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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
700
Multicomponent nursing intervention including: 1) Specialized staff training on acute stroke care. 2) Systematic dysphagia screening using the Modified Swallowing Assessment (MSA). 3) Implementation of the "FLECHA Project", a compensatory care model that harmonizes all care delivery based on stroke laterality aimed at developing early functional rehabilitation for unilateral neglect, hemiplegia, hemiparesis, and anosognosia (strategies include use of bedside pictograms, spatial reorganization, and QR-guided specific care plans). 4) Protocols for physiological stability monitoring and early device removal.
Hospital de Antequera
Antequera, Málaga, Spain
NOT_YET_RECRUITINGHospital Universitario Costa del Sol
Marbella, Málaga, Spain
NOT_YET_RECRUITINGHospital de la Serranía de Ronda
Ronda, Málaga, Spain
NOT_YET_RECRUITINGHospital Comarcal de la Axarquia
Málaga, Velez-Maálaga, Spain
RECRUITINGProportion of participants with detected post-stroke dysphagia
Identification of swallowing difficulties. Control Group: Dyspaghia detection based on usual care (standard clinical observation and records). Intervention Group: Dysphagia detection using the Modified Swallowing Assessment (MSA) tool.
Time frame: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).
Catherine Bergego Scale (CBS) score for Hemineglect
The CBS is a functional assessment of unilateral neglect. It consists of 10 items related to daily living activities. Scores range from 0 to 30, where 0 indicates no neglect and 30 indicates severe neglect.
Time frame: At hospital admission (baseline) and at hospital discharge (average of 9 days).
Health-Related Quality of Life (HRQoL).
Measured using the SF-36 Health Survey in both groups. The survey covers eight health domains, with scores ranging from 0 to 100 (higher scores indicate better health status).
Time frame: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Mortality
Incidence of death from any cause in both groups.
Time frame: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Mean Systolic Blood Pressure during hospitalization.
Average of systolic blood pressure readings recorded to assess physiological stability. Unit of measurement: millimeters of mercury (mmHg).
Time frame: From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Body Temperature during hospitalization.
Average of body temperature readings measured daily. Unit of measurement: degrees Celsius (°C).
Time frame: From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Capillary Glycemia during hospitalization.
Average of blood glucose levels.
Time frame: From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
Incidence of Stroke-Associated Pneumonia (SAP)
Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
Time frame: Through hospital discharge (average of 9 days)
Environmental Adaptation Compliance (Intervention Group).
Measured using an Intervention Checklist. It evaluates the daily implementation of: spatial reorganization, placement of visual cues (pictograms), and accessibility of QR-coded care plans.
Time frame: Daily from hospital admission up to hospital discharge (average of 9 days).
Duration of invasive device use
Time in days from insertion until removal of invasive devices to evaluate the impact of early removal protocols. Specific measures include the duration of: venous access (peripheral catheters), nasogastric tubes, urinary catheters, and other catheterizations.
Time frame: During hospitalization (from admission to discharge).
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