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Clinical Trials/NCT03861494
NCT03861494CompletedNot Applicable

REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers

Washington Regional Medical Center1 site in 1 country21 target enrollmentStarted: May 6, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
21
Locations
1
Primary Endpoint
Change in hospital readmission rate

Study Overview

Brief Summary

This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education.

Detailed Description

This a single blind randomized control study comparing standard of care for nursing hospital discharge education versus same with an additional experimental enhanced educational intervention. It is planned that 300 patients will be enrolled in the study. There are two initial groups: the enhanced stroke education vs usual stroke education. Patients who meet inclusion and not exclusion criteria and provide signed informed consent will be randomized to one of the two groups. Assignments will be made based on the order of entry into the stroke study database where every other patient entered will be assigned to the treatment group. If the patient's caregiver is the primary person responsible for administration of medication, determination of meals and activity, the caregiver may be enrolled instead of or in addition to the patient. This will be determined by preference of the patient and caregiver after discussion of their usual practice. A Neuroscience trained Registered Nurse is a nurse who has received specialized education from the organization regarding care of patients with stroke and other neurologic illnesses. The Neuroscience trained Registered Nurse will provide all patients with basic stroke and risk factor information, educational materials and follow-up. The usual care group of patients will receive education provided by the Neuroscience trained Registered Nurse who provides care for the patient daily. Education will be provided on an ongoing basis throughout the hospital stay with additional focused education provided at the time of discharge (within 24 hours of hospital discharge). The education will include written and verbal information. Educational content focuses on a variety of topics of stroke prevention, detection and management. The enhanced stroke education group will receive the same usual care for patient education given by the Neuroscience trained Registered Nurse. The enhanced stroke education patient will receive a one -time enhanced specific goal-directed educational experience given by a specifically trained Stroke Coordinator on the day of discharge. The enhanced education is tailored to the unique risk factors of the patient and key concepts for stroke prevention, detection and management The patient will be given goals specific to their personal risk factors. Emphasis on specific goals for lifestyle change are emphasized. Verbal feedback of key concepts is encouraged.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Care Provider)

Masking Description

The who Advanced Practice Registered Nurse performing the outpatient follow up visits at one and six months will remain blinded to the enrollment of each participant.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •patients hospitalized with primary diagnosis of acute or subacute ischemic cerebral infarction
  • •18 years of age or older
  • •English speaking
  • •admitted to hospital Sunday through Thursday
  • •patient or responsible primary caregiver able to understand and provide informed consent
  • •prognosis for survival greater than 6 months
  • •one or more vascular risk factors (HTN, DLP, current smoker, DM, obesity)
  • •live in NWA area (Benton, Boone, Carroll, Madison, and Washington counties),
  • •have a working phone.

Exclusion Criteria

  • •admitted with transient ischemic attack
  • •admitted with an intracerebral hemorrhage
  • •experience an in-hospital ischemic cerebral infarction
  • •hospital to hospital transfer patients
  • •nursing home as primary residence before or after discharge
  • •inability to comply with post discharge follow up

Arms & Interventions

Enhanced Stroke Education

Other

This group of participants will receive enhanced education provided by the Stroke Coordinator at the time of discharge. The enhanced education session will last 30 minutes with the participant.

Intervention: Enhanced Stroke Education (Behavioral)

Usual Stroke Education

Other

This group of participants will receive the usual stroke education provided by the usual Neuroscience Registered Nurse throughout the hospitalization and at the time of discharge.

Intervention: Usual Stroke Education (Behavioral)

Outcomes

Primary Outcomes

Change in hospital readmission rate

Time Frame: 180 days

We will measure the readmission rate at 180 days and compare readmission rates between the two groups of usual education and enhanced education. Lower readmission rates is considered optimal.

Change in score of Stroke Knowledge Questionnaire

Time Frame: 180 days

2.1.1 We will measure participant retention of in-hospital stroke education using a Stroke Knowledge Questionnaire. The questionnaire consists of 17 items. Scores range from 1-17. The questionnaire is based on the American Heart Association Stroke Knowledge Questionnaire. The questionnaire is administered during the incident hospitalization for stroke (baseline score) and repeated at the 6 month post discharge appointment. The baseline score is subtracted from the 6 month appointment score and the result reflects improvement or worsening performance. The two groups are compared with respect to this difference between baseline pre-stroke education score (number correct) and 6 month post discharge score. Greater positive difference between pre-test and 6 month test reflect improved performance.

Change in score of Stroke Knowledge Questionnaire

Time Frame: 30 days

2.1.1 We will measure participant retention of in-hospital stroke education using a Stroke Knowledge Questionnaire. The questionnaire consists of 17 items. Scores range from 1-17. The questionnaire is based on the American Heart Association Stroke Knowledge Questionnaire. The questionnaire is administered during incident hospitalization for stroke (baseline score) and repeated at the 1 month post discharge appointment. The baseline score is subtracted from the 1 month appointment score and the result reflects improvement or worsening performance. The two groups are compared with respect to this difference between baseline pre-stroke education score (number correct) and 1 month post discharge score. Greater positive difference between pre-test and 1 month test reflect improved performance.

Change in hospital readmission rate

Time Frame: 30 days

2.1.2 We will measure the hospital readmission rate at 30 days and compare readmission rates between the two groups of usual education and enhanced education. Lower readmission rates is considered optimal.

Secondary Outcomes

  • Change in Body Mass Index(180 days)
  • Change in Glycated Hemoglobin(150-180 days)
  • Change in systolic blood pressure(180 days)
  • Change in compliance with antithrombotic, cholesterol, antihypertensive, and diabetic medications.(180 days)
  • Change in Brief Health Literacy Screen(180 days)
  • Change in Modified Rankin Score(180 days)
  • Change in Barthel Index(180 days)
  • Change in Low Density Lipoprotein cholesterol(150 -180 days)
  • Change in Brief Health Literacy Screen(30 days)
  • Change in systolic blood pressure(30 days)
  • Change in Modified Rankin Score(30 days)
  • Change in Barthel Index(30 days)

Investigators

Sponsor
Washington Regional Medical Center
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Margaret Tremwel

Stroke Program Medical Director

Washington Regional Medical Center

Study Sites (1)

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