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REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial) (RESPPECT)

Primary Purpose

Ischemic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced Stroke Education
Usual Stroke Education
Sponsored by
Washington Regional Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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
  • hospice
  • inability to comply with post discharge follow up

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Enhanced Stroke Education

    Usual Stroke Education

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in score of Stroke Knowledge Questionnaire
    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
    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.
    Change in score of Stroke Knowledge Questionnaire
    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 hospital readmission rate
    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.

    Secondary Outcome Measures

    Change in Brief Health Literacy Screen
    2.2.1 We will measure participant perception of health literacy using the Brief Health Literacy Screen. We will administer the Brief Health Literacy Screen during the incident hospital stay and again during the 1 month post discharge appointment. Brief Health Literacy scores range from 4-20 with higher values representing greater participant confidence in health literacy. We will subtract participant baseline score from the 1 month post discharge score. Higher scores reflect improved perception of health literacy.
    Change in systolic blood pressure
    We will measure the last blood pressure (mm Hg) prior to hospital discharge and at the 1 month post discharge appointment. The change in systolic blood pressure will be measured and compared between groups. A greater decline in systolic blood pressure is considered optimal. The number of patients with systolic blood pressure less than 140 mm Hg at hospital discharge and at the 1 month visit will be compared. Systolic blood pressure decline to less than 140 suggests improved control.
    Change in Modified Rankin Score
    We will measure patient mRankin Score (range 0-6) at hospital discharge and at 1 month post discharge appointment. The mRankin Scores will be grouped 0-2, 3-5 and 6. Comparison of a shift to lower or higher group at the 1 month appointment will be made. A shift to lower score group indicates improvement in overall function and independence.
    Change in Barthel Index
    We will measure patient Barthel Index at hospital discharge and at the 1 month post discharge appointment. Barthel Index score ranges 10 - 100 with higher scores indicating greater independence in activities of daily living. Scores will be grouped in quartiles of 10-25, 26- 50, 51-75, 76-100.. Comparison between groups is made with respect change in quartile at the 1 month appointment. A shift to a higher quartile indicates improved independence in activities of daily living.
    Change in Brief Health Literacy Screen
    We will measure participant perception of health literacy using the Brief Health Literacy Screen. We will administer the Brief Health Literacy Screen during the incident hospital stay and again during the 3 month post discharge appointment. Brief Health Literacy scores range from 4-20 with higher values representing greater participant confidence in health literacy. We will subtract participant baseline score from the 3 month post discharge score. Higher scores reflect improved perception of health literacy.
    Change in Modified Rankin Score
    We will measure patient mRankin Score at hospital discharge and at the 6 month post discharge appointment. The mRankin Scores will be grouped 0-2, 3-5 and 6. Comparison of a shift to lower or higher group at the 6 month appointment will be made. A shift to lower score group indicates improvement in overall function and independence.
    Change in Barthel Index
    We will measure patient Barthel Index at hospital discharge and at the 6 month post discharge appointment. Barthel Index score ranges 10 - 100 with higher scores indicating greater independence in activities of daily living. Scores will be grouped in quartiles of 10-25, 26- 50, 51-75, 76-100. Comparison between groups is made with respect change in quartile at the 6 month appointment. A shift to a higher quartile indicates improved independence in activities of daily living.
    Change in systolic blood pressure
    We will measure the last blood pressure (mm Hg) prior to hospital discharge and at the 6 month post discharge appointment. The change in systolic blood pressure will be measured and compared between groups. A greater decline in systolic blood pressure is considered optimal. The number of patients with systolic blood pressure less than 140 mm Hg at hospital discharge and at 6 month visit will also be compared. Systolic blood pressure decline to less than 140 suggests improved control.
    Change in Low Density Lipoprotein cholesterol
    We will measure Low Density Lipoprotein cholesterol (mg/dL) during the incident stroke hospitalization and five to six months post hospitalization. Comparison of change in LDL cholesterol level from baseline value to 5-6 month value will be measured. A larger decline in LDL cholesterol suggests greater diet, physical activity, and / or medication effect.
    Change in Glycated Hemoglobin
    We will measure glycated hemoglobin (%) in all participants during the incident stroke hospitalization and repeat testing in patients with diabetes at five to six months post hospitalization. Comparison of change in glycosylated hemoglobin value in patients with diabetes from baseline value to 5-6 month value will be measured. A larger decline in glycosylated hemoglobin suggests greater diet, physical activity, and / or medication effect.
    Change in Body Mass Index
    We will measure height and weight on all participants and calculate the body mass index in Kg /m2= (weight (Kg) / height (m) x height (m)) during the incident stroke hospitalization and at the six month post hospitalization appointment. Comparison of change in body mass index from baseline value to 6 month value will be measured. A decline in body mass index at 6 months may reflect greater diet, physical activity effect.
    Change in compliance with antithrombotic, cholesterol, antihypertensive, and diabetic medications.
    Participants will be queried about adherence to medication recommendations made prior to incident hospitalization and at 6 month post hospital appointment. Results are scored yes or no for whether patient was compliant in following prescription recommendation for each group of medication: antithrombotic, cholesterol, antihypertensive and glycemic medication. The number of medication groups for which patient is not compliant are totaled for score with a range of 0 to 4. Comparison is made of total non-compliant groups for each patient at hospitalization and at 6 month appointment. Between group comparison is made. Lower values indicate greater medication compliance.

