StrokeNCT02642744
Improving Coordination and Transitions of Care in Stroke Patients
A study testing Nursing care model in people with Stroke and Transient Ischemic Attack, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Transient Ischemic Attack
- What is being tested?
- Nursing care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 670 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- Pregnancy
- Comfort or hospice care
- Severe dementia prior to stroke
- Non-communicative and have no family/social support
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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
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.
- Conditions
- Stroke, Transient Ischemic Attack
- Being tested
- Nursing care model
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing care modelOther
Subjects will be randomized into either the attending nursing model of care vs the standard nursing model
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Nursing care model |
| Conventional inpatient nursing care | No intervention | Standard of care nursing care patients receive while inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke Patient Education Retention Tool
measures patient knowledge about stroke
Measured: 90 days
Medication Compliance
medication adherence measurement
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion30 Sep 2017
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott E Kasner, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642744
- Sponsor's protocol ID
- 823366
- Status last verified
- Feb 2024
- First submitted
- 24 Dec 2015
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02642744
- Acronym / sponsor ID
- 823366
- Conditions
- Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 8 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attending nurse model | Other | Other: Nursing care modelThe 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. |
| Conventional inpatient nursing care | No intervention | –Standard of care nursing care patients receive while inpatient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (4 listed)
- Pregnancy
- Comfort or hospice care
- Severe dementia prior to stroke
- Non-communicative and have no family/social support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing care modelSubjects will be randomized into either the attending nursing model of care vs the standard nursing model | Other | Attending nurse model |
Primary outcome
Stroke Patient Education Retention Tool
Time frame: 90 days
measures patient knowledge about stroke
Medication Compliance
Time frame: 90 Days
medication adherence measurement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott E Kasner, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing care model in people with Stroke and Transient Ischemic Attack, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke Patient Education Retention Tool (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.