Clinical trial NCT03452813: Transitions of Care Stroke Disparity Study (TCSD-S)
Official title: Transitions of Care Stroke Disparity Study (TCSD-S)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: transitions of care
stroke disparities
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-03-02
Enrollment: 1549
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Transitions of Stroke Care Performance Index
timeFrame: 30 days
measure: Hospital readmission
timeFrame: 90 days
Secondary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 90 days
measure: Stroke recurrence
timeFrame: 90 days
measure: Cardiovascular events
timeFrame: 90 days
measure: Mortality rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: UNIVERISTY OF MIAMI
name: Jose G Romano, MD
role: PRINCIPAL_INVESTIGATOR
References: