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

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.

Overview

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.

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. 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.

Interventions

• 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, a

Primary outcome measures

• Proportion of participants with detected post-stroke dysphagia [Time frame: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).]
• Catherine Bergego Scale (CBS) score for Hemineglect [Time frame: At hospital admission (baseline) and at hospital discharge (average of 9 days).]
• Health-Related Quality of Life (HRQoL). [Time frame: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.]

Secondary outcome measures (7)

• Mortality [Time frame: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.]
• Mean Systolic Blood Pressure during hospitalization. [Time frame: From hospital admission (baseline) up to hospital discharge (average of 9 days).]
• Mean Body Temperature during hospitalization. [Time frame: From hospital admission (baseline) up to hospital discharge (average of 9 days).]
• 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)]
• Incidence of Stroke-Associated Pneumonia (SAP) [Time frame: Through hospital discharge (average of 9 days)]
• Environmental Adaptation Compliance (Intervention Group). [Time frame: Daily from hospital admission up to hospital discharge (average of 9 days).]
• Duration of invasive device use [Time frame: During hospitalization (from admission to discharge).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Health services research

Study locations

Spain · 4 centers

• Hospital de Antequera — Antequera
• Hospital Universitario Costa del Sol — Marbella
• Hospital de la Serranía de Ronda — Ronda
• Hospital Comarcal de la Axarquia — Málaga

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30354982

Identifiers

NCT: NCT07627399 · PI25/00516

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