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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
improvement intervention
no intervention
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, performance measure, acute treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Tian Tan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Improvement intervention

no intervention

Arm Description

Improvement intervention is a multifaceted quality improvement method including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.

The control group indicated that the physicians will not be provided with the information of multifacet improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 2, 2014
Last Updated
July 10, 2020
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02212912
Brief Title
Intervention to Bridge the Evidence-based Gap in Stroke Care Quality
Acronym
GoldenBridge
Official Title
Cluster-randomized Trial of a Targeted Multifaceted Intervention to Bridge the Evidence-based Gap in the Management of Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 10, 2014 (Actual)
Primary Completion Date
June 20, 2015 (Actual)
Study Completion Date
July 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke, performance measure, acute treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Improvement intervention
Arm Type
Other
Arm Description
Improvement intervention is a multifaceted quality improvement method including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.
Arm Title
no intervention
Arm Type
Other
Arm Description
The control group indicated that the physicians will not be provided with the information of multifacet improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care
Intervention Type
Behavioral
Intervention Name(s)
improvement intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
no intervention
Intervention Description
No intervention indicated that the physicians among control hospital provide routine
Primary Outcome Measure Information:
Title
percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
a composite measure score of performance measures
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
3,6,12 months
Other Pre-specified Outcome Measures:
Title
a composite measure score of performance measures
Description
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.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yilong Wang, M.D
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, M.D
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tian Tan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29959443
Citation
Wang Y, Li Z, Zhao X, Wang C, Wang X, Wang D, Liang L, Liu L, Wang C, Li H, Shen H, Bettger J, Pan Y, Jiang Y, Yang X, Zhang C, Han X, Meng X, Yang X, Kang H, Yuan W, Fonarow GC, Peterson ED, Schwamm LH, Xian Y, Wang Y; GOLDEN BRIDGE-AIS Investigators. Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial. JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802.
Results Reference
derived
PubMed Identifier
26027613
Citation
Wang Y, Li Z, Xian Y, Zhao X, Li H, Shen H, Wang C, Liu L, Wang C, Pan Y, Wang D, Prvu Bettger J, Fonarow GC, Schwamm LH, Smith SC Jr, Peterson ED, Wang Y; GOLDEN BRIDGE-AIS investigators. Rationale and design of a cluster-randomized multifaceted intervention trial to improve stroke care quality in China: The GOLDEN BRIDGE-Acute Ischemic Stroke. Am Heart J. 2015 Jun;169(6):767-774.e2. doi: 10.1016/j.ahj.2015.03.008. Epub 2015 Mar 26.
Results Reference
derived

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

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