NCT02642744

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
670

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

November 8, 2023

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

December 24, 2015

Results QC Date

January 26, 2023

Last Update Submit

February 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stroke Patient Education Retention Tool

    measures patient knowledge about stroke

    90 days

  • Medication Compliance

    medication adherence measurement

    90 Days

Study Arms (2)

Attending nurse model

OTHER

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

Conventional inpatient nursing care

NO INTERVENTION

Standard of care nursing care patients receive while inpatient

Interventions

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

Attending nurse model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

Models, Nursing

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

Models, TheoreticalInvestigative Techniques

Results Point of Contact

Title
Laura Stein
Organization
University of Pennsylvania

Study Officials

  • Scott E Kasner, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2015

First Posted

December 30, 2015

Study Start

October 1, 2015

Primary Completion

September 30, 2017

Study Completion

December 1, 2023

Last Updated

February 23, 2024

Results First Posted

November 8, 2023

Record last verified: 2024-02

Locations