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

NCT07627399 | Recruiting

• 1 other identifier: PI25/00516
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 4

Brief 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:

• 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.

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Deglutition Disorders; Perceptual Disorders; Unilateral Neglect; Pneumonia, Aspiration; Acute Stroke; Cerebrovascular Disorders

Keywords

Acute Stroke; Nursing Care; Dysphagia Screening; Unilateral Neglect; Multicomponent Intervention; Care Bundle; Stepped-Wedge Design; Deglutition; Quality of life; Hyperglycemia; Fever

Outcome Measures

Primary Outcomes (3)

• 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.

  Measured at hospital admission (baseline) and at hospital discharge (average of 9 days).

• 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.

  At hospital admission (baseline) and at hospital discharge (average of 9 days).

• 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).

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

Secondary Outcomes (7)

• Mortality

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

• Mean Systolic Blood Pressure during hospitalization.

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

• Mean Body Temperature during hospitalization.

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

• Mean Capillary Glycemia during hospitalization.

  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)

  Through hospital discharge (average of 9 days)

Other Outcomes (7)

• Sociodemographic Variables

  At hospital admission.

• Clinical Characterization

  At hospital admission.

• Length of Hospital Stay.

  Through hospital discharge (average of 9 days).

Study Arms (2)

No Intervention: usual care (control phase)

NO INTERVENTION

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: BEST CARE ICTUS_HC (intervention phase)

EXPERIMENTAL

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.

Other: BEST CARE ICTUS_HC BUNDLE

Interventions

BEST CARE ICTUS_HC BUNDLE OTHER

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.

Experimental: BEST CARE ICTUS_HC (intervention phase)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaga: lead
• Andalusian Health Service: collaborator
• Instituto de Salud Carlos III: collaborator
• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: collaborator

Study Sites (4)

Hospital de Antequera

Antequera, Málaga, 29200, Spain

NOT YET RECRUITING

Hospital Universitario Costa del Sol

Marbella, Málaga, 29603, Spain

NOT YET RECRUITING

Hospital de la Serranía de Ronda

Ronda, Málaga, 29400, Spain

NOT YET RECRUITING

Hospital Comarcal de la Axarquia

Málaga, Velez-Maálaga, 29700, Spain

RECRUITING

Related Publications (34)

• Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Pownall S, Smith CJ. Impact of Dysphagia Assessment and Management on Risk of Stroke-Associated Pneumonia: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):99-107. doi: 10.1159/000492730. Epub 2018 Sep 10.

  PMID: 30199856 BACKGROUND

• Azouvi P, Bartolomeo P, Beis JM, Perennou D, Pradat-Diehl P, Rousseaux M. A battery of tests for the quantitative assessment of unilateral neglect. Restor Neurol Neurosci. 2006;24(4-6):273-85.

  PMID: 17119304 BACKGROUND

• Perry L. Screening swallowing function of patients with acute stroke. Part two: Detailed evaluation of the tool used by nurses. J Clin Nurs. 2001 Jul;10(4):474-81. doi: 10.1046/j.1365-2702.2001.00502.x.

  PMID: 11822495 BACKGROUND

• Wolfson M, Champion H, McCoy TP, Rhodes SD, Ip EH, Blocker JN, Martin BA, Wagoner KG, O'Brien MC, Sutfin EL, Mitra A, Durant RH. Impact of a randomized campus/community trial to prevent high-risk drinking among college students. Alcohol Clin Exp Res. 2012 Oct;36(10):1767-78. doi: 10.1111/j.1530-0277.2012.01786.x. Epub 2012 Jul 23.

  PMID: 22823091 BACKGROUND

• Middleton S, Levi C, Ward J, Grimshaw J, Griffiths R, D'Este C, Dale S, Cheung NW, Quinn C, Evans M, Cadilhac D. Fever, hyperglycaemia and swallowing dysfunction management in acute stroke: a cluster randomised controlled trial of knowledge transfer. Implement Sci. 2009 Mar 16;4:16. doi: 10.1186/1748-5908-4-16.

