Clinical trial NCT01836354: Discharge Educational Strategies for Reduction of Vascular Events
Official title: Discharge Educational Strategies for Reduction of Vascular Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Infarcts
Ischemic Stroke
Hemorrhagic Strokes
TIA's
Keywords: stroke
interactive educational intervention
acute ischemic stroke
transient ischemic attack
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2013-04-19
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: 6 months and 1 year
Secondary outcomes:
measure: Secondary Incident
timeFrame: up to 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Bernadette Boden-Albala, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
citation: Goldmann E, Jacoby R, Finfer E, Appleton N, Parikh NS, Roberts ET, Boden-Albala B. Positive Health Beliefs and Blood Pressure Reduction in the DESERVE Study. J Am Heart Assoc. 2020 May 5;9(9):e014782. doi: 10.1161/JAHA.119.014782. Epub 2020 Apr 28.
citation: Boden-Albala B, Goldmann E, Parikh NS, Carman H, Roberts ET, Lord AS, Torrico V, Appleton N, Birkemeier J, Parides M, Quarles L. Efficacy of a Discharge Educational Strategy vs Standard Discharge Care on Reduction of Vascular Risk in Patients With Stroke and Transient Ischemic Attack: The DESERVE Randomized Clinical Trial. JAMA Neurol. 2019 Jan 1;76(1):20-27. doi: 10.1001/jamaneurol.2018.2926.