Ischemic Stroke, Retinal Ischemia, Transient Ischemic Attack (TIA)
Conditions
Keywords
Ambulatory Stroke Unit, Stroke Unit Care, Minor Stroke, Transient Ischemic Attack, Geriatric Stroke, Non-Inferiority Trial, Health Services Research, Care Delivery Model, Integrated Stroke Care, Post-Stroke Outcome, Modified Rankin Scale, Quality of Life, Cost-Effectiveness, Stroke Recurrence, Delirium
Brief summary
ARTIFICE is a prospective, multicenter, randomized, controlled, exploratory non-inferiority trial evaluating whether an ambulatory stroke unit model (aSU) is non-inferior to conventional inpatient stroke unit care (SU) in patients aged 60 years or older with acute ischemic stroke, transient ischemic attack (TIA), or retinal ischemia and non-disabling neurological deficits. Eligible patients are randomized 1:1 to same-day comprehensive ambulatory multiprofessional stroke evaluation (aSU) or guideline-based inpatient stroke unit treatment (SU). The primary endpoint is favorable functional outcome at 90 days, defined as modified Rankin Scale (mRS) 0-2 or return to pre-stroke mRS. Endpoint assessment at 90 days is performed by blinded assessors (PROBE design). Secondary outcomes include early neurological deterioration, recurrent stroke, delirium, mortality, health-related quality of life, healthcare utilization, and cost-effectiveness. A mixed-methods process evaluation examines feasibility, acceptability, and implementation aspects of the ambulatory care model.
Detailed description
Stroke unit treatment in Germany is currently organized as multi-day inpatient care regardless of stroke severity. However, a substantial proportion of patients with acute ischemic stroke or transient ischemic attack present with non-disabling or fully regressed neurological deficits and may not require prolonged inpatient monitoring. At the same time, demographic changes and increasing stroke incidence in older populations challenge inpatient stroke unit capacity and resource allocation. International experience with structured outpatient TIA and minor stroke clinics suggests that ambulatory management models may provide comparable clinical safety while reducing hospital utilization. However, randomized evidence for such models within the German healthcare system is lacking. The ARTIFICE trial evaluates a structured ambulatory stroke unit care model designed to provide comprehensive same-day multiprofessional assessment and initiation of secondary prevention while maintaining patient safety. The study investigates whether this ambulatory care approach can represent a medically safe and resource-efficient alternative to conventional inpatient stroke unit treatment in selected older patients. In addition to clinical effectiveness, the study examines patient-reported outcomes, healthcare utilization, cost-effectiveness, and implementation aspects to inform future health services planning.
Interventions
OTHERAmbulatory Stroke Unit Care
Structured ambulatory stroke care model providing same-day neurological assessment, diagnostic work-up, therapeutic evaluation, and multidisciplinary case review, followed by discharge home if medically appropriate.
OTHERConventional Stroke Unit Care
Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.
Sponsors
University Hospital Heidelberg
Heidelberg University Hospital - Coordination Centre for Clinical Trials (KKS)
inav - Institute for Applied Health Services Research GmbH, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open-label study due to the nature of the care setting. Outcome assessment at 90 days is performed by independent study personnel who are blinded to treatment allocation (PROBE design).
Intervention model description
Participants aged ≥60 years with acute ischemic stroke, transient ischemic attack, or retinal ischemia and non-disabling neurological deficits are randomized 1:1 to ambulatory stroke unit care or guideline-based inpatient stroke unit care after confirmation that both treatment settings are medically feasible. Randomization is computer-generated, block-based, and stratified by baseline modified Rankin Scale (0-3 vs 4-5).
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years * Diagnosis of acute ischemic stroke (ICD-10 I63.), transient ischemic attack (G45.), or retinal ischemia (H34.\*) * Symptom onset ≤ 7 days before enrollment * No or non-disabling newly occurring neurological deficit allowing safe ambulatory management * Written informed consent provided by the participant or, if lacking decision-making capacity, by a legally authorized representative
Exclusion criteria
* Requirement for urgent surgical or interventional secondary prevention (e.g., carotid revascularization) * Fluctuating stroke symptoms within the previous 48 hours * Acute febrile infection or isolation-requiring infectious disease * Clinically relevant dysphagia with high aspiration risk * Critical medical or nursing findings requiring mandatory multi-day inpatient treatment * Palliative care situation with limitation of acute diagnostic or therapeutic measures * Previous participation in the ambulatory stroke unit care model * No statutory health insurance coverage in Germany * Insufficient German language proficiency to understand study procedures and assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable Functional Outcome at 90 Days | 90 days (±14 days) after randomization | Favorable functional outcome defined as modified Rankin Scale (mRS) score 0-2 or return to pre-stroke mRS level, assessed by blinded outcome assessors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early Neurological Deterioration | Within 7 days after randomization | Increase in National Institutes of Health Stroke Scale (NIHSS) score of ≥4 points compared to baseline. |
| Recurrent Stroke | Up to 90 days after randomization (primary safety observation period) | Occurrence of recurrent ischemic stroke, hemorrhagic stroke, or transient ischemic attack during follow-up. |
| Delirium Occurrence | Within 7 days after randomization | Occurrence of delirium assessed using the Confusion Assessment Method (CAM). |
| All-Cause Mortality | 90 days and 12 months after randomization | Death from any cause. |
| Functional Status | Baseline and 90 days | Change in Barthel Index score from baseline to 90 days. |
| Stroke Impact | Baseline and 90 days | Change in SIS-16 score from baseline to 90 days. |
| Mobility | Baseline and 90 days | Change in Timed Up and Go Test (TUG) time from baseline to 90 days. |
| Health-Related Quality of Life | Baseline and 90 days | Change in EQ-5D-5L index value and EQ visual analogue scale (EQ-VAS) from baseline to 90 days. |
| Healthcare Utilization | Up to 90 days after randomization | Use of outpatient, inpatient, and nursing care services assessed by questionnaire. |
| Serious Adverse Events | Up to 90 days after randomization | Occurrence of serious adverse events including unplanned hospitalization or death. |
Countries
Germany
Contacts
CONTACTJan C Purrucker, Prof. Dr.
Outcome results
None listed