Clinical trial NCT00328640: Quality Improvement in Stroke Prevention (QUISP)
Official title: Secondary Prevention After Ischemic Stroke: A Trial of an Evidence-Based System-Wide Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Stroke
Keywords: CVA
Ischemic stroke
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2006-05-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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:

1. Treatment with statins,
2. Control of hypertension, and
3. 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.

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

Primary outcomes:
measure: Medication utilization
measure: Best Practices
measure: Recurrent stroke
Secondary outcomes:
measure: Mortality
measure: Morbidity
measure: Cost
measure: Hospital readmission
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser-Permanente Division of Research
state: California
Study officials:
affiliation: University of California, San Francisco
name: David M Grosvenor, MPH
role: STUDY_DIRECTOR
affiliation: University of California, San Francisco
name: S C Johnston, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.