Transitions of Care Stroke Disparity Study (TCSD-S)

NCT03452813 | Completed

• 2 other identifiers: 201708921R01MD012467
• Study Type: observational
• Target: 1,549
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Stroke

Keywords

transitions of care; stroke disparities

Outcome Measures

Primary Outcomes (2)

• 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.

  30 days

• Hospital readmission

  Review and documentation of the participants readmission to hospital within 90 days post discharge

  90 days

Secondary Outcomes (4)

• Modified Rankin Scale (mRS)

  90 days

• Stroke recurrence

  90 days

• Cardiovascular events

  90 days

• Mortality rate

  90 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Miami: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (2)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Dong 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.

  PMID: 36533520 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose G Romano, MD

  UNIVERISTY OF MIAMI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 2, 2018
• Study Start: June 1, 2018
• Primary Completion: June 30, 2023
• Study Completion: December 11, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)