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StrokeBESTCAREICTUSNCT07627399

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

A study testing BEST CARE ICTUS_HC BUNDLE in people with Stroke and Acute Stroke, run by University of Malaga at 4 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Acute Stroke, Ischemic Stroke
What is being tested?
BEST CARE ICTUS_HC BUNDLE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
4 sitesSpain
Study dates
12 May 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

JOSE MIGUEL MORALES-ASENCIO, PhD contact

+34951952833

jmmasen@uma.es

Laura Gutierrez Rodriguez, PhD contact

+34951952880

laura_gr@uma.es

Spain4 sites, 4 recruiting

  • Hospital de Antequera

    Antequera, Málaga, 29200

    María Socorro Zurita, Nurse, 951 06 16 00, socorro.zurita.sspa@juntadeandalucia.es

    Not yet recruiting

  • Hospital Comarcal de la Axarquia

    Málaga, Velez-Maálaga, 29700

    Carmen Lupiañez Bueno, Nurse, +34 951 06 70 00, mc.lupianez.sspa@juntadeandalucia.es

    Recruiting

  • Hospital Universitario Costa del Sol

    Marbella, Málaga, 29603

    Leticia García, Nurse, 951 97 66 69, marialeticia.garcia.d.sspa@juntadeandalucia.es

    Not yet recruiting

  • Hospital de la Serranía de Ronda

    Ronda, Málaga, 29400

    Ángeles Gordillo, Nurse, 951 06 50 00, angeles.gordillo.sspa@juntadeandalucia.es

    Not yet recruiting

Other trials in Spain

About this study

Official 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.

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?
Read more

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.
Read the 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.
  1. Physiological Control Protocols: Algorithms for the strict monitoring of temperature, blood glucose, and blood pressure to prevent secondary brain injury.
  2. 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.

Being tested
BEST CARE ICTUS_HC BUNDLE
Keywords
Acute Stroke, Nursing Care, Dysphagia Screening, Unilateral Neglect, Multicomponent Intervention, Care Bundle, Stepped-Wedge Design, Deglutition, Quality of life, Hyperglycemia, Fever
Medical subject headings
Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular Disorders, Deglutition Disorders, Perceptual Disorders, Pneumonia, Aspiration, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BEST CARE ICTUS_HC BUNDLEOther

    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.

Study groups in NCT07627399
Study groupRoleWhat they receive
No Intervention: usual care (control phase)No interventionPatients 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.
Experimental: BEST CARE ICTUS_HC (intervention phase)Experimental1) 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.
Receives: Other: BEST CARE ICTUS_HC BUNDLE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).

  2. 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.

    Measured: At hospital admission (baseline) and at hospital discharge (average of 9 days).

  3. 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).

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

Secondary outcomes (7)

  1. Mortality

    Incidence of death from any cause in both groups.

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

  2. Mean Systolic Blood Pressure during hospitalization.

    Average of systolic blood pressure readings recorded to assess physiological stability. Unit of measurement: millimeters of mercury (mmHg).

    Measured: From hospital admission (baseline) up to hospital discharge (average of 9 days).

  3. Mean Body Temperature during hospitalization.

    Average of body temperature readings measured daily. Unit of measurement: degrees Celsius (°C).

    Measured: From hospital admission (baseline) up to hospital discharge (average of 9 days).

  4. Mean Capillary Glycemia during hospitalization.

    Average of blood glucose levels.

    Measured: From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)

  5. Incidence of Stroke-Associated Pneumonia (SAP)

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

    Measured: Through hospital discharge (average of 9 days)

  6. 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.

    Measured: Daily from hospital admission up to hospital discharge (average of 9 days).

  7. 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.

    Measured: During hospitalization (from admission to discharge).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start12 May 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627399
Sponsor's protocol ID
PI25/00516
Acronym
BESTCAREICTUS
Status last verified
May 2026
First submitted
8 Feb 2026
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.

    PubMed 30199856

  • Azouvi P, Bartolomeo P, Beis JM, Perennou D, Pradat-Diehl P, Rousseaux M. A battery of tests for the quantitative assessment of unilateral neglect. Restor Neurol Neurosci. 2006;24(4-6):273-85.

    PubMed 17119304

  • Perry L. Screening swallowing function of patients with acute stroke. Part two: Detailed evaluation of the tool used by nurses. J Clin Nurs. 2001 Jul;10(4):474-81. doi: 10.1046/j.1365-2702.2001.00502.x.

    PubMed 11822495

  • Wolfson M, Champion H, McCoy TP, Rhodes SD, Ip EH, Blocker JN, Martin BA, Wagoner KG, O'Brien MC, Sutfin EL, Mitra A, Durant RH. Impact of a randomized campus/community trial to prevent high-risk drinking among college students. Alcohol Clin Exp Res. 2012 Oct;36(10):1767-78. doi: 10.1111/j.1530-0277.2012.01786.x. Epub 2012 Jul 23.

    PubMed 22823091

  • Middleton S, Levi C, Ward J, Grimshaw J, Griffiths R, D'Este C, Dale S, Cheung NW, Quinn C, Evans M, Cadilhac D. Fever, hyperglycaemia and swallowing dysfunction management in acute stroke: a cluster randomised controlled trial of knowledge transfer. Implement Sci. 2009 Mar 16;4:16. doi: 10.1186/1748-5908-4-16.

    PubMed 19291323

  • Bravata DM, Daggett VS, Woodward-Hagg H, Damush T, Plue L, Russell S, Allen G, Williams LS, Harezlak J, Chumbler NR. Comparison of two approaches to screen for dysphagia among acute ischemic stroke patients: nursing admission screening tool versus National Institutes of Health stroke scale. J Rehabil Res Dev. 2009;46(9):1127-34. doi: 10.1682/jrrd.2008.12.0169.

    PubMed 20437319

  • Urimubenshi G, Langhorne P, Cadilhac DA, Kagwiza JN, Wu O. Association between patient outcomes and key performance indicators of stroke care quality: A systematic review and meta-analysis. Eur Stroke J. 2017 Dec;2(4):287-307. doi: 10.1177/2396987317735426. Epub 2017 Oct 5.

    PubMed 31008322

  • Paley L, Williamson E, Bray BD, Hoffman A, James MA, Rudd AG; SSNAP Collaboration. Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry. Stroke. 2018 Sep;49(9):2155-2162. doi: 10.1161/STROKEAHA.118.021518.

    PubMed 30354982

  • Purvis T, Middleton S, Craig LE, Kilkenny MF, Dale S, Hill K, D'Este C, Cadilhac DA. Inclusion of a care bundle for fever, hyperglycaemia and swallow management in a National Audit for acute stroke: evidence of upscale and spread. Implement Sci. 2019 Sep 2;14(1):87. doi: 10.1186/s13012-019-0934-y.

    PubMed 31477125

  • Middleton S, Pfeilschifter W. International translation of Fever, Sugar, Swallow Protocols: The Quality in Acute Stroke Care Europe Project. Int J Stroke. 2020 Aug;15(6):591-594. doi: 10.1177/1747493020915130. Epub 2020 Apr 16.

    PubMed 32299312

  • Middleton S, Lydtin A, Comerford D, Cadilhac DA, McElduff P, Dale S, Hill K, Longworth M, Ward J, Cheung NW, D'Este C; QASCIP Working Group and Steering Committee. From QASC to QASCIP: successful Australian translational scale-up and spread of a proven intervention in acute stroke using a prospective pre-test/post-test study design. BMJ Open. 2016 May 6;6(5):e011568. doi: 10.1136/bmjopen-2016-011568.

    PubMed 27154485

  • Middleton S, Coughlan K, Mnatzaganian G, Low Choy N, Dale S, Jammali-Blasi A, Levi C, Grimshaw JM, Ward J, Cadilhac DA, McElduff P, Hiller JE, D'Este C. Mortality Reduction for Fever, Hyperglycemia, and Swallowing Nurse-Initiated Stroke Intervention: QASC Trial (Quality in Acute Stroke Care) Follow-Up. Stroke. 2017 May;48(5):1331-1336. doi: 10.1161/STROKEAHA.116.016038. Epub 2017 Apr 7.

    PubMed 28389609

  • Pinero Saez S, Sanz Aznarez AC, Ruiz Garcia MV, Gonzalez Garcia MJ, Mena Sucunza L, Corcoles Jimenez MP; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en centros comprometidos con la excelencia en cuidados(R). Implementation of the Best practice guideline: Stroke assessment across the continuum of care in hospitalised patients. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):160-167. doi: 10.1016/j.enfcli.2019.10.026. Epub 2020 Apr 14. English, Spanish.

    PubMed 32303467

  • Hammond L, Conroy T, Murray J. Exploring oral care practices, barriers, and facilitators in an inpatient stroke unit: a thematic analysis. Disabil Rehabil. 2023 Mar;45(5):796-804. doi: 10.1080/09638288.2022.2040616. Epub 2022 Feb 21.

    PubMed 35188869

  • Baatiema L, Otim ME, Mnatzaganian G, de-Graft Aikins A, Coombes J, Somerset S. Health professionals' views on the barriers and enablers to evidence-based practice for acute stroke care: a systematic review. Implement Sci. 2017 Jun 5;12(1):74. doi: 10.1186/s13012-017-0599-3.

    PubMed 28583164

Questions about this trial

What is this clinical trial studying?

A study testing BEST CARE ICTUS_HC BUNDLE in people with Stroke and Acute Stroke, run by University of Malaga at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JOSE MIGUEL MORALES-ASENCIO, PhD (+34951952833, jmmasen@uma.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with detected post-stroke dysphagia (time frame: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07627399, which also lists 34 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

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