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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Malaga

About this 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?

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BEST CARE ICTUS_HC BUNDLE

    Other intervention

    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.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: No Intervention: usual care (control phase)No intervention 0 interventions
Group B: Experimental: BEST CARE ICTUS_HC (intervention phase)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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).

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

Secondary outcomes

1

Mortality

Incidence of death from any cause in both groups.

Time frame
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).

Time frame
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).

Time frame
From hospital admission (baseline) up to hospital discharge (average of 9 days).
4

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)

Other outcomes

1

Sociodemographic Variables

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

Time frame
At hospital admission.
2

Clinical Characterization

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

Time frame
At hospital admission.
3

Length of Hospital Stay.

Total number of days from hospital admission to discharge.

Time frame
Through hospital discharge (average of 9 days).
4

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.

Sponsors and contacts

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University of Malaga

Lead sponsor

Instituto de Salud Carlos III

Collaborator

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Collaborator

Andalusian Health Service

Collaborator