  PMID: 19291323 BACKGROUND

• Bravata DM, Daggett VS, Woodward-Hagg H, Damush T, Plue L, Russell S, Allen G, Williams LS, Harezlak J, Chumbler NR. Comparison of two approaches to screen for dysphagia among acute ischemic stroke patients: nursing admission screening tool versus National Institutes of Health stroke scale. J Rehabil Res Dev. 2009;46(9):1127-34. doi: 10.1682/jrrd.2008.12.0169.

  PMID: 20437319 BACKGROUND

• Urimubenshi G, Langhorne P, Cadilhac DA, Kagwiza JN, Wu O. Association between patient outcomes and key performance indicators of stroke care quality: A systematic review and meta-analysis. Eur Stroke J. 2017 Dec;2(4):287-307. doi: 10.1177/2396987317735426. Epub 2017 Oct 5.

  PMID: 31008322 BACKGROUND

• Paley L, Williamson E, Bray BD, Hoffman A, James MA, Rudd AG; SSNAP Collaboration. Associations Between 30-Day Mortality, Specialist Nursing, and Daily Physician Ward Rounds in a National Stroke Registry. Stroke. 2018 Sep;49(9):2155-2162. doi: 10.1161/STROKEAHA.118.021518.

  PMID: 30354982 BACKGROUND

• Purvis T, Middleton S, Craig LE, Kilkenny MF, Dale S, Hill K, D'Este C, Cadilhac DA. Inclusion of a care bundle for fever, hyperglycaemia and swallow management in a National Audit for acute stroke: evidence of upscale and spread. Implement Sci. 2019 Sep 2;14(1):87. doi: 10.1186/s13012-019-0934-y.

  PMID: 31477125 BACKGROUND

• Middleton S, Pfeilschifter W. International translation of Fever, Sugar, Swallow Protocols: The Quality in Acute Stroke Care Europe Project. Int J Stroke. 2020 Aug;15(6):591-594. doi: 10.1177/1747493020915130. Epub 2020 Apr 16.

  PMID: 32299312 BACKGROUND

• Middleton S, Lydtin A, Comerford D, Cadilhac DA, McElduff P, Dale S, Hill K, Longworth M, Ward J, Cheung NW, D'Este C; QASCIP Working Group and Steering Committee. From QASC to QASCIP: successful Australian translational scale-up and spread of a proven intervention in acute stroke using a prospective pre-test/post-test study design. BMJ Open. 2016 May 6;6(5):e011568. doi: 10.1136/bmjopen-2016-011568.

  PMID: 27154485 BACKGROUND

• Middleton S, Coughlan K, Mnatzaganian G, Low Choy N, Dale S, Jammali-Blasi A, Levi C, Grimshaw JM, Ward J, Cadilhac DA, McElduff P, Hiller JE, D'Este C. Mortality Reduction for Fever, Hyperglycemia, and Swallowing Nurse-Initiated Stroke Intervention: QASC Trial (Quality in Acute Stroke Care) Follow-Up. Stroke. 2017 May;48(5):1331-1336. doi: 10.1161/STROKEAHA.116.016038. Epub 2017 Apr 7.

  PMID: 28389609 BACKGROUND

• Pinero Saez S, Sanz Aznarez AC, Ruiz Garcia MV, Gonzalez Garcia MJ, Mena Sucunza L, Corcoles Jimenez MP; en nombre del Grupo de Trabajo del Programa de implantacion de buenas practicas en centros comprometidos con la excelencia en cuidados(R). Implementation of the Best practice guideline: Stroke assessment across the continuum of care in hospitalised patients. Enferm Clin (Engl Ed). 2020 May-Jun;30(3):160-167. doi: 10.1016/j.enfcli.2019.10.026. Epub 2020 Apr 14. English, Spanish.

  PMID: 32303467 BACKGROUND

• Hammond L, Conroy T, Murray J. Exploring oral care practices, barriers, and facilitators in an inpatient stroke unit: a thematic analysis. Disabil Rehabil. 2023 Mar;45(5):796-804. doi: 10.1080/09638288.2022.2040616. Epub 2022 Feb 21.

