Effectiveness of Implementing Best Care Practices in the Management of Patients With Acute Stroke in Conventional Hospitalization: A Cluster-Randomized, Open, Stepped-Wedge Controlled Trial.
| Registry | NCT07627399, acronym BESTCAREICTUS |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, sequential, masking: single, health services research |
| Enrollment | 700 (Estimated) |
| Sponsor | University of Malaga (Other); collaborators: Instituto de Salud Carlos III, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud, Andalusian Health Service |
| Conditions | Stroke, Acute Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular Disorders, Deglutition Disorders, Perceptual Disorders, Unilateral Neglect, Pneumonia, Aspiration |
| Interventions | BEST CARE ICTUS_HC BUNDLE (Other) |
| Dates | start 2026-05-12, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-06-04, last updated 2026-06-04 |
| Locations | 4 sites in Spain |
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All trials for Stroke All trials for Acute Stroke All trials of BEST CARE ICTUS_HC BUNDLE
The goal of this clinical trial is to evaluate whether a multicomponent nurse-led intervention (BEST CARE ICTUS_HC) can reduce stroke-related complications and improve recovery in adults (18 years and older) hospitalized with an acute ischemic or hemorrhagic stroke in hospitals without specialized Stroke Units. The main questions it aims to answer are:
1. Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia?
2. Does the program reduce the severity of attention problems (hemineglect) and improve the patients' quality of life up to 6 months after discharge?
Researchers will compare patients receiving the BEST CARE ICTUS_HC program to patients receiving usual hospital care to see if this new approach improves patient safety and long-term functional recovery.
Participants will:
* Receive either the usual hospital care for stroke or the BEST CARE ICTUS_HC nursing program, depending on the study phase of the hospital.
* Be screened for swallowing problems using a standardized test before receiving any food or drink.
* Be cared for in an adapted environment (FLECHA Project) that uses visual signs and room organization to help with orientation and safety.
* Have their temperature, blood sugar, and blood pressure monitored under a strict specialized protocol.
* Be contacted by phone 30 days and 6 months after leaving the hospital to answer questions about their health and quality of life.
#Background and Context# Significant disparities exist in acute stroke outcomes depending on the type of hospital where a patient is admitted. In the Province of Malaga, peripheral hospitals lack specialized Stroke Units, meaning patients are managed in general internal medicine or standard hospitalization wards. Evidence suggests that nurse-led protocols (such as the FeSS protocols) can reduce mortality and complications like Stroke-Associated Pneumonia (SAP), yet these are rarely standardized in non-specialized settings.
The BEST CARE ICTUS_HC model aims to bridge this gap by implementing a structured bundle of care designed to minimize preventable complications and standardize nursing excellence in these peripheral centers.
The study follows the RE-AIM framework to assess reach, effectiveness, adoption, implementation, and maintenance. In accordance with the RE-AIM framework, the study will go beyond mere clinical efficacy to analyze how the intervention's integration into routine practice modifies professional behaviors and healthcare delivery processes.
#Description of the intervention#
The intervention employs a five-pillar strategy to enhance patient safety and clinical outcomes:
1. Educational Outreach: Intensive training for nursing staff in peripheral wards on stroke pathophysiology and the "compensatory care" model.
2. Dysphagia and Complication Prevention: Systematic use of the Modified Swallowing Assessment (MSA) to prevent aspiration and pneumonia, replacing informal clinical judgment.
3. The "FLECHA" Project (Environmental Adaptation and Compensatory Care):
* Visual Signaling System: Use of standardized, color-coded pictograms and directional arrows placed at the patient's bedside. This system provides an immediate visual cue to healthcare staff and family members regarding the stroke-affected side, ensuring all interactions account for the patient's specific deficits.
* Therapeutic Spatial Reorganization: Strategic modification of the patient's immediate environment (arrangement of furniture, bedside tables, and personal items). This is designed to either encourage active visual scanning toward the neglected side (stimulation) or to safely compensate for the deficit, depending on the patient's clinical status and safety needs.
* Digital Integration of Personalized Care: Implementation of bedside QR codes that provide instant access to evidence-based nursing protocols. These digital care plans are tailored to the specific type of stroke and its lateralization, offering precise guidance on therapeutic positioning, safe mobilization techniques, and the management of invasive devices (e.g., catheters or IV lines) to prevent secondary complications.
4. Physiological Control Protocols: Algorithms for the strict monitoring of temperature, blood glucose, and blood pressure to prevent secondary brain injury.
5. Invasive Device Stewardship: Protocols for the early removal of catheters to reduce hospital-acquired infections and promote early mobilization.
The comparator will be the usual care provided by each unit. During the control period, hospitals will provide standard care according to their existing institutional protocols.
#Data Collection and Analysis# Data will be collected at baseline (admission), during hospitalization (daily monitoring), at discharge, and via follow-up (phone) at 30 days and 6 months. An "Intention-to-Treat" analysis will be performed using Generalized Linear Mixed Models (GLMM) to account for the clustering effect of hospitals and the time effect inherent in the stepped-wedge design.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No Intervention: usual care (control phase) | No intervention | Patients receive standard clinical care according to the existing protocols of each Internal Medicine Unit before the hospital crosses over to the intervention phase. In this phase, dysphagia screening is not standardized and relies on routine clinical assessment and medical history records. | |
| Experimental: BEST CARE ICTUS_HC (intervention phase) | Experimental | Other: BEST CARE ICTUS_HC BUNDLE | 1\) 3-hour training for staff on stroke care, dysphagia, and the "FLECHA" project. 2) Mandatory use of Modified Swallowing Assessment (MSA). 3) Compensatory care strategies (pictograms, spatial reorganization for hemineglect). 4) QR code-guided specific care plans. During the implementation, in addition to the educational intervention for nurses, several complementary strategies will be employed: local leadership, analysis of barriers and facilitators, audit and feedback, provision of resources and materials, evaluation of intervention fidelity, and outreach facilitation. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients aged 18 years or older. * Clinical diagnosis of acute ischemic or hemorrhagic stroke. * Admission to conventional hospitalization units (Internal Medicine) in regional hospitals without specialized Stroke Units. Exclusion Criteria: * Patients admitted for a cause other than stroke who develop a stroke during their hospital stay (in-hospital stroke). * Patients subjected to invasive neurological procedures. * Patients undergoing invasive procedures, such as thrombectomy, who require transfer to a referral hospital and remain there for more than 48 hours. * Patients with deterioration of the level of consciousness that prevents the performance of dysphagia testing. * Patients that have been taken care of by Nurses and Nursing Assistants with >4 weeks of work experience in Stroke Units in the last 12 months
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital de Antequera | Antequera, Málaga | Spain | Not yet recruiting |
| Hospital Universitario Costa del Sol | Marbella, Málaga | Spain | Not yet recruiting |
| Hospital de la Serranía de Ronda | Ronda, Málaga | Spain | Not yet recruiting |
| Hospital Comarcal de la Axarquia | Málaga, Velez-Maálaga | Spain | Recruiting |