
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitions of Care Stroke Disparity Study (TCSD-S)
- ClinicalTrials.gov ID
- NCT03452813
- Acronym / sponsor ID
- TCSD-S / 20170892
- Conditions
- Stroke
- Keywords
- transitions of care, stroke disparities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,549 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 2 Mar 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.
The TCSD Study will identify disparities in transitions of stroke care and key factors associated with effective transitions of care through structured telephone interviews to evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions and medical follow-up 30 days after hospital discharge to home in 2,400 participants across 12 comprehensive stroke centers (CSC) in Florida. A novel Transitions of Stroke Care Performance Index (TOSC PI) correlated with 90-day rehospitalization will be derived and validated.
Detailed description
The TCSD Study will identify disparities in transitions of stroke care and key factors associated with effective transitions of care through structured telephone interviews to evaluate medication adherence, healthy lifestyle, utilization of rehabilitation interventions and medical follow-up 30 days after hospital discharge to home and in-patient care rehabilitation in 2,400 participants across 12 comprehensive stroke centers (CSC) in Florida. A novel Transitions of Stroke Care Performance Index (TOSC PI) will be derived and validated. The primary outcomes are the TOSC PI and 90-day readmission. Other stroke outcomes include stroke disability, recurrence, cardiovascular events, and death at 3 months. Outcomes will be collected through telephone interviews and review of patient charts. Predictors of disparities in transition of care and outcomes will be evaluated using baseline in-hospital data during acute stroke hospitalization obtained from the Florida Stroke Registry and Social Determinants of Health obtained through novel data collected from publicly available records. Based on identified predictors of disparities in TOSC, we will develop and demonstrate feasibility of initiatives for interventions to reduce disparities in TOSC that target systems of care with a TOSC disparities dashboard, and health care providers with a training module for enhanced education and support at discharge and during follow-up. We will evaluate any temporal improvements in the TOSC Performance Index and outcomes before and after the interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ischemic stroke or intracerebral hemorrhage patients | – | –patients discharged from hospital to home or discharged to rehab will be called at 30 day and 90 day to monitor their transition of care outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The TCSD-S participating study sites (SS) include 6 Comprehensive Stroke Centers (CSC) that currently participate in the Florida Stroke Registry will be Study. The SS will identify and consent participants and collect TOSC performance metrics and outcomes. A total of 2,400 ischemic stroke and intracerebral hemorrhage participants from 6 Florida CSC that are discharged directly to home will be enrolled in this study.
Key inclusion criteria (5 listed)
- Ischemic stroke or intracerebral hemorrhage patients age >/=18 years that are discharged directly to home, or discharged to rehab
- Final diagnosis of ischemic stroke or intracerebral hemorrhage, included in the Get With
- The Guidelines- Stroke (GWTG-S) database.
- Patient or legally authorized representative provides consent
- Available by phone and willing to receive two follow-up calls.
Key exclusion criteria (6 listed)
- Cases with subarachnoid hemorrhage, transient ischemic attack (TIA), stroke not otherwise specified, no stroke related diagnosis, and admission for elective carotid intervention will be excluded.
- Prisoners will be excluded. The purpose of the project is to study the hospital-to-home transition of stroke care.
- Discharged to inpatient rehabilitation, nursing home, subacute rehabilitation facilities or assisted living facilities. These facilities support medication adherence, provide prescribed diets, often provide in-house medical follow-up, and therefore disparities in TOSC are less likely to be detected and not amenable to the proposed interventions.
- Modified Rankin Scale of 0 after stroke. These individuals usually do not require any rehabilitation interventions and to avid the inclusion of predominately mild stroke patients.
- Unable to obtain consent from patient or legally authorized representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transitions of Stroke Care Performance Index
Time frame: 30 days
Transitions of Stroke Care Performance Index (TOSC-PI) is a novel score that will be developed based on the results of this study to predict effective transitions of care, and will be composite score that includes medication and lifestyle adherence, diet, tobacco and alcohol cessation, exercise, utilization of rehabilitation services, and medical follow-up after discharge. The index will be calculated as the points achieved over the total for which the participant is eligible. High scores indicate successful transition of care, while low scores reflect inadequacies and gaps in transitions of care.
Hospital readmission
Time frame: 90 days
Review and documentation of the participants readmission to hospital within 90 days post discharge
4 secondary outcomes
Modified Rankin Scale (mRS)
Time frame: 90 days
Stroke recurrence
Time frame: 90 days
Cardiovascular events
Time frame: 90 days
Mortality rate
Time frame: 90 days
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 16 Apr 2024.
- Derived from this study: PubMed 40966264Veledar E, Zhou L, Veledar O, Gardener H, Gutierrez CM, Brown SC, Fakoori F, Johnson KH, Del Brutto VJ, Alkhachroum A, Rose DZ, Perue GG, Asdaghi N, Romano JG, Rundek T. Identifying determinants of readmission and death post-stroke using explainable machine learning. PLoS One. 2025 Sep 18;20(9):e0332371. doi: 10.1371/journal.pone.0332371. eCollection 2025.
- Derived from this study: PubMed 36533520Dong C, Gardener H, Rundek T, Marulanda E, Gutierrez CM, Campo-Bustillo I, Gordon Perue G, Johnson KH, Sacco RL, Romano JG; Transitions of Care Stroke Disparities Study (TCSD-S) Investigatorsdagger. Factors and Behaviors Related to Successful Transition of Care After Hospitalization for Ischemic Stroke. Stroke. 2023 Feb;54(2):468-475. doi: 10.1161/STROKEAHA.122.040891. Epub 2022 Dec 19.
- 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.
Jose G Romano, MD principal investigator
UNIVERISTY OF MIAMI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Miami at 2 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 5 inclusion and 6 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Transitions of Stroke Care Performance Index (time frame: 30 days). The study lists 2 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 NCT03452813, which also lists 2 linked publications.
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 16 Apr 2024.