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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.

調査の概要

詳細な説明

#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.

研究の種類

介入

入学 (推定)

700

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:JOSE MIGUEL MORALES-ASENCIO, PhD
  • 電話番号:+34951952833
  • メール:jmmasen@uma.es

研究連絡先のバックアップ

  • 名前:Laura Gutierrez Rodriguez, PhD
  • 電話番号:+34951952880
  • メール:laura_gr@uma.es

研究場所

    • Málaga
      • Antequera、Málaga、スペイン、29200
      • Marbella、Málaga、スペイン、29603
      • Ronda、Málaga、スペイン、29400
    • Velez-Maálaga
      • Málaga、Velez-Maálaga、スペイン、29700

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:順次割り当て
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Proportion of participants with detected post-stroke dysphagia
時間枠: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
時間枠: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).
時間枠: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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Mortality
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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)
時間枠: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).
時間枠: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
時間枠: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).

その他の成果指標

結果測定
メジャーの説明
時間枠
Sociodemographic Variables
時間枠:At hospital admission.
Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
At hospital admission.
Clinical Characterization
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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).
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:JOSE MIGUEL MORALES-ASENCIO, PhD、Universidad de Málaga

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月12日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2028年12月1日

試験登録日

最初に提出

2026年2月8日

QC基準を満たした最初の提出物

2026年5月29日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月4日

QC基準を満たした最後の更新が送信されました

2026年5月29日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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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