Quality Improvement in Stroke Prevention (QUISP)

Ischemic Stroke Clinical Trial

Official title:

Secondary Prevention After Ischemic Stroke: A Trial of an Evidence-Based System-Wide Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00328640
• Other study ID #: MM 0620 0404
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2006
• Last updated: April 25, 2007
• Start date: December 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2007
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. Anticoagulation in patients with atrial fibrillation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Optimal treatment

Locations

Country	Name	City	State
United States	Kaiser-Permanente Division of Research	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication utilization
Primary	Best Practices
Primary	Recurrent stroke
Secondary	Mortality
Secondary	Morbidity
Secondary	Cost
Secondary	Hospital readmission