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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.

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital de Antequera
NOT_YET_RECRUITING
Antequera
Hospital Comarcal de la Axarquia
RECRUITING
Málaga
Hospital Universitario Costa del Sol
NOT_YET_RECRUITING
Marbella
Hospital de la Serranía de Ronda
NOT_YET_RECRUITING
Ronda
Contact Information
Primary
JOSE MIGUEL MORALES-ASENCIO, PhD
jmmasen@uma.es
+34951952833
Backup
Laura Gutierrez Rodriguez, PhD
laura_gr@uma.es
+34951952880
Time Frame
Start Date: 2026-05-12
Estimated Completion Date: 2028-12
Participants
Target number of participants: 700
Treatments
No_intervention: 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.
Experimental: 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.
Sponsors
Collaborators: Andalusian Health Service, Instituto de Salud Carlos III, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Leads: University of Malaga

This content was sourced from clinicaltrials.gov