Clinical trial NCT02212912: Intervention to Bridge the Evidence-based Gap in Stroke Care Quality
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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke, performance measure, acute treatment
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 4800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

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

Primary outcomes:
measure: percentage of all-or-none measure of evidence-based performance measures in acute ischemic stroke patients without contraindications
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: a composite measure score of performance measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: 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
timeFrame: 3,6,12 months
Other outcomes:
measure: a composite measure score of performance measures
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Yilong Wang, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Yongjun Wang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.