Management of Non-pharmacologic Delirium With the Use of a Nursing-led E-health Project: a Randonmized Controlled Trial

NCT06809894 | Not Yet Recruiting

• 1 other identifier: PR098/24 (CSA PR35/2023)
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Application of an action protocol focused on the application of non-pharmacological interventions for managing delirium in the process of prevention, diagnosis and treatment, evaluated using an e-health intervention, with a tablet to introduce on it the data about the prevention, diagnostic and treatment process of each recluted patient, in the Igualada Hospital Center, once a day.

Conditions

Delirium Treatment; Delirium Confusional State; Delirium in Old Age

Keywords

Delirium; SCA; CAM; Older pacient; non-pharmacologic treatment; nurse

Outcome Measures

Primary Outcomes (3)

• Rate of patients who develop delirium

  It is performed on all patients admitted to geriatric unit with 3 or more risk criteria for the development of delirium. Its measurement is carried out in the morning shift using the Confussional Assesment Scale scale. The score is from 0 to 4 points, with a positive diagnosis being one with a score greater than 2. It compares the incidence of the control group and the intervention group.

  Its calculation is carried out during the 3 months of the study, and within each particular case, It is carried out in the morning every day, from admission to discharge of the patient, up to 3 days.

• Rate of patients diagnosed with delirium improving clinical severity

  Every patient with a positive diagnostic and an active treatment. The objective is to avaluate the reduction of the symptoms with the Delirium Rating Scale-R-98 scale, in the morning, comparing control gropu and interventional group . The score is from 0 to 48 points, with a positive diagnosis with severity symptoms in scores greater than 12 points.

  Its calculation is carried out during the three months of the study, and within each particular case, in the morning every day, from the beginning of diagnosis to the improvement of the patient, up to 3 days.

• Drug use rate for the treatment of delirium

  Carried out with the recorded on the e-health program and the observation of the clinical history of each patient who have had a positive diagnosis of delirium in their hospitalitzation in the geriatric unit and has recorded the use of drugs, like number of a day and type of drug, for their treatment. Comparation control group and intervention group.

  Its calculation is carried out during the 3 months of the study, and within each particular case, in the end of the patient hospitalitzation, up to 3 days.

Study Arms (2)

Quantitative study for the evaluation of the protocol's effectiveness

EXPERIMENTAL

A quantitative study is carried out in which the indices described in the description of the study are studied in order to assess the effectiveness of the implementation of delirium.

Procedure: Application of an action protocol for the management of delirium through the use of non-pharmacological interventions

Traditional ways to delirium management

ACTIVE COMPARATOR

The use of traditional ways to manage the delirium in hosoitalized older patient, based especially in the use of pharmacological interventions and mechanical patient restraint were compared with the new interventions includes in the new protocol to valorate the effectiveness of the new way to management delirium based in non-pharmacological interventions.

Other: Tradicional management of delirium

Interventions

Application of an action protocol for the management of delirium through the use of non-pharmacological interventions PROCEDURE

The interventions carried out stand out for being non-pharmacological, this avoiding the use of drugs and polypharmacy in elderly patients, avoiding the appearance of clinical complications derived from the side effects that the use of these substances can lead to in the patient. In addition, it also encourages the education of health professionals and nurses' families or caregivers in the management of delirium.

Also known as: orientation, mobilitzation, education, feeding assistance, Hypoxemia, Pain, fluid repletion, Therapeutic activities, Nursing Assessment and Intervention Interdisciplinar, Sleep enhancement, Vision and hearing adaptation

Quantitative study for the evaluation of the protocol's effectiveness

Tradicional management of delirium OTHER

The use of the pharmacological treatment and the mechanical patients restrain were de base of the traditional treatment in deliriums patient in the University hospital of Igualada, because of the less knowledge of the professionals and non-existence protocol of non-pharmacological interventions to management the delirium.

Also known as: pharmacology, mechanical restrain

Traditional ways to delirium management

Eligibility Criteria

• Age: 80 Years - 130 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age over 80 years
• Three risk factor to develop delirium, for example: sex (men), polypharmacy,urinary tract infections (UTIs) or strictures.
• Admission in geriatric unit.
• Have social support

You may not qualify if:

• Age under 80 years
• Eseeable death on admission not caused by delirium or delirium diagnosis on admission.

