Cerebrovascular AccidentNCT00328471
A Post Discharge Intervention to Improve Stroke Outcomes
A study testing care management in people with Cerebrovascular Accident, run by Summa Health System.
Trial summary
The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- care management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of ischemic stroke. NIH Stroke Scale score >1. Discharged to home from the acute care hospital, or discharged to home within 4 weeks from a short term skilled nursing facility (SNF) or acute rehabilitation facility.
- Live within 25 miles of the study site. English speaking. Do not have an endarterectomy planned at the time of discharge to home.
Who cannot join
- Has other illness that would dominate post-stroke care (e.g., terminal diagnosis, dialysis patient, severe dementia/Alzheimer's disease).
- -
About this study
The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care.
Read the detailed description
The major components of the model of post-stroke care being tested include equal emphasis on physical and psychosocial issues known to impact stroke outcomes, an Advanced Practice Nurse care manager (APN-CM), an interdisciplinary healthcare team, evidenced-based care plans, collaboration with the patient's primary care physician (PCP), and ongoing patient monitoring. The APN-CM will work as part of an interdisciplinary post-stroke consultation team (PSC-Team) that will review problems identified at an in-home patient assessment. The core PSC-Team will include a geriatrician, a community-based general internist, a Clinical Nurse Specialist from the acute stroke unit, the APN-CM, and a physical therapist. Extended team members will be available as-needed and will include a neurologist, pharmacist, physiatrist, social worker, speech therapist, occupational therapist, and dietitian. The PSC-Team will develop patient care plans specific to each problem identified by the APN-CM. A copy of the care plans, evidence-based guidelines, pertinent references, and a short paragraph providing "academic detailing" specific to the patient's problems will be given to the patient's PCP by phone and in writing. The APN-CM will work collaboratively with the PCP to implement the recommendations and provide ongoing monitoring.The primary outcome of overall well-being of stroke survivors will be obtained at 6 months.
- Conditions
- Cerebrovascular Accident
- Being tested
- care management
- Keywords
- patient care management, cerebrovascular accident
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
care managementBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startJun 2002
- Primary completionJan 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Investigators
- Kyle R Allen, DO, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328471
- Sponsor's protocol ID
- 1R01NS041333-01A1
- Other IDs
- 1R01NS041333-01A1
- Status last verified
- Jan 2012
- First submitted
- 18 May 2006
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Allen KR, Hazelett SE, Palmer RR, Jarjoura DG, Wickstrom GC, Weinhardt JA, Lada R, Holder CM, Counsell SR. Developing a stroke unit using the acute care for elders intervention and model of care. J Am Geriatr Soc. 2003 Nov;51(11):1660-7. doi: 10.1046/j.1532-5415.2003.51521.x.
PubMed 14687400Allen KR, Hazelett S, Jarjoura D, Wickstrom GC, Hua K, Weinhardt J, Wright K. Effectiveness of a postdischarge care management model for stroke and transient ischemic attack: a randomized trial. J Stroke Cerebrovasc Dis. 2002 Mar-Apr;11(2):88-98. doi: 10.1053/jscd.2002.127106.
PubMed 17903862Allen KR, Hazelett SE, Jarjoura DG, Wright K, Clough L, Weinhardt J. Improving stroke outcomes: implementation of a postdischarge care management model. Journal of clinical outocmes management 11(11):707-714,2004.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Discharge Intervention to Improve Stroke Outcomes
- ClinicalTrials.gov ID
- NCT00328471
- Acronym / sponsor ID
- 1R01NS041333-01A1
- Conditions
- Cerebrovascular Accident
- Keywords
- patient care management, cerebrovascular accident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care.
Detailed description
The major components of the model of post-stroke care being tested include equal emphasis on physical and psychosocial issues known to impact stroke outcomes, an Advanced Practice Nurse care manager (APN-CM), an interdisciplinary healthcare team, evidenced-based care plans, collaboration with the patient's primary care physician (PCP), and ongoing patient monitoring. The APN-CM will work as part of an interdisciplinary post-stroke consultation team (PSC-Team) that will review problems identified at an in-home patient assessment. The core PSC-Team will include a geriatrician, a community-based general internist, a Clinical Nurse Specialist from the acute stroke unit, the APN-CM, and a physical therapist. Extended team members will be available as-needed and will include a neurologist, pharmacist, physiatrist, social worker, speech therapist, occupational therapist, and dietitian. The PSC-Team will develop patient care plans specific to each problem identified by the APN-CM. A copy of the care plans, evidence-based guidelines, pertinent references, and a short paragraph providing "academic detailing" specific to the patient's problems will be given to the patient's PCP by phone and in writing. The APN-CM will work collaboratively with the PCP to implement the recommendations and provide ongoing monitoring.The primary outcome of overall well-being of stroke survivors will be obtained at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of ischemic stroke. NIH Stroke Scale score >1. Discharged to home from the acute care hospital, or discharged to home within 4 weeks from a short term skilled nursing facility (SNF) or acute rehabilitation facility.
- Live within 25 miles of the study site. English speaking. Do not have an endarterectomy planned at the time of discharge to home.
Key exclusion criteria (2 listed)
- Has other illness that would dominate post-stroke care (e.g., terminal diagnosis, dialysis patient, severe dementia/Alzheimer's disease).
- -
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 |
|---|---|---|
| care management | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
- Results publication: PubMed 14687400Allen KR, Hazelett SE, Palmer RR, Jarjoura DG, Wickstrom GC, Weinhardt JA, Lada R, Holder CM, Counsell SR. Developing a stroke unit using the acute care for elders intervention and model of care. J Am Geriatr Soc. 2003 Nov;51(11):1660-7. doi: 10.1046/j.1532-5415.2003.51521.x.
- Results publication: PubMed 17903862Allen KR, Hazelett S, Jarjoura D, Wickstrom GC, Hua K, Weinhardt J, Wright K. Effectiveness of a postdischarge care management model for stroke and transient ischemic attack: a randomized trial. J Stroke Cerebrovasc Dis. 2002 Mar-Apr;11(2):88-98. doi: 10.1053/jscd.2002.127106.
- Results publicationAllen KR, Hazelett SE, Jarjoura DG, Wright K, Clough L, Weinhardt J. Improving stroke outcomes: implementation of a postdischarge care management model. Journal of clinical outocmes management 11(11):707-714,2004.
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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.
Kyle R Allen, DO principal investigator
Summa Health System
Questions about this trial
What is this clinical trial studying?
A study testing care management in people with Cerebrovascular Accident, run by Summa Health System.
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 2 inclusion and 2 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 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328471, which also lists 3 linked publications.
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 9 Jan 2012.