Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT): Phase Two (ANGEL-ACT II)

Capital Medical University

Status: Unknown

Conditions: Intracranial Artery Occlusion With Infarction (Disorder)

Treatments: Behavioral: ANGEL Intervention Package and Toolbox

Study type: Interventional

Funder types: Other

Identifiers

NCT04151589

2016YFC1301501-2

Details and patient eligibility

About

The study is the second phase of Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT).

During the first phase of the ANGEL-ACT (NCT03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in China have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment.

ANGEL-ACT II is a cluster randomized, parallel controlled study. The aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.

Full description

This is a prospective, multi-centre, cluster randomized, open label, parallel controlled study that enrolled patients with acute ischemic stroke who underwent endovascular treatment in about 34 hospitals in China. The ratio Interventional arm control arm is 1:1, which means 17 hospitals and 332 participants in each arm.

Enrollment: 664 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Investigational Sites Inclusion Criteria:

• Participated in the ANGEL-ACT registry study
• Secondary or tertiary hospitals
• Available of emergency department and neurology ward for stroke patients
• Must have 24 hours × 7 days emergency department for stroke
• Capable of rt-PA thrombolysis and endovascular treatment

Investigational Sites Exclusion Criteria

• Endovascular treatment volume < 20 per year
• Unwillingness to participate ANGEL-ACT II and follow the protocol
• Currently participating other stroke treatment improving program/project or similar clinical studies

Participant Inclusion Criteria

• Age ≥ 18 years old
• Admitted from emergency or outpatient department;
• Acue ischemic stroke with large artery occlusion
• Within 24 hours after the onset, and eligible for endovascular treatment.
• The patient or legal representative give written informed consent

Participant Exclusion Criteria:

• Unsuitable for this study investigators' discretion
• Progressive stroke or in-hospital stroke

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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664 participants in 2 patient groups

Interventional Site

Experimental group

Description:

The process below will be allocated in Interventional Sites: 1. At each interventional sites, implementing full assessment of current emergency work flow of acute ischemic stroke patients who eligible for endovascular treatment. All interventional sites would undergo assessment in order to form a baseline. 2. Drafting intervention approaches based on the assessment results of all interventional sites. These approaches are executable, reproducible, and measurable. 3. Emergency work flow management APP would be installed on smartphones of designated personnel at each interventional sites. 4. Both intervention approaches and APP would be incorporated with original work flow at each interventional site. 5. Training sessions would be held in interventional sites or online every 3 month once the patient enrolment begin. 6. Outcome data would be analysed and dispatched every 3 month for each interventional sites.

Treatment:

Behavioral: ANGEL Intervention Package and Toolbox

Control Site

No Intervention group

Description:

The control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.