Sponsors & Collaborators

• Universitat de Lleida: lead
• Hospital d'Igualada: collaborator

Study Sites (1)

Hospital d'Igualada

Igualada, Barcelona, 08700, Spain

Location

Related Publications (9)

• Trzepacz PT, Mittal D, Torres R, Kanary K, Norton J, Jimerson N. Validation of the Delirium Rating Scale-revised-98: comparison with the delirium rating scale and the cognitive test for delirium. J Neuropsychiatry Clin Neurosci. 2001 Spring;13(2):229-42. doi: 10.1176/jnp.13.2.229.

  PMID: 11449030 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Wu YC, Tseng PT, Tu YK, Hsu CY, Liang CS, Yeh TC, Chen TY, Chu CS, Matsuoka YJ, Stubbs B, Carvalho AF, Wada S, Lin PY, Chen YW, Su KP. Association of Delirium Response and Safety of Pharmacological Interventions for the Management and Prevention of Delirium: A Network Meta-analysis. JAMA Psychiatry. 2019 May 1;76(5):526-535. doi: 10.1001/jamapsychiatry.2018.4365.

  PMID: 30810723 BACKGROUND

• Ludolph P, Stoffers-Winterling J, Kunzler AM, Rosch R, Geschke K, Vahl CF, Lieb K. Non-Pharmacologic Multicomponent Interventions Preventing Delirium in Hospitalized People. J Am Geriatr Soc. 2020 Aug;68(8):1864-1871. doi: 10.1111/jgs.16565. Epub 2020 Jun 12.

  PMID: 32531089 BACKGROUND

• Wilson JE, Mart MF, Cunningham C, Shehabi Y, Girard TD, MacLullich AMJ, Slooter AJC, Ely EW. Delirium. Nat Rev Dis Primers. 2020 Nov 12;6(1):90. doi: 10.1038/s41572-020-00223-4.

  PMID: 33184265 BACKGROUND

• Sánchez A, Abdelnour C, Giraldo M, et al. Guia d'abordatge del delirium. Pla de demències de Catalunya. 2022. 1-50.

  BACKGROUND

• Tobar E, Alvarez E. Delirium in hospitalised older adults. Revista médica clínica Las Condes . 2020;31(1):28-35.

  BACKGROUND

• Gallardo Navarro M, Martínez Martín M. Delirium in institutionalised elderly: a silent epidemic. Gerokomos . 2023 ;34(1):38-45.

  BACKGROUND

• Hshieh TT, Inouye SK, Oh ES. Delirium in the Elderly. Clin Geriatr Med. 2020 May;36(2):183-199. doi: 10.1016/j.cger.2019.11.001.

  PMID: 32222295 BACKGROUND

Related Links

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MeSH Terms

Conditions

Confusion; Delirium

Interventions

Educational Status; Nursing Assessment; Vision, Ocular; Pharmacokinetics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Nursing Process; Comprehensive Health Care; Patient Care Management; Health Services Administration; Light Signal Transduction; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Cell Physiological Phenomena; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena; Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Laia Fernandez Parra, Registred Nurse (RN) and MSc

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

• Gloria Tort Nassarre, Registred Nurse (RN), PhD

  Universitat de Lleida

  STUDY DIRECTOR

• Aida Bonet Auge, Registred Nurse (RN) and PhD

  Universitat de Lleida

  STUDY DIRECTOR

Central Study Contacts

Laia Fernández Parra, Registred Nurse (RN) and MSc

CONTACT

692832143; laia.fernandez@udl.cat

Aida Bonet Auge, Registred Nurse (RN), PhD

CONTACT

aida.bonet@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registred Nurse (RN) and MSc

Model Details: The study is developed through an experimental cases-control study, developing a quantitative model. A quantitative study is carried out in which the indicators described in the description of the study are studied in order to assess the effectiveness of the implementation of a delirium protocol.

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 March 2026, start of patient recruitement, it is estimated that it will take approximately 3 months to collect the entire necessary sample. The total sample is estimated to be completed in June 2027.
• Access Criteria: IP Laia Fernández Parra. Doctoral thesis supervisors, Gloria Tor Nassarre and Aida Bonet Auge. Only data strictly necessary for the project will be accessed. The instructions of the ethics committee are followed.

Locations

ES (1)