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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02212912
Acronym
GoldenBridge
Enrollment
4800
Registered
2014-08-08
Start date
2014-08-10
Completion date
2016-07-30
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke, performance measure, acute treatment

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: 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

Interventions

BEHAVIORALimprovement 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.

BEHAVIORALno intervention

No intervention indicated that the physicians among control hospital provide routine

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindicationsparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksThe 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 measuresparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksa 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

MeasureTime frameDescription
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 mortality3,6,12 monthsThe 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.

Other

MeasureTime frameDescription
a composite measure score of performance measuresparticipants will be followed for the duration of hospital stay, an expected average of 2 weeksa 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026