Ischemic StrokePhase 4NCT00328640
Quality Improvement in Stroke Prevention (QUISP)
A Phase 4 study testing Optimal treatment in people with Ischemic Stroke, run by University of California, San Francisco at 1 site in United States.
Trial summary
Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke: 1. Treatment with statins, 2. Control of hypertension, and 3. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Optimal treatment
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Mar 2007
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke Kaiser-Permanente Health Plan Member with Pharmacy Benefit Discharged alive to home
Who cannot join
- tpA patients Hemorrhagic stroke TIA Significant comorbidities
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser-Permanente Division of Research
Oakland, California, 94612
About this study
Official title: Secondary Prevention After Ischemic Stroke: A Trial of an Evidence-Based System-Wide Intervention
Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke:
- Treatment with statins,
- Control of hypertension, and
- Anticoagulation in patients with atrial fibrillation.
Read the detailed description
There are several proven strategies for prevention of recurrent ischemic stroke, including use of statins, treatment of hypertension, and anticoagulation in patients with atrial fibrillation. Preliminary analyses suggest that only 9-15% of Kaiser Permanente Northern California's ischemic stroke patients receive optimal care for secondary prevention of stroke. The purpose of this study is to determine whether or not a quality improvement (QI) intervention can improve the care received by stroke patients. This project consists of a randomized trial of standardized stroke discharge order forms to improve adherence with best practices in secondary stroke prevention. The primary research question is: Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke: (1) treatment with statins, (2) control of hypertension, and (3) anticoagulation in patients with atrial fibrillation.
The primary outcome will be the proportion of patients receiving optimal treatment, as defined by these three goals. The impact of the intervention will be measures as a change after-to-before at intervention hospitals compared to non-intervention (control) hospitals, with the institution as the unit of analysis. Secondary analyses will evaluate the impact of the intervention on each of these components and on 6-month and 1-year rates of mortality, readmission for stroke, and costs of care after discharge.
- Conditions
- Ischemic Stroke
- Being tested
- Optimal treatment
- Keywords
- CVA, Ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication utilization
Best Practices
Recurrent stroke
Secondary outcomes (4)
Mortality
Morbidity
Cost
Hospital readmission
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 startDec 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 1,500 participants
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Investigators
- David M Grosvenor, MPH, Study director, University of California, San FranciscoS C Johnston, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328640
- Sponsor's protocol ID
- MM 0620 0404
- Status last verified
- Apr 2007
- First submitted
- 18 May 2006
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johnston SC, Sidney S, Hills NK, Grosvenor D, Klingman JG, Bernstein A, Levin E. Standardized discharge orders after stroke: results of the quality improvement in stroke prevention (QUISP) cluster randomized trial. Ann Neurol. 2010 May;67(5):579-89. doi: 10.1002/ana.22019.
PubMed 20437555
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention After Ischemic Stroke: A Trial of an Evidence-Based System-Wide Intervention
- ClinicalTrials.gov ID
- NCT00328640
- Acronym / sponsor ID
- MM 0620 0404
- Conditions
- Ischemic Stroke
- Keywords
- CVA, Ischemic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Dec 2005
- Study completion
- Mar 2007 (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.
Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke:
- Treatment with statins,
- Control of hypertension, and
- Anticoagulation in patients with atrial fibrillation.
Detailed description
There are several proven strategies for prevention of recurrent ischemic stroke, including use of statins, treatment of hypertension, and anticoagulation in patients with atrial fibrillation. Preliminary analyses suggest that only 9-15% of Kaiser Permanente Northern California's ischemic stroke patients receive optimal care for secondary prevention of stroke. The purpose of this study is to determine whether or not a quality improvement (QI) intervention can improve the care received by stroke patients. This project consists of a randomized trial of standardized stroke discharge order forms to improve adherence with best practices in secondary stroke prevention. The primary research question is: Is a secondary prevention intervention, focused on implementation of standardized pre-printed discharge orders for hospitalists, effective at increasing utilization of the following evidence-based treatments 6 months after discharge for ischemic stroke: (1) treatment with statins, (2) control of hypertension, and (3) anticoagulation in patients with atrial fibrillation.
The primary outcome will be the proportion of patients receiving optimal treatment, as defined by these three goals. The impact of the intervention will be measures as a change after-to-before at intervention hospitals compared to non-intervention (control) hospitals, with the institution as the unit of analysis. Secondary analyses will evaluate the impact of the intervention on each of these components and on 6-month and 1-year rates of mortality, readmission for stroke, and costs of care after discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ischemic stroke Kaiser-Permanente Health Plan Member with Pharmacy Benefit Discharged alive to home
Key exclusion criteria (1 listed)
- tpA patients Hemorrhagic stroke TIA Significant comorbidities
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 |
|---|---|---|
| Optimal treatment | Drug | – |
Primary outcome
Medication utilization
Best Practices
Recurrent stroke
4 secondary outcomes
Mortality
Morbidity
Cost
Hospital readmission
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 27 Apr 2007.
- Derived from this study: PubMed 20437555Johnston SC, Sidney S, Hills NK, Grosvenor D, Klingman JG, Bernstein A, Levin E. Standardized discharge orders after stroke: results of the quality improvement in stroke prevention (QUISP) cluster randomized trial. Ann Neurol. 2010 May;67(5):579-89. doi: 10.1002/ana.22019.
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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.
David M Grosvenor, MPH study director
University of California, San Francisco
S C Johnston, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Optimal treatment in people with Ischemic Stroke, run by University of California, San Francisco 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 1 inclusion and 1 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 27 Apr 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Medication utilization. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328640, which also lists 1 linked publication.
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 27 Apr 2007.