Non-pharmacological Measures for the Prevention of Delirium in Frail Hospitalized Adults. Nursing Care (PREDELENF)

NCT07119385 | Completed

• 1 other identifier: PI-23-105
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Delirium is one of the most frequent, relevant, and increasing geriatric syndromes in hospitalized older adults. It is an indicator of poor prognosis, and its incidence increases with aging. It is a highly prevalent problem (between 10-56% of hospitalized elderly), underdiagnosed (32-66% undetected), with severe consequences and potentially preventable (between 30-40%). It is considered a priority health objective, as it is an indicator of elderly patient safety and an indicator of healthcare quality. Objective: The objective of this study is to analyze whether a multicomponent nursing-led intervention reduces the incidence of delirium in frail older patients hospitalized in a medical unit. Design: Pre-post quasi-experimental analytical study. Study setting: The study will be conducted in a polyvalent hospitalization unit at the Germans Trias i Pujol University Hospital during the 2023-2025 period. Patients: A total of 158 patients will be needed, i.e., 79 for each group. Sampling: Consecutive intentional sampling based on inclusion and exclusion criteria. Variables: Sociodemographic variables, delirium risk factors, daily presence of delirium using the CAM scale, and hospital stay duration, among others, will be collected. Procedure: Patients will be selected upon admission, and the presence of delirium will be assessed daily using the CAM scale, with results recorded. Nursing staff will be trained on non-pharmacological measures for delirium prevention and a specific care plan. Subsequently, the second group of patients will receive these specific interventions, and the presence of delirium will be assessed daily using the CAM scale, with results recorded. Data analysis: Descriptive and inferential analysis using the PSPP statistical package version 22. A significance level of 5% will be applied.

Conditions

Delirium in Old Age

Keywords

Prevention; Delirium; Frailty; Multicomponent intervention

Outcome Measures

Primary Outcomes (1)

• Presence of Delirium

  Assessment of the presence of delirium will be performed by trained personnel using the Confusion Assessment Method (CAM). The CAM consists of four items, and a positive CAM (indicating the presence of delirium) is defined as the presence of both of the first two items (1 and 2) and at least one of the last two items (3 or 4).

  From baseline (day 1) until day 12 (expected date of hospital discharge or death from any cause)

Secondary Outcomes (4)

• Sociodemographic Variables

  Baseline

• Current illness/geriatric assessment upon admission. Assess cognition using the Pfeiffer Questionnaire

  Baseline

• Current illness/geriatric assessment upon admission. Diagnosis of Dementia

  Baseline

• Current illness/geriatric assessment upon admission. Degree of frailty

  Baseline

Study Arms (2)

No intervention (usual medical care)

OTHER

The usual care will be provided according to the center's protocols.

Other: Usual care

Intervention (PREDELENF Multicomponent Intervention)

EXPERIMENTAL

A multicomponent intervention designed for the prevention of delirium in frail patients.Include different actions (see variables)

Other: Multicomponent non-pharmacological interventions

Interventions

Multicomponent non-pharmacological interventions OTHER

Multicomponent non-pharmacological interventions to prevent delirium in frail patients

Intervention (PREDELENF Multicomponent Intervention)

Usual care OTHER

Usual care

No intervention (usual medical care)

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients \>70 years old
• Conscious mental state. And one of the two criteria described below:
• Pfeiffer score on admission between 3-7 errors, according to the nursing assessment within the first 24 hours of admission to the ward, suggesting possible mild-moderate cognitive impairment.
• Any degree of diagnosed dementia, except GDS7.

You may not qualify if:

• Patients unable to communicate, with established aphasia, or with psychiatric illness.
• Patients with a language barrier.
• Patients transferred from other units.
• Terminal situation under palliative treatment.
• Patients who do not consent to participate

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Germans Trias i Pujol Hospital

Badalona, Catalonia, 08916, Spain

Location

Related Publications (26)

• Tobar E, Alvarez E. Delirium en el adulto mayor hospitalizado. RMCLC. 2020;

  BACKGROUND

• Chavez-Delgado ME, Virgen-Enciso M, Perez-Guzman J, Celis-de-la-Rosa A, Castro-Castaneda S. [Detection of delirium in hospitalized elderly patients using the confusion assessment method]. Rev Med Inst Mex Seguro Soc. 2007 Jul-Aug;45(4):321-8. Spanish.

  PMID: 17949569 BACKGROUND

• Cano G. Contribuciones al estudio de factores de riesgo y mortalidad del delirium y fragilidad en adultos mayores hospitalizados. Bilbao. 2022.

  BACKGROUND

• Fernandez Mª, Faus M. Medidas no farmacológicas para la prevención del delirium en pacientes ingresados en Unidades de Cuidados Intensivos. THERAPEÍA. 2021;14: 113-40.

  BACKGROUND

• Gonzalez B, Marín JM, Gutierrez V, Velilla N. Protocolo diagnóstico y manejo del delirium en el anciano. Protocolos. 2018;12(62): 3670-4.

  BACKGROUND

• Carrasco G M, Villarroel D L, Calderon P J, Martinez F G, Andrade A M, Gonzalez T M. [Development and validation of a clinical predictive model for delirium in hospitalized older people]. Rev Med Chil. 2014 Jul;142(7):826-32. doi: 10.4067/S0034-98872014000700002. Spanish.

