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

2026年5月29日 更新者:JOSE MIGUEL MORALES ASENCIO、University of Malaga

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?

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.

研究概览

详细说明

#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.

研究类型

介入性

注册 (估计的)

700

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:JOSE MIGUEL MORALES-ASENCIO, PhD
  • 电话号码:+34951952833
  • 邮箱:jmmasen@uma.es

研究联系人备份

  • 姓名:Laura Gutierrez Rodriguez, PhD
  • 电话号码:+34951952880
  • 邮箱:laura_gr@uma.es

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预: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.
实验性的: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.
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants with detected post-stroke dysphagia
大体时间:Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).

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 at hospital admission (baseline) and at hospital discharge (average of 9 days).
Catherine Bergego Scale (CBS) score for Hemineglect
大体时间:At hospital admission (baseline) and at hospital discharge (average of 9 days).
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.
At hospital admission (baseline) and at hospital discharge (average of 9 days).
Health-Related Quality of Life (HRQoL).
大体时间:At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
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).
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.

次要结果测量

结果测量
措施说明
大体时间
Mortality
大体时间:At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Incidence of death from any cause in both groups.
At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
Mean Systolic Blood Pressure during hospitalization.
大体时间:From hospital admission (baseline) up to hospital discharge (average of 9 days).
Average of systolic blood pressure readings recorded to assess physiological stability. Unit of measurement: millimeters of mercury (mmHg).
From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Body Temperature during hospitalization.
大体时间:From hospital admission (baseline) up to hospital discharge (average of 9 days).
Average of body temperature readings measured daily. Unit of measurement: degrees Celsius (°C).
From hospital admission (baseline) up to hospital discharge (average of 9 days).
Mean Capillary Glycemia during hospitalization.
大体时间:From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
Average of blood glucose levels.
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)
大体时间:Through hospital discharge (average of 9 days)
Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
Through hospital discharge (average of 9 days)
Environmental Adaptation Compliance (Intervention Group).
大体时间:Daily from hospital admission up to hospital discharge (average of 9 days).
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.
Daily from hospital admission up to hospital discharge (average of 9 days).
Duration of invasive device use
大体时间:During hospitalization (from admission to discharge).
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.
During hospitalization (from admission to discharge).

其他结果措施

结果测量
措施说明
大体时间
Sociodemographic Variables
大体时间:At hospital admission.
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
At hospital admission.
Clinical Characterization
大体时间:At hospital admission.
Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.
At hospital admission.
Length of Hospital Stay.
大体时间:Through hospital discharge (average of 9 days).
Total number of days from hospital admission to discharge.
Through hospital discharge (average of 9 days).
All-cause hospital readmission rate at 30 days.
大体时间:30 days after hospital discharge.
Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.
30 days after hospital discharge.
Number of rehabilitation sessions received.
大体时间:Up to 6 months post-discharge.
Total count of rehabilitation sessions received by the participant.
Up to 6 months post-discharge.
Functional Independence measured by the Barthel Index.
大体时间:At hospital admission (baseline) and at hospital discharge (average of 9 days)
Assessed using the Barthel Index (activities of daily living) and the Modified Rankin Scale (mRS) (global disability) in both groups.
At hospital admission (baseline) and at hospital discharge (average of 9 days)
Global disability measured by the Modified Rankin Scale (mRS).
大体时间:At hospital admission (baseline) and at hospital discharge (average of 9 days).
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.
At hospital admission (baseline) and at hospital discharge (average of 9 days).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:JOSE MIGUEL MORALES-ASENCIO, PhD、Universidad de Málaga

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月12日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年2月8日

首先提交符合 QC 标准的

2026年5月29日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

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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研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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