  PMID: 35188869 BACKGROUND

• Baatiema L, Otim ME, Mnatzaganian G, de-Graft Aikins A, Coombes J, Somerset S. Health professionals' views on the barriers and enablers to evidence-based practice for acute stroke care: a systematic review. Implement Sci. 2017 Jun 5;12(1):74. doi: 10.1186/s13012-017-0599-3.

  PMID: 28583164 BACKGROUND

• Clare CS. Role of the nurse in acute stroke care. Nurs Stand. 2020 Apr 1;35(4):75-82. doi: 10.7748/ns.2020.e11482. Epub 2020 Mar 30.

  PMID: 32227723 BACKGROUND

• Green TL, McNair ND, Hinkle JL, Middleton S, Miller ET, Perrin S, Power M, Southerland AM, Summers DV; American Heart Association Stroke Nursing Committee of the Council on Cardiovascular and Stroke Nursing and the Stroke Council. Care of the Patient With Acute Ischemic Stroke (Posthyperacute and Prehospital Discharge): Update to 2009 Comprehensive Nursing Care Scientific Statement: A Scientific Statement From the American Heart Association. Stroke. 2021 May;52(5):e179-e197. doi: 10.1161/STR.0000000000000357. Epub 2021 Mar 11.

  PMID: 33691469 BACKGROUND

• Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.

  PMID: 32324916 BACKGROUND

• Pollock A, Hazelton C, Rowe FJ, Jonuscheit S, Kernohan A, Angilley J, Henderson CA, Langhorne P, Campbell P. Interventions for visual field defects in people with stroke. Cochrane Database Syst Rev. 2019 May 23;5(5):CD008388. doi: 10.1002/14651858.CD008388.pub3.

  PMID: 31120142 BACKGROUND

• Gillen RW, Fusco-Gessick B, Harmon EY. How We Assess Spatial Neglect Matters: Prevalence of Spatial Neglect as Measured by the Catherine Bergego Scale and Impact on Rehabilitation Outcomes. Am J Phys Med Rehabil. 2021 May 1;100(5):443-449. doi: 10.1097/PHM.0000000000001710.

  PMID: 33538488 BACKGROUND

• Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.

  PMID: 34196963 BACKGROUND

• Tucker N, Stoffel JM, Hayes L, Jones GM. Blood Pressure Management Following Acute Ischemic Stroke: A Review of Primary Literature. Crit Care Nurs Q. 2020 Apr/Jun;43(2):109-121. doi: 10.1097/CNQ.0000000000000297.

  PMID: 32084057 BACKGROUND

• Savopoulos C, Kaiafa G, Kanellos I, Fountouki A, Theofanidis D, Hatzitolios AI. Is management of hyperglycaemia in acute phase stroke still a dilemma? J Endocrinol Invest. 2017 May;40(5):457-462. doi: 10.1007/s40618-016-0584-8. Epub 2016 Nov 21.

  PMID: 27873213 BACKGROUND

• Zapata-Arriaza E, Serrano-Gotarredona P, Navarro-Herrero S, Moniche F, Pardo-Galiana B, Pallisa E, Vega-Salvatierra A, Mancha F, Escudero-Martinez I, Bustamante A, Montaner J. Chest Computed Tomography Findings and Validation of Clinical Criteria of Stroke Associated Pneumonia. J Stroke. 2019 May;21(2):217-219. doi: 10.5853/jos.2018.03251. Epub 2019 Apr 17. No abstract available.

  PMID: 30991796 BACKGROUND

• Smith CJ, Kishore AK, Vail A, Chamorro A, Garau J, Hopkins SJ, Di Napoli M, Kalra L, Langhorne P, Montaner J, Roffe C, Rudd AG, Tyrrell PJ, van de Beek D, Woodhead M, Meisel A. Diagnosis of Stroke-Associated Pneumonia: Recommendations From the Pneumonia in Stroke Consensus Group. Stroke. 2015 Aug;46(8):2335-40. doi: 10.1161/STROKEAHA.115.009617. Epub 2015 Jun 25.

  PMID: 26111886 BACKGROUND

• Eltringham SA, Kilner K, Gee M, Sage K, Bray BD, Smith CJ, Pownall S. Factors Associated with Risk of Stroke-Associated Pneumonia in Patients with Dysphagia: A Systematic Review. Dysphagia. 2020 Oct;35(5):735-744. doi: 10.1007/s00455-019-10061-6. Epub 2019 Sep 6.