    Full Information

    First Posted
    February 26, 2019
    Last Updated
    February 28, 2019
    Sponsor
    Washington Regional Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03861494
    Brief Title
    REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial)
    Acronym
    RESPPECT
    Official Title
    REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2019 (Anticipated)
    Primary Completion Date
    March 2021 (Anticipated)
    Study Completion Date
    March 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington Regional Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Enhanced Stroke Education
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Usual Stroke Education
    Arm Type
    Other
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    Enhanced Stroke Education
    Intervention Description
    In addition to the general stroke education materials and verbal education, the enhanced stroke education group will receive a personalized verbal and written information addressing the patient's specific risk factors including their current status and goals, laboratory values and goals, and current blood pressure and goal. Specific stroke type and etiology is discussed, medication including indication, dose, frequency, physical activity goals, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, and education over the importance of keeping follow up appointments including Stroke Clinic. Verbal feedback of key points is encouraged.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Stroke Education
    Intervention Description
    The usual stroke education group will receive general stroke education including written and verbal information about signs and symptoms of stroke, best practice to engage medical treatment if stroke occurs, general information about heart healthy diet and need for daily physical activity as well as need for compliance with medication recommendations. The education is incorporated with routine patient care and as allowed during quiet times. On the day of discharge, the patient will receive written materials reviewing stroke symptoms, risk factors, heart healthy diet and follow up appointments. The patient will receive written and verbal information about medications including indication, dose, frequency, physical activity goal, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, the importance of keeping follow up appointments including Stroke Clinic.
    Primary Outcome Measure Information:
    Title
    Change in score of Stroke Knowledge Questionnaire
    Description
    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.
    Time Frame
    30 days
    Title
    Change in hospital readmission rate
    Description
    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.
    Time Frame
    30 days
    Title
    Change in score of Stroke Knowledge Questionnaire
    Description
    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.
    Time Frame
    180 days
    Title
    Change in hospital readmission rate
    Description
    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.
    Time Frame
    180 days
    Secondary Outcome Measure Information:
    Title
    Change in Brief Health Literacy Screen
    Description
    2.2.1 We will measure participant perception of health literacy using the Brief Health Literacy Screen. We will administer the Brief Health Literacy Screen during the incident hospital stay and again during the 1 month post discharge appointment. Brief Health Literacy scores range from 4-20 with higher values representing greater participant confidence in health literacy. We will subtract participant baseline score from the 1 month post discharge score. Higher scores reflect improved perception of health literacy.
    Time Frame
    30 days
    Title
    Change in systolic blood pressure
    Description
    We will measure the last blood pressure (mm Hg) prior to hospital discharge and at the 1 month post discharge appointment. The change in systolic blood pressure will be measured and compared between groups. A greater decline in systolic blood pressure is considered optimal. The number of patients with systolic blood pressure less than 140 mm Hg at hospital discharge and at the 1 month visit will be compared. Systolic blood pressure decline to less than 140 suggests improved control.
    Time Frame
    30 days
    Title
    Change in Modified Rankin Score
    Description
    We will measure patient mRankin Score (range 0-6) at hospital discharge and at 1 month post discharge appointment. The mRankin Scores will be grouped 0-2, 3-5 and 6. Comparison of a shift to lower or higher group at the 1 month appointment will be made. A shift to lower score group indicates improvement in overall function and independence.
    Time Frame
    30 days
    Title
    Change in Barthel Index
    Description
    We will measure patient Barthel Index at hospital discharge and at the 1 month post discharge appointment. Barthel Index score ranges 10 - 100 with higher scores indicating greater independence in activities of daily living. Scores will be grouped in quartiles of 10-25, 26- 50, 51-75, 76-100.. Comparison between groups is made with respect change in quartile at the 1 month appointment. A shift to a higher quartile indicates improved independence in activities of daily living.
