Discharge Educational Strategies for Reduction of Vascular Events

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

552 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2019-11-30

Brief Summary

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DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects diagnosed with TIA, or mild stroke to either risk factor education or usual care. Those patients assigned to education will receive stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk.

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Detailed Description

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Stroke and its risk factors disproportionately affect minority populations, and secondary stroke prevention programs have had relatively little success. TIA and mild stroke patients with few after-affects also stay in the hospital for a shorter period of time, and leave without enough information about their risk for another stroke. Additionally, mild stroke and TIA patients often do not follow-up with neurologists after they leave the hospital. DESERVE is a discharge education study using health workers to enroll and randomly assign 800 subjects from MSSM, MSSM Queens and CUMC diagnosed with Transient Ischemic attack (TIA ), mild Ischemic stroke (IS) or mild Intracerebral Hemorrhage (ICH) to either risk factor education or usual care. Those patients assigned to education will receive education on stroke preparedness education plus risk factor reduction education, and help accessing follow up care with health workers. This education includes a power point presentation and a patient-paced workbook and video on Risk perception, Medication Adherence, and Patient-Physician Communication. To target the most appropriate mild IS/ICH and TIA survivors for participation in this proposal, we will focus on survivors with mild stroke and TIA, excluding those whose stroke deficits are severe enough to warrant discharge to a nursing home or to require 24-hour care.

Those patients assigned to usual care will receive written stroke preparedness education. This protocol will evaluate the effectiveness of this intervention to reduce blood pressure, and individual stroke risk factors and future stroke risk. Additionally, we will evaluate the ability of the these strategies to conduct education to affect positive change in taking medications as directed, stroke knowledge 6 months and 12 months after hospital admission, attendance at follow-up health care appointments, and cost-effectiveness. After 1 year participants will be followed quarterly for up to 3 years to track events.

Conditions

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Intracerebral Infarcts Ischemic Stroke Hemorrhagic Strokes TIA's

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DESERVE education

Intervention group will receive education on stroke preparedness plus risk factor reduction education, and help accessing follow up care with health workers.

Group Type ACTIVE_COMPARATOR

DESERVE education

Intervention Type BEHAVIORAL

Those patients assigned to education will receive stroke comprehensive intervention which focuses on three main areas, Risk perception, Medication Adherence, and Patient-Physician Communication. We will test whether phone calls and visits with a health worker after discharge, videos and a workbook are linked to better control of blood pressure and other risk factors

Usual Care

The usual care group will only receive written preparedness education, which is the standard care for the hospital.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DESERVE education

Those patients assigned to education will receive stroke comprehensive intervention which focuses on three main areas, Risk perception, Medication Adherence, and Patient-Physician Communication. We will test whether phone calls and visits with a health worker after discharge, videos and a workbook are linked to better control of blood pressure and other risk factors

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with mild ischemic cerebral infarction or mild intracerebral hemorrhage (NIHSS \< 5) or TIA based on a clinical definition of focal neurologic deficits consistent with a single vascular territory of the brain
* Aged greater than 18 years at onset of event
* Resident of NY Metropolitan community in home with land or cell phone.
* Vascular risk factors including HTN history or elevated blood pressure (\>130/85 mmHg) at the time of discharge, smoking, diabetes or metabolic syndrome
* Discharge to home
* English or Spanish Speaker

Exclusion Criteria

* Patients unable to give informed consent
* Discharged to long-term nursing home or requiring 24 hour care.
* A Modified Rankin score \> 2 at baseline
* Pre-stroke dementia history.
* Patients with end stage cancer, or other medical conditions resulting in mortality less than 1 year.
* Patient does not speak English or Spanish.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No