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

29. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

#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.

Typ studie

Intervenční

Zápis (Odhadovaný)

700

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: JOSE MIGUEL MORALES-ASENCIO, PhD
  • Telefonní číslo: +34951952833
  • E-mail: jmmasen@uma.es

Studijní záloha kontaktů

  • Jméno: Laura Gutierrez Rodriguez, PhD
  • Telefonní číslo: +34951952880
  • E-mail: laura_gr@uma.es

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Výzkum zdravotnických služeb
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: 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.
Experimentální: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of participants with detected post-stroke dysphagia
Časové okno: 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
Časové okno: 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).
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mortality
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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)
Časové okno: 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).
Časové okno: 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
Časové okno: 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).

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Sociodemographic Variables
Časové okno: At hospital admission.
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
At hospital admission.
Clinical Characterization
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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).
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Malaga

Spolupracovníci

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

Vyšetřovatelé

  • Vrchní vyšetřovatel: JOSE MIGUEL MORALES-ASENCIO, PhD, Universidad de Málaga

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. května 2026

Primární dokončení (Odhadovaný)

1. prosince 2028

Dokončení studie (Odhadovaný)

1. prosince 2028

Termíny zápisu do studia

První předloženo

8. února 2026

První předloženo, které splnilo kritéria kontroly kvality

29. května 2026

První zveřejněno (Aktuální)

4. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PI25/00516

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

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