Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4,800
- Locations
- 1
- Primary Endpoint
- percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications
Study Overview
Brief Summary
The purpose of this study is to evaluate whether a multifaceted quality improvement intervention can improve the adherent rate of individual and composite of evidence-based performance measures for patients with acute ischemic stroke within the first 7 days of symptom onset and reduce the incidence of a new clinical vascular event, disability, and all-cause mortality at discharge and long term clinical outcome.
Detailed Description
Study population:
patients with acute ischemic stroke who were admitted to the hospital within 7 days after the initial symptom onset.
Program:
There are multifaceted quality improvement interventions including:
- Evidence-based clinical pathway
- Standard operating procedures (SOP) of performance indicators
- A quality coordinator
- Monitoring and feedback system of performance measures
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Older than 18
- •Ischemic stroke within 7 days of the index event
- •Direct admission based on physician evaluation or arrival through the emergency department
- •Ability of patient or legally authorized representative to provide informed consent for 3, 6,and 12 months after initial symptom onset
- •Eligible events were confirmed by brain ct or mri within7 days after the onset of symptoms
Exclusion Criteria
- •Patients refuse to participate in this study
Outcomes
Primary Outcomes
percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The primary end point was all-or-none measure of evidence-based performance measures in patients without contraindications, at the emergency department (Intravenous tissue-type plasminogen activator (tPA) in patients who arrive within 2 hours after initial symptom onset and treated within 3 hours), during 48 hours after admission (antithrombotic drugs; dysphagia screening; deep venous thrombosis prophylaxis including pneumatic compression devices, subcutaneous unfractionated heparin, low molecular weight heparin, or full-dose anticoagulation (e.g., with heparin or warfarin)) , and at discharge (antithrombotic therapy, discharge on anticoagulation for patients with atrial fibrillation, and discharged on statin, antihypertensive, and hypoglycemic medications). An all-or-none measure of care was used, which is defined as the proportion of patients who received all of the performance measure interventions for which they were eligible.
a composite measure score of performance measures
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.
Secondary Outcomes
- percentage of new clinical vascular event (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death) , disability (disability defined as Modified Rankin Score (mRS) ≥ 2) , and all-cause mortality(3,6,12 months)
Investigators
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital