Effectiveness of Best Care Practices in Acute Stroke in Conventional Hospitalization (BEST CARE ICTUS_HC) (BESTCAREICTUS)
2026년 5월 29일 업데이트: 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:
- Does the implementation of the program increase the early and correct detection of swallowing difficulties (dysphagia) to prevent pneumonia?
- 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
#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:
- Educational Outreach: Intensive training for nursing staff in peripheral wards on stroke pathophysiology and the "compensatory care" model.
- Dysphagia and Complication Prevention: Systematic use of the Modified Swallowing Assessment (MSA) to prevent aspiration and pneumonia, replacing informal clinical judgment.
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.
- Physiological Control Protocols: Algorithms for the strict monitoring of temperature, blood glucose, and blood pressure to prevent secondary brain injury.
- 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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
700
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: JOSE MIGUEL MORALES-ASENCIO, PhD
- 전화번호: +34951952833
- 이메일: jmmasen@uma.es
연구 연락처 백업
- 이름: Laura Gutierrez Rodriguez, PhD
- 전화번호: +34951952880
- 이메일: laura_gr@uma.es
연구 장소
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Málaga
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Antequera, Málaga, 스페인, 29200
- 아직 모집하지 않음
- Hospital de Antequera
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연락하다:
- María Socorro Zurita, Nurse
- 전화번호: 951 06 16 00
- 이메일: socorro.zurita.sspa@juntadeandalucia.es
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Marbella, Málaga, 스페인, 29603
- 아직 모집하지 않음
- Hospital Universitario Costa del Sol
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연락하다:
- Leticia García, Nurse
- 전화번호: 951 97 66 69
- 이메일: marialeticia.garcia.d.sspa@juntadeandalucia.es
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Ronda, Málaga, 스페인, 29400
- 아직 모집하지 않음
- Hospital de la Serranía de Ronda
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연락하다:
- Ángeles Gordillo, Nurse
- 전화번호: 951 06 50 00
- 이메일: angeles.gordillo.sspa@juntadeandalucia.es
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Velez-Maálaga
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Málaga, Velez-Maálaga, 스페인, 29700
- 모병
- Hospital Comarcal de la Axarquía
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연락하다:
- Carmen Lupiañez Bueno, Nurse
- 전화번호: +34 951 06 70 00
- 이메일: mc.lupianez.sspa@juntadeandalucia.es
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: 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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with detected post-stroke dysphagia
기간: Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).
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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).
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Catherine Bergego Scale (CBS) score for Hemineglect
기간: At hospital admission (baseline) and at hospital discharge (average of 9 days).
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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.
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At hospital admission (baseline) and at hospital discharge (average of 9 days).
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Health-Related Quality of Life (HRQoL).
기간: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
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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).
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At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mortality
기간: At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
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Incidence of death from any cause in both groups.
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At hospital discharge, 30 days post-discharge, and 6 months post-discharge.
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Mean Systolic Blood Pressure during hospitalization.
기간: From hospital admission (baseline) up to hospital discharge (average of 9 days).
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Average of systolic blood pressure readings recorded to assess physiological stability.
Unit of measurement: millimeters of mercury (mmHg).
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From hospital admission (baseline) up to hospital discharge (average of 9 days).
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Mean Body Temperature during hospitalization.
기간: From hospital admission (baseline) up to hospital discharge (average of 9 days).
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Average of body temperature readings measured daily.
Unit of measurement: degrees Celsius (°C).
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From hospital admission (baseline) up to hospital discharge (average of 9 days).
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Mean Capillary Glycemia during hospitalization.
기간: From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
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Average of blood glucose levels.
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From hospital admission (baseline) up to hospital discharge (average of 9 days). Unit of measurement: milligrams per deciliter (mg/dL)
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Incidence of Stroke-Associated Pneumonia (SAP)
기간: Through hospital discharge (average of 9 days)
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Number of participants who develop pneumonia according to the PISCES criteria (Pneumonia in Stroke Consensus).
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Through hospital discharge (average of 9 days)
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Environmental Adaptation Compliance (Intervention Group).
기간: Daily from hospital admission up to hospital discharge (average of 9 days).
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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.
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Daily from hospital admission up to hospital discharge (average of 9 days).
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Duration of invasive device use
기간: During hospitalization (from admission to discharge).
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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.
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During hospitalization (from admission to discharge).
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sociodemographic Variables
기간: At hospital admission.
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Registration of sex, age, educational level, main caregiver availability and main caregiver's sex.
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At hospital admission.
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Clinical Characterization
기간: At hospital admission.
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Assessment of comorbidities (Charlson Comorbidity Index), type of stroke (ischemic/hemorrhagic), affected side, and prescribed treatments.
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At hospital admission.
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Length of Hospital Stay.
기간: Through hospital discharge (average of 9 days).
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Total number of days from hospital admission to discharge.
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Through hospital discharge (average of 9 days).
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All-cause hospital readmission rate at 30 days.
기간: 30 days after hospital discharge.
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Proportion of participants readmitted to the hospital for any cause within 30 days after discharge.
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30 days after hospital discharge.
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Number of rehabilitation sessions received.
기간: Up to 6 months post-discharge.
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Total count of rehabilitation sessions received by the participant.
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Up to 6 months post-discharge.
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Functional Independence measured by the Barthel Index.
기간: At hospital admission (baseline) and at hospital discharge (average of 9 days)
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Assessed using the Barthel Index (activities of daily living) and the Modified Rankin Scale (mRS) (global disability) in both groups.
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At hospital admission (baseline) and at hospital discharge (average of 9 days)
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Global disability measured by the Modified Rankin Scale (mRS).
기간: At hospital admission (baseline) and at hospital discharge (average of 9 days).
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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.
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At hospital admission (baseline) and at hospital discharge (average of 9 days).
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: JOSE MIGUEL MORALES-ASENCIO, PhD, Universidad de Málaga
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 5월 12일
기본 완료 (추정된)
기본 완료
2028년 12월 1일
연구 완료 (추정된)
연구 완료
2028년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 2월 8일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 5월 29일
처음 게시됨 (실제)
처음 게시됨
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 29일
마지막으로 확인됨
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- PI25/00516
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
미정
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .