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Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC)

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.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07627399
Acronym
BESTCAREICTUS
Enrollment
700
Registered
2026-06-04
Start date
2026-05-12
Completion date
2028-12-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke, Cerebrovascular Disorders, Deglutition Disorders, Hemorrhagic Stroke, Ischemic Stroke, Perceptual Disorders, Pneumonia, Aspiration, Stroke, Unilateral Neglect

Keywords

Acute Stroke, Nursing Care, Dysphagia Screening, Unilateral Neglect, Multicomponent Intervention, Care Bundle, Stepped-Wedge Design, Deglutition, Quality of life, Hyperglycemia, Fever

Brief summary

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.

Detailed description

#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.

Interventions

OTHERBEST CARE ICTUS_HC BUNDLE

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.

Sponsors

University of Malaga
Lead SponsorOTHER
Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
CollaboratorOTHER
Andalusian Health Service
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Cluster-randomized, stepped-wedge design. The participating hospitals (clusters) are randomized to cross over from the control phase (usual care) to the intervention phase (BEST CARE ICTUS\_HC bundle) sequentially at different time points, until all clusters are eventually exposed to the intervention.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of participants with detected post-stroke dysphagiaMeasured at hospital admission (baseline) and at hospital discharge (average of 9 days).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.
Catherine Bergego Scale (CBS) score for HemineglectAt hospital admission (baseline) and at hospital discharge (average of 9 days).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.
Health-Related Quality of Life (HRQoL).At hospital discharge, 30 days post-discharge, and 6 months post-discharge.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).

Secondary

MeasureTime frameDescription
MortalityAt hospital discharge, 30 days post-discharge, and 6 months post-discharge.Incidence of death from any cause in both groups.
Mean Systolic Blood Pressure during hospitalization.From hospital admission (baseline) up to hospital discharge (average of 9 days).Average of systolic blood pressure readings recorded to assess physiological stability. Unit of measurement: millimeters of mercury (mmHg).
Mean Body Temperature during hospitalization.From hospital admission (baseline) up to hospital discharge (average of 9 days).Average of body temperature readings measured daily. Unit of measurement: degrees Celsius (°C).
Mean Capillary Glycemia during hospitalization.From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)Average of blood glucose levels.
Incidence of Stroke-Associated Pneumonia (SAP)Through hospital discharge (average of 9 days)Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
Environmental Adaptation Compliance (Intervention Group).Daily from hospital admission up to hospital discharge (average of 9 days).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.
Duration of invasive device useDuring hospitalization (from admission to discharge).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.

Countries

Spain

Contacts

CONTACTJOSE MIGUEL MORALES-ASENCIO, PhD
jmmasen@uma.es+34951952833
CONTACTLaura Gutierrez Rodriguez, PhD
laura_gr@uma.es+34951952880
PRINCIPAL_INVESTIGATORJOSE MIGUEL MORALES-ASENCIO, PhD

Universidad de Málaga

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026