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CompletedNCT02642744Updated Feb 23, 2024Results posted

Improving Coordination and Transitions of Care in Stroke Patients

An interventional study of Nursing care model in Stroke and Transient Ischemic Attack, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
670
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Stroke
  • Transient Ischemic Attack
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 670 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnancy
  • Comfort or hospice care
  • Severe dementia prior to stroke
  • Non-communicative and have no family/social support
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
670 participants (actual)

Study arms

  • Other
    Attending nurse model

    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.

    Other: Nursing care model

  • No intervention
    Conventional inpatient nursing care

    Standard of care nursing care patients receive while inpatient

Interventions

  • OtherNursing care model

    Subjects will be randomized into either the attending nursing model of care vs the standard nursing model

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What researchers measure

Primary outcomes

  1. Stroke Patient Education Retention Tool

    measures patient knowledge about stroke

    Time frame: 90 days

  2. Medication Compliance

    medication adherence measurement

    Time frame: 90 Days

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Results

Posted Nov 8, 2023

Participant flow

Participant flow — Overall Study
MilestoneAttending Nurse ModelConventional Inpatient Nursing Care
Started278392
Completed129169
Not completed149223

Outcome measures

PrimaryStroke Patient Education Retention Tool

measures patient knowledge about stroke

Time frame:
90 days
Reported as:
Count of participants · Participants
Stroke Patient Education Retention Tool
ParticipantsAttending Nurse ModelConventional Inpatient Nursing Care
Good4952
Bad2938
PrimaryMedication Compliance

medication adherence measurement

Time frame:
90 Days
Reported as:
Count of participants · Participants
Medication Compliance
ParticipantsAttending Nurse ModelConventional Inpatient Nursing Care
Adherent5367
Non-adherent2927

Adverse events

Collected over Up to 90 days after admission. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Attending Nurse Model0/129 (0%)0/129 (0%)0/129 (0%)
Conventional Inpatient Nursing Care0/169 (0%)0/169 (0%)0/169 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Attending Nurse ModelConventional Inpatient Nursing CareTotal
Mean63 ± 1563 ± 1663 ± 16
Sex: Female, Male
Sex: Female, Male(Participants)Attending Nurse ModelConventional Inpatient Nursing CareTotal
Female5478132
Male7591166
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Attending Nurse ModelConventional Inpatient Nursing CareTotal
White, Non-Hispanic5174125
White, Hispanic235
African American, Non-Hispanic5757114
Asian257
Other162339
Missing178
Region of Enrollment
Region of Enrollment(participants)Attending Nurse ModelConventional Inpatient Nursing CareTotal
United States129169298
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Study locations

1 site
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 1, 2015

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02642744
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Dec 30, 2015
Start date
Oct 2015
Primary completion
Sep 30, 2017
Completion
Dec 2023
Results posted
Nov 8, 2023
Last update
Feb 23, 2024

Study contacts

Scott E Kasner, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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