Discharge Educational Strategies for Reduction of Vascular Events

Ischemic Stroke Clinical Trial

— DESERVE  

Official title:

Discharge Educational Strategies for Reduction of Vascular Events

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836354
• Other study ID #: 14-00718
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: November 2019

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: November 2019
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Strokes
• Intracerebral Infarcts
• Ischemic Stroke
• Stroke
• TIA's

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Columbia University	New York	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	Columbia University, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure	change in overall blood pressure	6 months and 1 year
Secondary	Secondary Incident	A secondary outcome is when the patient has a new visit to the ED or another hospital; admission that it is not a stroke/TIA nor ICH. Instead, it might be a seizure, headache, migraine, anything else neurological.	up to 3 years