  PMID: 25378001 BACKGROUND

• Restrepo D, Duque M, Montoya L, Berrouet MC, Rojas M, Lopera G, Giraldo K. Risk Factors and Hospital Mortality in Surgical and Non-surgical Patients with Delirium. Rev Colomb Psiquiatr (Engl Ed). 2018 Jul-Sep;47(3):148-154. doi: 10.1016/j.rcp.2017.03.001. Epub 2017 Apr 21. English, Spanish.

  PMID: 30017037 BACKGROUND

• Witlox J, Eurelings LS, de Jonghe JF, Kalisvaart KJ, Eikelenboom P, van Gool WA. Delirium in elderly patients and the risk of postdischarge mortality, institutionalization, and dementia: a meta-analysis. JAMA. 2010 Jul 28;304(4):443-51. doi: 10.1001/jama.2010.1013.

  PMID: 20664045 BACKGROUND

• Bellelli G, Brathwaite JS, Mazzola P. Delirium: A Marker of Vulnerability in Older People. Front Aging Neurosci. 2021 Apr 30;13:626127. doi: 10.3389/fnagi.2021.626127. eCollection 2021.

  PMID: 33994990 BACKGROUND

• Leslie DL, Marcantonio ER, Zhang Y, Leo-Summers L, Inouye SK. One-year health care costs associated with delirium in the elderly population. Arch Intern Med. 2008 Jan 14;168(1):27-32. doi: 10.1001/archinternmed.2007.4.

  PMID: 18195192 BACKGROUND

• Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.

  PMID: 23992774 BACKGROUND

• Carrasco M, Accatino-Scagliotti L, Calderon J, Villarroel L, Marin PP, Gonzalez M. [Delirium in older medical inpatients: a one year follow up study]. Rev Med Chil. 2012 Jul;140(7):847-52. doi: 10.4067/S0034-98872012000700003. Spanish.

  PMID: 23282695 BACKGROUND

• Formiga F, San Jose A, Lopez-Soto A, Ruiz D, Urrutia A, Duaso E. [Prevalence of delirium in patients admitted because of medical conditions]. Med Clin (Barc). 2007 Oct 27;129(15):571-3. doi: 10.1157/13111707. Spanish.

  PMID: 17988613 BACKGROUND

• Pão-Mole M, Dourado RM, Pontífice P. Delirium: intervenciones de enfermería en el adulto hospitalizado - una revisión bibliográfica. Enferm glob. 2018;17(52): 640-88.

  BACKGROUND

• Perello Campaner C. [Delirium risk assessment in elderly hospitalized patients]. Rev Esp Geriatr Gerontol. 2010 Sep-Oct;45(5):285-90. doi: 10.1016/j.regg.2010.03.011. Epub 2010 Aug 8. Spanish.

  PMID: 20696498 BACKGROUND

• Avendaño A. Ensayo clínico piloto de una intervención multicomponente de enfermería para reducir el delirium en ancianos hospitalizados. (MID-Nurse-P). Albacete. 2019

  BACKGROUND

• Ramón JL, Gallardo M. Delirium o síndrome confusional agudo. AMF. 2015;11(9): 516-23

  BACKGROUND

• Giraldo CC, Pérez JM, Sánchez DM. Terapia Física Temprana para la Prevención del Delirio en la Unidad de Cuidados Intensivos. Arch de Medicina. 2021;17(5): 1

  BACKGROUND

• Carrera C, Romero FJ, González A. Revisión de la utilidad y fiabilidad de la Confusion Assessment Method en atención especializada y primaria, 2013. Av Enferm. 2015;33(2): 261-70.

  BACKGROUND

• Miranda F, Gonzalez F, Plana MN, Zamora J, Quinn TJ, Seron P. Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) for the diagnosis of delirium in adults in critical care settings. Cochrane Database Syst Rev. 2023 Nov 21;11(11):CD013126. doi: 10.1002/14651858.CD013126.pub2.

  PMID: 37987526 BACKGROUND

• Palihnich K, Gallagher, J, Inouye SK, Marcantonio ER. The 3D CAM Training Manual for Research. V4.1. 2016; Boston: Hospital Elder Life Program.

  BACKGROUND

• Avendano-Cespedes A, Garcia-Cantos N, Gonzalez-Teruel Mdel M, Martinez-Garcia M, Villarreal-Bocanegra E, Oliver-Carbonell JL, Abizanda P. Pilot study of a preventive multicomponent nurse intervention to reduce the incidence and severity of delirium in hospitalized older adults: MID-Nurse-P. Maturitas. 2016 Apr;86:86-94. doi: 10.1016/j.maturitas.2016.02.002. Epub 2016 Feb 8.

  PMID: 26921934 BACKGROUND

• Recasens-López M, Villamor-Ordozgoiti A, Sanz-Díez M, Sánchez-Morillo M, Serna-Landete R, Asensio-Rubio Y. Eficacia de un plan de cuidados de enfermería específico para el paciente con delirio. Rev Cubana Enfermer. 2019;35(1).

  BACKGROUND

• Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.

  PMID: 30076080 BACKGROUND

• Sánchez E. Prevención del delirium en el paciente anciano: diseño y evaluación de una intervención no farmacológica en el ámbito hospitalario. Universidad Complutense de Madrid. 2015.

  BACKGROUND

• Carrera C. Rol de enfermería en la prevención del delirium en ancianos hospitalizados con fractura de cadera: Recomendaciones generales. Enferm glob. 2012;11(27): 356-78.

  BACKGROUND

MeSH Terms

Conditions

Delirium; Frailty

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathologic Processes

Study Officials

• Miriam Moreno, RN,MSC,PhDc

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 13, 2025
• Study Start: October 26, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)