Ambulatory Stroke Unit Treatment for Elderly Patients

Official title

Ambulatory Stroke Unit Treatment for Elderly Patients: A Prospective, Randomized, Controlled, Exploratory Non-Inferiority Trial (ARTIFICE)

Overview

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

• Other Ambulatory 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.
• Other Conventional Stroke Unit Care
  Standard inpatient stroke unit treatment according to national clinical guidelines, including hospital-based monitoring, diagnostic evaluation, and initiation of secondary prevention.

Primary outcome measures

• Favorable Functional Outcome at 90 Days [Time frame: 90 days (±14 days) after randomization]

Secondary outcome measures (10)

• Early Neurological Deterioration [Time frame: Within 7 days after randomization]
• Recurrent Stroke [Time frame: Up to 90 days after randomization (primary safety observation period)]
• Delirium Occurrence [Time frame: Within 7 days after randomization]
• All-Cause Mortality [Time frame: 90 days and 12 months after randomization]
• Functional Status [Time frame: Baseline and 90 days]
• Stroke Impact [Time frame: Baseline and 90 days]
• Mobility [Time frame: Baseline and 90 days]
• Health-Related Quality of Life [Time frame: Baseline and 90 days]
• Healthcare Utilization [Time frame: Up to 90 days after randomization]
• Serious Adverse Events [Time frame: Up to 90 days after randomization]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Health services research

Study locations

Germany · 1 center

• Heidelberg University Hospital — Heidelberg

Identifiers

NCT: NCT07420374 · S-689/2025 (ARTIFICE) · 01NVF24306

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