  PMID: 31493069 BACKGROUND

• Burgos R, Breton I, Cereda E, Desport JC, Dziewas R, Genton L, Gomes F, Jesus P, Leischker A, Muscaritoli M, Poulia KA, Preiser JC, Van der Marck M, Wirth R, Singer P, Bischoff SC. ESPEN guideline clinical nutrition in neurology. Clin Nutr. 2018 Feb;37(1):354-396. doi: 10.1016/j.clnu.2017.09.003. Epub 2017 Sep 22.

  PMID: 29274834 BACKGROUND

• Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C; QASC Trialists Group. Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet. 2011 Nov 12;378(9804):1699-706. doi: 10.1016/S0140-6736(11)61485-2. Epub 2011 Oct 11.

  PMID: 21996470 BACKGROUND

• Pudar J, Strong B, Howard VJ, Reeves MJ. Reporting of Results by Sex in Randomized Controlled Trials of Acute Stroke Therapies (2010-2020). Stroke. 2021 Nov;52(11):e702-e705. doi: 10.1161/STROKEAHA.120.034099. Epub 2021 Sep 16.

  PMID: 34525839 BACKGROUND

• Strong B, Pudar J, Thrift AG, Howard VJ, Hussain M, Carcel C, de Los Campos G, Reeves MJ. Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke: A Meta-analysis. JAMA Neurol. 2021 Jun 1;78(6):666-677. doi: 10.1001/jamaneurol.2021.0873.

  PMID: 33900363 BACKGROUND

• Rexrode KM, Madsen TE, Yu AYX, Carcel C, Lichtman JH, Miller EC. The Impact of Sex and Gender on Stroke. Circ Res. 2022 Feb 18;130(4):512-528. doi: 10.1161/CIRCRESAHA.121.319915. Epub 2022 Feb 17.

  PMID: 35175851 BACKGROUND

• Norrving B, Barrick J, Davalos A, Dichgans M, Cordonnier C, Guekht A, Kutluk K, Mikulik R, Wardlaw J, Richard E, Nabavi D, Molina C, Bath PM, Stibrant Sunnerhagen K, Rudd A, Drummond A, Planas A, Caso V. Action Plan for Stroke in Europe 2018-2030. Eur Stroke J. 2018 Dec;3(4):309-336. doi: 10.1177/2396987318808719. Epub 2018 Oct 29.

  PMID: 31236480 BACKGROUND

• Alvarez-Sabin J, Quintana M, Masjuan J, Oliva-Moreno J, Mar J, Gonzalez-Rojas N, Becerra V, Torres C, Yebenes M; CONOCES Investigators Group. Economic impact of patients admitted to stroke units in Spain. Eur J Health Econ. 2017 May;18(4):449-458. doi: 10.1007/s10198-016-0799-9. Epub 2016 Apr 15.

  PMID: 27084749 BACKGROUND

• Ruiz Alvarez M, Aginagalde Llorente AH, Del Llano Senaris JE. [Los determinantes sociales de la salud en Espana (2010-2021): una revision exploratoria de la literatura.]. Rev Esp Salud Publica. 2022 May 12;96:e202205041. Spanish.

  PMID: 35582978 BACKGROUND

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebrovascular Disorders; Deglutition Disorders; Perceptual Disorders; Pneumonia, Aspiration; Hyperglycemia; Fever

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Temperature Changes

Study Officials

• JOSE MIGUEL MORALES-ASENCIO, PhD

  Universidad de Málaga

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JOSE MIGUEL MORALES-ASENCIO, PhD

CONTACT

+34951952833; jmmasen@uma.es

Laura Gutierrez Rodriguez, PhD

CONTACT

+34951952880; laura_gr@uma.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor / Principal Investigator

Model Details: Cluster-randomized, stepped-wedge design. The participating hospitals (clusters) are randomized to cross over from the control phase (usual care) to the intervention phase (BEST CARE ICTUS\_HC bundle) sequentially at different time points, until all clusters are eventually exposed to the intervention.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: June 4, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

ES (4)