Transitions of Care Stroke Disparity Study (TCSD-S)

Completed

• Conditions: Stroke

• Registration Number: NCT03452813
• Lead Sponsor: 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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-02-26
• Study First Posted: 2018-03-02
• Study Start: 2018-06-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1549

Inclusion Criteria

• 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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital readmission	90 days	Review and documentation of the participants readmission to hospital within 90 days post discharge
Transitions of Stroke Care Performance Index	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.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular events	90 days	incident cardiovascular events
Mortality rate	90 days	number of deaths
Modified Rankin Scale (mRS)	90 days	Measurement of participants degree of disability/dependence in daily activities. The scale runs from 0 (No symptoms at all) to 6 (dead).
Stroke recurrence	90 days	documentation of the number of times a participant has experienced another stroke.

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Miami, Florida, United States

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States