Back to resultsImproving Coordination and Transitions of Care in Stroke Patients
Primary Purpose
Stroke, Transient Ischemic Attack
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nursing care model
Sponsored by
About this trial
This is an interventional health services research trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- > 18 years of age
- Admission to the Hospital of the University of Pennsylvania Vascular Neurology service
- Incident or recurrent:
- Ischemic stroke: focal neurological deficit of likely ischemic vascular origin
- Intracerebral hemorrhage: blood seen on initial head CT
- Transient Ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved
Exclusion Criteria:
- Pregnancy
- Comfort or hospice care
- Severe dementia prior to stroke
- Non-communicative and have no family/social support
Sites / Locations
- Hospital of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Attending nurse model
Conventional inpatient nursing care
Arm Description
The attending nurse model of in-hospital care delivery aims to improve patient understanding, shared decision making, medication adherence, and reduce early readmissions after discharge to improve quality of life. On the inpatient stroke unit, the attending nurse will take ownership of essential aspects of an individual stroke patient's care, education, and transition out of the hospital. To further contribute to the patient's plan of care, the attending nurse will be present on daily teaching rounds.
Standard of care nursing care patients receive while inpatient
Outcomes
Primary Outcome Measures
Stroke Patient Education Retention tool
measures patient knowledge about stroke
MMAS-4: Four question Morizky Scale
medication adherence measurement
Secondary Outcome Measures
Questionnaire to capture patient impression of their in-hospital care, transition home and quality of life
Stroke Impact Scale
Proportion of readmissions
Full Information
NCT ID
NCT02642744
First Posted
December 24, 2015
Last Updated
January 19, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02642744
Brief Title
Improving Coordination and Transitions of Care in Stroke Patients
Official Title
Improving Coordination and Transitions of Care for Stroke Patients With an Attending Nurse: a Comparative Effectiveness Single Center Study Comparing Models of Nursing Care
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine if the attending nurse model will enhance critical patient-centered elements of care that will in turn improve patient education and shared decision-making, medication adherence, stroke-related health literacy, and reduce early readmissions to ultimately yield improved patient quality of life. Our primary objective is to determine whether the attending nurse model of care improves stroke patients' health at 7 days, 30 days, and 90 days after hospital discharge as assessed through questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Transient Ischemic Attack
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attending nurse model
Arm Type
Other
Arm Description
The attending nurse model of in-hospital care delivery aims to improve patient understanding, shared decision making, medication adherence, and reduce early readmissions after discharge to improve quality of life. On the inpatient stroke unit, the attending nurse will take ownership of essential aspects of an individual stroke patient's care, education, and transition out of the hospital. To further contribute to the patient's plan of care, the attending nurse will be present on daily teaching rounds.
Arm Title
Conventional inpatient nursing care
Arm Type
No Intervention
Arm Description
Standard of care nursing care patients receive while inpatient
Intervention Type
Other
Intervention Name(s)
Nursing care model
Intervention Description
Subjects will be randomized into either the attending nursing model of care vs the standard nursing model
Primary Outcome Measure Information:
Title
Stroke Patient Education Retention tool
Description
measures patient knowledge about stroke
Time Frame
90 days
Title
MMAS-4: Four question Morizky Scale
Description
medication adherence measurement
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
Questionnaire to capture patient impression of their in-hospital care, transition home and quality of life
Time Frame
90 days
Title
Stroke Impact Scale
Time Frame
30 days
Title
Proportion of readmissions
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 18 years of age
Admission to the Hospital of the University of Pennsylvania Vascular Neurology service
Incident or recurrent:
Ischemic stroke: focal neurological deficit of likely ischemic vascular origin
Intracerebral hemorrhage: blood seen on initial head CT
Transient Ischemic attack: focal neurological deficit of likely ischemic vascular origin that has clinically resolved
Exclusion Criteria:
Pregnancy
Comfort or hospice care
Severe dementia prior to stroke
Non-communicative and have no family/social support
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott E Kasner, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Coordination and Transitions of Care in Stroke Patients
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