Quality Improvement in Stroke Prevention (QUISP) | NCT00328640

Studies
Quality Improvement in Stroke Prevention (QUISP)

NCT00328640

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Apr 27, 2007Estimated

Enrollment

1,500

Phase

Phase 4

Conditions

Ischemic Stroke

Interventions

Optimal treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2005

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

May 18, 2006

First Submission Date that Met QC Criteria

May 18, 2006

First Posted Date

May 22, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2007

Last Update Posted Date

Apr 27, 2007Estimated

Name	Class
Kaiser Permanente	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500

Name	Type	Description	Arm Group Labels	Other Names
Optimal treatment	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Medication utilization
Best Practices
Recurrent stroke

Secondary Outcomes

Measure	Description	Time Frame
Mortality
Morbidity
Cost

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ischemic stroke Kaiser-Permanente Health Plan Member with Pharmacy Benefit Discharged alive to home

Exclusion Criteria:

tpA patients Hemorrhagic stroke TIA Significant comorbidities

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David M Grosvenor, MPH	University of California, San Francisco	Study Director
S C Johnston, MD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser-Permanente Division of Research		Oakland	California	94612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20437555	Derived	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.

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases