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NCT Number: NCT07627399

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

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.

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Key information

About this study

#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:

  • Educational Outreach: Intensive training for nursing staff in peripheral wards on stroke pathophysiology and the "compensatory care" model.
  • Dysphagia and Complication Prevention: Systematic use of the Modified Swallowing Assessment (MSA) to prevent aspiration and pneumonia, replacing informal clinical judgment.
  • 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.
  • Physiological Control Protocols: Algorithms for the strict monitoring of temperature, blood glucose, and blood pressure to prevent secondary brain injury.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEST CARE ICTUS_HC BUNDLE

Other

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.

Primary outcomes

  1. Proportion of participants with detected post-stroke dysphagia

    Time frame: 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.

  2. Catherine Bergego Scale (CBS) score for Hemineglect

    Time frame: 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.

  3. Health-Related Quality of Life (HRQoL).

    Time frame: 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 outcomes

  1. Mortality

    Time frame: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.

    Incidence of death from any cause in both groups.

  2. Mean Systolic Blood Pressure during hospitalization.

    Time frame: 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).

  3. Mean Body Temperature during hospitalization.

    Time frame: 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).

  4. Mean Capillary Glycemia during hospitalization.

    Time frame: 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.

  5. Incidence of Stroke-Associated Pneumonia (SAP)

    Time frame: Through hospital discharge (average of 9 days)

    Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).

  6. Environmental Adaptation Compliance (Intervention Group).

    Time frame: 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.

  7. Duration of invasive device use

    Time frame: 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.

Other outcomes

  1. Sociodemographic Variables

    Time frame: At hospital admission.

    Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.

  2. Clinical Characterization

    Time frame: At hospital admission.

    Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.

  3. Length of Hospital Stay.

    Time frame: Through hospital discharge (average of 9 days).

    Total number of days from hospital admission to discharge.

  4. All-cause hospital readmission rate at 30 days.

    Time frame: 30 days after hospital discharge.

    Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.

  5. Number of rehabilitation sessions received.

    Time frame: Up to 6 months post-discharge.

    Total count of rehabilitation sessions received by the participant.

  6. Functional Independence measured by the Barthel Index.

    Time frame: 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.

  7. Global disability measured by the Modified Rankin Scale (mRS).

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JOSE MIGUEL MORALES-ASENCIO, PhD

CONTACT

[email protected]

+34951952833

Laura Gutierrez Rodriguez, PhD

CONTACT

[email protected]

+34951952880

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Collaborators

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

Registry information

Official study title

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.

Acronym: BESTCAREICTUS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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