Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will conduct a cluster randomized controlled trial to Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Large scale randomized trials and systematic reviews have established the efficacy of lipid lowering therapy for acute ischemic stroke. However, adherence to these evidence-based performance measures is suboptimal and gaps in adherence to guideline recommended care are even greater in China. Multifaceted quality improvement interventions that address the barriers to care are effective in changing physician practices. Quality improvement interventions have demonstrated that stroke care quality can be improved by conducting interventions such as using clinical pathways, training physicians on evidence-based guidelines, auditing care delivery, and providing timely feedback.
Aim: To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post-intervention.
Intervention: The Intelligent Lipid Management Decision-support System primarily consists of an evidence-based clinical pathway. The evidence-based clinical pathway was written by a panel of stroke experts according to the published statements in peer-reviewed literature, consensus statements and guidelines. It was integrated into the care plan of each eligible stroke admission.
Eligible hospitals in china, stratified by economic-geographical regions, will be randomized into either the intervention group or the control group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Intelligent Lipid Management Decision-support System | Experimental | Doctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance. |
|
| Usual Care | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the Intelligent Lipid Management Decision-support System | Device | Doctor's Side: Long-term lipid management support based on guidelines/consensus• Provides lipid management pathways based on guidelines/consensus to ensure clinical decisions align with the latest standards.• Combines individualized patient data to offer intelligent lipid management and medication suggestions.• Provides medical education support to enhance doctors' awareness of guidelines, consensus, and management strategies.Patient's Side: Personalized lipid risk assessment and regular reminders• Based on the lipid test reports uploaded by patients via photos, provides lipid test reports tailored to the patient's risk stratification.• Uses digital tools to regularly remind patients, optimizing follow-up adherence and medication compliance. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 1 year with Evolocumab treatment | To Evaluate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients 1-year target achievement (<1.8 mmol/L) in acute ischemic stroke or TIA patients under Evolocumab treatment within 12 months post. | at 365 days (±14days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage decrease from baseline in LDL-C at each visit (3 months and 12 months). | To investigate the LDL-C percentage decrease from baseline in patients with ischemic stroke or TIA using Evolocumab at 3 months and 12 months. | at 90 days (±7 days) and 365 days (±14 days) |
| Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) within 12 months post-intervention. |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Xu | Contact | 59975672 | xujie@ncrcnd.org.cn | |
| Aichun Cheng | Contact | 13240768490 | aichuncheng0822@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongjun Wang | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Duration (in months) of maintaining LDL-C levels within the target range (<1.8 mmol/L) among patients receiving Evolocumab treatment, within 12 months post-intervention. |
| at 365 days (±14 days) |
| Proportion of acute ischemic stroke or TIA patients achieving LDL-C <1.8 mmol/L at 3 months with Evolocumab treatment | To investigate whether the Intelligent Lipid Management Decision-support System can increase the proportion of patients achieving target LDL-C levels at 3 months under Evolocumab treatment with ischemic stroke or TIA in China | at 90 days(±7 days) |
| Frequency of subcutaneous Evolocumab injections at 3-month follow-up | Frequency of subcutaneous Evolocumab injections at 3-month follow-up as a measure of treatment persistence in ischemic stroke/TIA patients | at 90 days (±7 days) |
| Incidence rate of stroke recurrence and cardiovascular outcome events | Stroke recurrence and cardiovascular outcome events at each visit (3 months and 12 months) following the administration of Evolocumab in patients with ischemic stroke or TIA. | at 90 days (±7 days) and 365 days (± 14 days) |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
Not provided
Not provided