An interventional study of BEST CARE ICTUS_HC BUNDLE in Stroke, Acute Stroke and Ischemic Stroke, sponsored by University of Malaga. Recruiting at 4 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by University of Malaga · Not applicable, Interventional, and Health services research
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:
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:
#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:
The "FLECHA" Project (Environmental Adaptation and Compensatory Care):
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 700 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Malaga is the lead sponsor of 121 studies on the registry; 34 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Other: 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.
Proportion 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).
Sociodemographic Variables
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
Time frame: At hospital admission.
Clinical Characterization
Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.
Time frame: At hospital admission.
Length of Hospital Stay.
Total number of days from hospital admission to discharge.
Time frame: Through hospital discharge (average of 9 days).
All-cause hospital readmission rate at 30 days.
Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.
Time frame: 30 days after hospital discharge.
Number of rehabilitation sessions received.
Total count of rehabilitation sessions received by the participant.
Time frame: Up to 6 months post-discharge.
Functional Independence measured by the Barthel Index.
Assessed using the Barthel Index (activities of daily living) and the Modified Rankin Scale (mRS) (global disability) in both groups.
Time frame: At hospital admission (baseline) and at hospital discharge (average of 9 days)
Global disability measured by the Modified Rankin Scale (mRS).
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.
Time frame: At hospital admission (baseline) and at hospital discharge (average of 9 days).
Plan to share: Undecided — 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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