Intervention to Bridge the Evidence-based Gap in Stroke Care Quality

Ischemic Stroke Clinical Trial

— GoldenBridge  

Official title:

Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212912
• Other study ID #: aic2014
• Status: Completed
• Phase: N/A
• Start date: August 10, 2014
• Est. completion date: July 30, 2016

Study information

• Verified date: July 2020
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Evidence-based clinical pathway

2. Standard operating procedures (SOP) of performance indicators

3. A quality coordinator

4. Monitoring and feedback system of performance measures

Endpoints:

Primary outcome:increase of adherence of evidence based treatment in clinical practice; Secondary outcome: total mortality, disability, and major cerebrovascular events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4800
• Est. completion date: July 30, 2016
• Est. primary completion date: June 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• improvement intervention
Evidence-based clinical pathway: It contained general guideline-based recommendations about acute stroke management. Standard operating procedures (SOP) of performance indicators. A quality coordinator:The role of the quality coordinator includes interacting with physicians once gaps in the incorporation of evidence-based interventions are identified, ensuring that all components of the quality improvement intervention are being used for every acute ischemic stroke (AIS) patient.Monitoring and feedback system of performance measures. The system could view the level of implementation of prespecified performance measures at any time (per week recommended) , compare with the previous record of own study site and level of other clusters.
• no intervention
No intervention indicated that the physicians among control hospital provide routine

Locations

Country	Name	City	State
China	Beijing Tian Tan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	a composite measure score of performance measures	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.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Primary	percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications	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.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Primary	a composite measure score of performance measures	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.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	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	The secondary primary end point was a 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 at discharge,3, 6, 12-months after initial symptom onset.	3,6,12 months