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

29 mai 2026 mis à jour par: JOSE MIGUEL MORALES ASENCIO, University of Malaga

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.

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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

#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.

Type d'étude

Interventionnel

Inscription (Estimé)

700

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: JOSE MIGUEL MORALES-ASENCIO, PhD
  • Numéro de téléphone: +34951952833
  • E-mail: jmmasen@uma.es

Sauvegarde des contacts de l'étude

  • Nom: Laura Gutierrez Rodriguez, PhD
  • Numéro de téléphone: +34951952880
  • E-mail: laura_gr@uma.es

Lieux d'étude

  • Espagne
    • Málaga
      • Antequera, Málaga, Espagne, 29200
      • Marbella, Málaga, Espagne, 29603
      • Ronda, Málaga, Espagne, 29400
    • Velez-Maálaga
      • Málaga, Velez-Maálaga, Espagne, 29700

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: No Intervention: usual care (control phase)
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.
Expérimental: Experimental: BEST CARE ICTUS_HC (intervention phase)
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.
Autre: BEST 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of participants with detected post-stroke dysphagia
Délai: Measured 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.
Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).
Catherine Bergego Scale (CBS) score for Hemineglect
Délai: At 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.
At hospital admission (baseline) and at hospital discharge (average of 9 days).
Health-Related Quality of Life (HRQoL).
Délai: 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).
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mortality
Délai: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Incidence of death from any cause in both groups.
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Mean Systolic Blood Pressure during hospitalization.
Délai: 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).
From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Body Temperature during hospitalization.
Délai: 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).
From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Capillary Glycemia during hospitalization.
Délai: 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.
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)
Délai: Through hospital discharge (average of 9 days)
Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
Through hospital discharge (average of 9 days)
Environmental Adaptation Compliance (Intervention Group).
Délai: 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.
Daily from hospital admission up to hospital discharge (average of 9 days).
Duration of invasive device use
Délai: During 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.
During hospitalization (from admission to discharge).

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Sociodemographic Variables
Délai: At hospital admission.
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
At hospital admission.
Clinical Characterization
Délai: At hospital admission.
Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.
At hospital admission.
Length of Hospital Stay.
Délai: Through hospital discharge (average of 9 days).
Total number of days from hospital admission to discharge.
Through hospital discharge (average of 9 days).
All-cause hospital readmission rate at 30 days.
Délai: 30 days after hospital discharge.
Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.
30 days after hospital discharge.
Number of rehabilitation sessions received.
Délai: Up to 6 months post-discharge.
Total count of rehabilitation sessions received by the participant.
Up to 6 months post-discharge.
Functional Independence measured by the Barthel Index.
Délai: At hospital admission (baseline) and at hospital discharge (average of 9 days)
Assessed using the Barthel Index (activities of daily living) and the Modified Rankin Scale (mRS) (global disability) in both groups.
At hospital admission (baseline) and at hospital discharge (average of 9 days)
Global disability measured by the Modified Rankin Scale (mRS).
Délai: At hospital admission (baseline) and at hospital discharge (average of 9 days).
The mRS is a scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). Higher scores indicate greater disability.
At hospital admission (baseline) and at hospital discharge (average of 9 days).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Malaga

Collaborateurs

Instituto de Salud Carlos III
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Andalusian Health Service

Les enquêteurs

  • Chercheur principal: JOSE MIGUEL MORALES-ASENCIO, PhD, Universidad de Málaga

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 mai 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

8 février 2026

Première soumission répondant aux critères de contrôle qualité

29 mai 2026

Première publication (Réel)

4 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PI25/00516

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Description du régime IPD

The decision to share individual participant data has not yet been determined. The study involves sensitive, coded clinical data, with access restricted to the research team.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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