NCT03684629

Brief Summary

Study is designed for two parts, a perspective, multi-center, historial control study and a randomized controlled study of acute ischemic stroke patients. For achieving the target of diagnosis and treatment KPI (Key performance indicator) of AIS patients and improving the defects of the traditional working mode, our center developed the medical records data acquisition and KPI statistics system based on computer scan. This method guarantees the authenticity of the data, It computes the KPI of the corresponding medical institutions in the corresponding period and gives feedback on a regular basis. Based on the KPI feedback system, a multifaceted quality improvement intervention is conducted in the intervention group hospitals. This study aims to explore whether this new working mode can continuously improve the overall KPI in Zhejiang province, and thus reflect the improvement of quality and standardization of medical service in AIS patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,570

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 23, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

September 24, 2018

Last Update Submit

November 21, 2022

Conditions

Acute Ischemic Stroke and Transient Ischemic Attacks

Outcome Measures

Primary Outcomes (9)

  • Rate of neurological deficit score

    the rate of the case number of cerebral infarction patients who have completed the National Institutes of Health Stroke Scale (NIHSS) at the time of admission in the total number of cerebral infarction patients hospitalized in the same period

    six month

  • Rate of intravenous tPA within therapeutic time windows at symptom onset

    the rate of AIS patients who received intravenous recombinant tissue plasminogen activator (rt-pa) thrombolytic therapy within therapeutic time windows at symptom onset in patients with cerebral infarction

    six month

  • Rate of administration of aspirin or other antiplatelet agents within 48 hours of admission

    The rate of patients who received aspirin or other antiplatelet agents within 48 hours of admission to the hospital in the total number of cerebral infarction patients hospitalized in the same period

    six month

  • Rate of statin use during hospitalization

    The rate of patients hospitalized for cerebral infarction who were treated with statins in the total number of cerebral infarction patients hospitalized in the same period

    six month

  • Rate of statin treatment at discharge

    The rate of patients with cerebral infarction who received statin at discharge in the total number of patients with non-cardiac infarction who were hospitalized in the same period

    six month

  • Rate of antithrombotic therapy at discharge

    The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.

    six month

  • Rate of anticoagulant treatment for patients with atrial fibrillation at discharge

    The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period

    six month

  • 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

  • a all-or-none measure of evidence-based performance measures

    the all-or-none measure was defined as the proportion of patients who received all of the performance measures for which the patient was eligible.

    participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (15)

  • Rate of prevention of deep vein thrombosis

    six month

  • Rate of blood vessel assessment within one week of hospitalization

    six month

  • Rate of swallowing function evaluation

    six month

  • Rate of lipid level assessment

    six month

  • Rate of rehabilitation evaluation and implementation

    six month

  • +10 more secondary outcomes

Study Arms (2)

the response of KPI and corresponding suggestion

EXPERIMENTAL

The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month. The multifaceted quality improvement interventions include: 1) implementation of standardized templates of medical record, evidence-based clinical pathway, and written care protocols; 2) feedback system of performance measures; 3) expert online consultation.

Behavioral: the response of KPI and corresponding suggestion

a control arm

NO INTERVENTION

The control group indicated that the hospitals will not be provided with the multifaceted quality improvement interventions. They just provide patients with routine care.

Interventions

the response of KPI and corresponding suggestionBEHAVIORAL

Standardized templates of medical record, evidence-based clinical pathway, and written care protocols are applied in all hospitals.The KPI of the AIS patients who were admitted to a single hospital continuously at the time of hospitalization were studied. Feedback system of performance measures: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system since that month into the group. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the corresponding monthly KPI. The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Expert online consultation: based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month.

the response of KPI and corresponding suggestion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute ischemic stroke or transient ischemic attacks patients

You may not qualify if:

  • patients who losing his medical record of having the incomplete medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hosipital of Zhejiang University

Zhejiang, China

RECRUITING

Related Publications (1)

  • Chen Y, Zhong W, Gong X, Hu H, Yan S, Zhang X, Chen Z, Zhou Y, Lou M. Rationale and design of individualized quality improvement based on the Computer Analysing system to improve Stroke management quality Evaluation (CASE): a multicenter historically controlled study. Trials. 2020 Jul 24;21(1):677. doi: 10.1186/s13063-020-04598-3.

    PMID: 32709249DERIVED

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Lou Min, Ph.D

    The second affiliated hosipital of Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Lou Min, Ph.D

CONTACT

8613738085675loumingxc@vip.sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2018

First Posted

September 26, 2018

Study Start

August 1, 2018

Primary Completion

January 31, 2020

Study Completion

December 31, 2023

Last Updated

November 23, 2022

Record last verified: 2022-11

Locations

CN(1)