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Completed

NCT Number: NCT02212912

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

About this study

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

Endpoints:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

improvement intervention

Behavioral

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

Behavioral

No intervention indicated that the physicians among control hospital provide routine

Primary outcomes

  1. 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.

  2. 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

  1. 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

    Time frame: 3,6,12 months

    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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: GoldenBridge

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 8, 2014
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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