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Transitions of Care Stroke Disparity Study (TCSD-S) (TCSD-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452813
Recruitment Status : Recruiting
First Posted : March 2, 2018
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami

Brief 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 discharge to home in 2,400 participants across 6 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.

Condition or disease
Stroke

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 in 2,400 participants across 6 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Transitions of Care Stroke Disparity Study (TCSD-S)
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022



Primary Outcome Measures :
  1. 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.

  2. Hospital readmission [ Time Frame: 90 days ]
    Review and documentation of the participants readmission to hospital within 90 days post discharge


Secondary Outcome Measures :
  1. Modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Measurement of participants degree of disability/dependence in daily activities. The scale runs from 0 (No symptoms at all) to 6 (dead).

  2. Stroke recurrence [ Time Frame: 90 days ]
    documentation of the number of times a participant has experienced another stroke.

  3. Cardiovascular events [ Time Frame: 90 days ]
    incident cardiovascular events

  4. Mortality rate [ Time Frame: 90 days ]
    number of deaths



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Ischemic stroke or intracerebral hemorrhage patients age >/=18 years that are discharged directly to home.

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.

Exclusion Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452813


Contacts
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Contact: Carolina Gutierrez, PhD 305-243-7850 cgutierrez2@med.miami.edu

Locations
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United States, Florida
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Digna Cabral    305-243-8018    dcabral@med.miami.edu   
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Carolina Gutierrez, PhD    305-243-7850    cgutierrez2@med.miami.edu   
Sponsors and Collaborators
University of Miami
National Institute on Minority Health and Health Disparities (NIMHD)
Additional Information:

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Responsible Party: Jose Romano, MD, Principal Investigator, University of Miami
ClinicalTrials.gov Identifier: NCT03452813    
Other Study ID Numbers: 20170892
1R01MD012467 ( U.S. NIH Grant/Contract )
20170892 ( Other Identifier: IRB )
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Romano, MD, University of Miami:
transitions of care
stroke disparities
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases