Acute Ischemic Stroke
Conditions
Keywords
ischemic stroke, intravenous thrombolysis, endovascular treatment, medical quality, spatiotemporal computing
Brief summary
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) to promote the reconstruction of workflow in stroke centers and to shorten in-hospital delay of reperfusion treatment for AIS patients. This is a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of the FAST model.
Detailed description
This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model). Then a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of this FAST model. This study will recruit 20 secondary or tertiary hospitals that meet the inclusion criteria, mainly distributed in the Beijing-Tianjin-Hebei-Shanxi-Neimenggu region. After 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups. Then, the intervention group will install ithe intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 4 months. As the knowledge gained from the training may affect the identification of AIS patients, the duration of the training will keep as short as possible. We will conduct training to ensure that only trained caregivers and researchers master the use of the application to maintain the integrity of the intervention. During this 4-month period, both the control group and the intervention group will cease data collection. The FAST model intervention based on spatiotemporal computing technology will uniformly start after installation and training in each intervention group hospital. The intervention group will receive the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology for 8 months and collect information, mainly the critical time information of the AIS reperfusion therapy process. In the control group, only information will be collected. We will compare the critical treatment time information, Door to Needle time and Door to Puncture time, etc., between the two groups and conduct a 3-month follow-up.
Interventions
BEHAVIORALThe goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)
Spatiotemporal computing technology: Spatiotemporal positioning devices are installed in the emergency environment of the intervention hospitals in advance. Duration at each node of AIS patients wearing an intelligent bracelet will be calculated and displayed via the "Green Fast" mobile application. Time Target: According to the standardized procedure, we will preset the target times at the key nodes of reperfusion therapy workflow in the system in advance. Alert: Reminders or alerts will be triggered if duration at the node exceeds predefined targets. Feedback: The system is equipped with procedure feedback function to managers and users. The teams of intevention hospital will organize periodic regular meetings weekly and trial management group will participate in the meetings every two weeks. Using the data provided by the "Green Fast", problems existing in the treatment workflow will be identified and solved. A continuous PDCA cycle will be conducted for quality improvement.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
After 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups according to baseline DNT to reduce the imbalance between the two groups. We will not indicate to any hospital the grouping type of other hospitals. If the selected hospital is unable to complete the study for some reason during the operation, the hospital will be replaced with an eligible hospital of the same capacity. Masking of study and hospital personnel to assignment will be not possible because of the nature of the intervention. However, centralized follow-up interviewers assigned to assess the follow outcomes will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hospitals# 1. Secondary or tertiary public hospitals with an emergency department that receive patients with AIS. 2. Admit at least 50 patients of AIS within 4.5 hours after onset each month. 3. Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment. 4. Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures. 5. Have good cooperation relationship among the department of Neurology, Emergency, Interventional department, Neurosurgery department, Laboratory department and Radiology department. 6. Have ability to establish or participate in the establishment of patient information database and arrange a person responsible for the collection of case information. Patients# Patients who are ≥18 years old are eligible for inclusion if they present with AIS diagnosed by CT and/or MRI, arrive at hospital within 4.5 hours after symptom onset, sign the informed consent form and agree to follow up until 3 months after stroke onset.
Exclusion criteria
Hospitals# 1. Hospital that unable to cooperate and complete the research. 2. Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials. Patients# 1. Patients refuse to sign informed consent and follow up until 3 months after stroke onset. 2. Patients with mild nondisabling stroke (Defined as no measurable neurologic deficit, or NIHSS≤3 with only one of the following isolated symptoms: isolated facial paralysis; mild cortical blindness; mild hemianesthesia; mild hemiataxia.) 3. Life expectancy three-months or less by judgment of the investigator. 4. Participation in any interventional study that may affect the outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | — |
| The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | — |
| The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | — |
| Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy. | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | — |
| Proportion of patients with 90-day favorable functional outcome. | Participants will be followed for 3 month after stroke onset. | mRS 0-1 |
| Proportion of patients with 90-day independent functional outcome. | Participants will be followed for 3 month after stroke onset. | mRS 0-2 |
| in-hospital mortality | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | — |
| 90-day mortality | Participants will be followed for 3 month after stroke onset. | — |
Countries
China
Outcome results
None listed