    Time Frame
    30 days
    Title
    Change in Brief Health Literacy Screen
    Description
    We will measure participant perception of health literacy using the Brief Health Literacy Screen. We will administer the Brief Health Literacy Screen during the incident hospital stay and again during the 3 month post discharge appointment. Brief Health Literacy scores range from 4-20 with higher values representing greater participant confidence in health literacy. We will subtract participant baseline score from the 3 month post discharge score. Higher scores reflect improved perception of health literacy.
    Time Frame
    180 days
    Title
    Change in Modified Rankin Score
    Description
    We will measure patient mRankin Score at hospital discharge and at the 6 month post discharge appointment. The mRankin Scores will be grouped 0-2, 3-5 and 6. Comparison of a shift to lower or higher group at the 6 month appointment will be made. A shift to lower score group indicates improvement in overall function and independence.
    Time Frame
    180 days
    Title
    Change in Barthel Index
    Description
    We will measure patient Barthel Index at hospital discharge and at the 6 month post discharge appointment. Barthel Index score ranges 10 - 100 with higher scores indicating greater independence in activities of daily living. Scores will be grouped in quartiles of 10-25, 26- 50, 51-75, 76-100. Comparison between groups is made with respect change in quartile at the 6 month appointment. A shift to a higher quartile indicates improved independence in activities of daily living.
    Time Frame
    180 days
    Title
    Change in systolic blood pressure
    Description
    We will measure the last blood pressure (mm Hg) prior to hospital discharge and at the 6 month post discharge appointment. The change in systolic blood pressure will be measured and compared between groups. A greater decline in systolic blood pressure is considered optimal. The number of patients with systolic blood pressure less than 140 mm Hg at hospital discharge and at 6 month visit will also be compared. Systolic blood pressure decline to less than 140 suggests improved control.
    Time Frame
    180 days
    Title
    Change in Low Density Lipoprotein cholesterol
    Description
    We will measure Low Density Lipoprotein cholesterol (mg/dL) during the incident stroke hospitalization and five to six months post hospitalization. Comparison of change in LDL cholesterol level from baseline value to 5-6 month value will be measured. A larger decline in LDL cholesterol suggests greater diet, physical activity, and / or medication effect.
    Time Frame
    150 -180 days
    Title
    Change in Glycated Hemoglobin
    Description
    We will measure glycated hemoglobin (%) in all participants during the incident stroke hospitalization and repeat testing in patients with diabetes at five to six months post hospitalization. Comparison of change in glycosylated hemoglobin value in patients with diabetes from baseline value to 5-6 month value will be measured. A larger decline in glycosylated hemoglobin suggests greater diet, physical activity, and / or medication effect.
    Time Frame
    150-180 days
    Title
    Change in Body Mass Index
    Description
    We will measure height and weight on all participants and calculate the body mass index in Kg /m2= (weight (Kg) / height (m) x height (m)) during the incident stroke hospitalization and at the six month post hospitalization appointment. Comparison of change in body mass index from baseline value to 6 month value will be measured. A decline in body mass index at 6 months may reflect greater diet, physical activity effect.
    Time Frame
    180 days
    Title
    Change in compliance with antithrombotic, cholesterol, antihypertensive, and diabetic medications.
    Description
    Participants will be queried about adherence to medication recommendations made prior to incident hospitalization and at 6 month post hospital appointment. Results are scored yes or no for whether patient was compliant in following prescription recommendation for each group of medication: antithrombotic, cholesterol, antihypertensive and glycemic medication. The number of medication groups for which patient is not compliant are totaled for score with a range of 0 to 4. Comparison is made of total non-compliant groups for each patient at hospitalization and at 6 month appointment. Between group comparison is made. Lower values indicate greater medication compliance.
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 hospice inability to comply with post discharge follow up
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kasha Pinkerton, BSN
    Phone
    479-463-3382
    Email
    kpinkerton@wregional.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Felicia May, APRN
    Phone
    479-404-1250
    Email
    fmay@wregional.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Margaret Tremwel, MD
    Organizational Affiliation
    Washington Regional Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    REcurrent Stroke Prevention Through Personalized Education by Clinical Trainers (RESPPECT Trial)

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