NORA-HOME: An Ambulatory Multimodal Monitoring Model In Patients With Minor Stroke And Transient Ischemic Attacks

Background: The risk of stroke recurrence is higher in patients who have previously experienced a minor or self-limited event. It is necessary to develop strategies that allow rapid evaluation of these patients and the early initiation of preventive treatment. However, early etiological study of these patients usually requires admission to an Acute Stroke Unit, which entails the cost of a potentially avoidable hospital stay, the inherent risks of hospitalization in fragile patients, and a suboptimal experience for both patients and their families. As an alternative to admission, these patients are discharged from the emergency department to be evaluated early on an outpatient basis in "TIA clinics," with suboptimal clinical and hemodynamic monitoring that does not effectively reduce the risk of early recurrence.

Hypothesis: Our hypothesis is that our Multimodal Home Hospitalization program (NORAHOME) for patients with TIA and minor stroke is safe, reduces the complications inherent to conventional hospitalization, and is more efficient than Standard Clinical Practice.

Objectives:

Primary: To validate that our Home Hospitalization program for patients with TIA or minor stroke (NORAHOME) is an efficient strategy compared to Standard Clinical Practice while maintaining the same level of patient safety.

Primary efficacy objective: Reduce the risk of early recurrence and hospital readmission compared to standard clinical practice.

Primary safety objective: No increase in the number of complications in patients with TIA/minor stroke (falls, recurrences, infections) compared to standard clinical practice.

Secondary:

Reduce direct hospital costs.

Improve patient-reported health outcomes (PROMS) and their experience with the healthcare system (PREMS) compared to standard clinical practice.

Reduce complications inherent to hospital admission (delirium, nosocomial infections, falls).

Improve knowledge about stroke and key secondary prevention recommendations after the acute stroke phase.

Improve control of vascular risk factors and treatment adherence after the acute stroke phase.

Improve assessment of basic (ADL) and instrumental activities of daily living (IADL) compared to standard clinical practice.

Evaluate point-of-care etiological diagnostic studies, including focused echocardiography and multimodal remote cardiac monitoring.

Methodology: This is a single-center, prospective, randomized study of consecutive patients with TIA and minor stroke admitted to the Emergency Department. After signing informed consent, patients will be consecutively randomized to the treatment group (NORAHOME) or the control group (Standard Clinical Practice). After completing a 3-month follow-up period, a comparative statistical analysis between the treatment and control groups will be conducted

Relevance: All guidelines recommend early management of TIA and minor stroke, but there is no consensus on the best care model. It is therefore necessary to develop fast-track pathways to dedicated facilities for evaluation, diagnosis, risk assessment of recurrence, and management of patients with TIA and minor stroke. If the study results confirm the hypothesis, in addition to reducing healthcare costs and relieving pressure on Stroke Units-given the increasing number of patients affected by this condition-it would demonstrate an improvement in the health and quality of life of these patients. The comprehensive care plan and technological development could also allow the inclusion of patients with more severe impairment, through the administration of telerehabilitation treatments (physiotherapy, speech therapy, and occupational therapy), ensuring proper follow-up and facilitating the patient's return to daily life.

Inclusion criteria

Patients presenting to the Emergency Department with symptoms of TIA (complete recovery of neurological deficits within <24 hours) or minor stroke (NIHSS ≤ 5)

• Age >18 years.
• Availability of a smartphone for the patient or caregiver.
• Family support and/or formal caregiver.
• Clinical stability during the last 12 hours in the Emergency Department.
• Signed informed consent by the patient and/or family member or legal representative.

Exclusion criteria

• Severe stenosis or symptomatic arterial occlusion requiring admission for potential reperfusion and/or arterial revascularization treatments.
• Patients with pre-existing neurological or psychiatric conditions that may interfere with or complicate follow-up and evaluations.
• Clinical (terminal condition) or social (language barrier) impossibility to complete follow-up assessments.