Nursing Intervention to Reduce Incidence and Duration of Delirium in Patients in Intensive Care

NCT05172583 | Unknown

• 1 other identifier: 53487
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Delirium is a cognitive alteration of acute onset and fluctuating course, characterized by the reduced capacity to pay attention to the environment, memory impairment, disorientation, language, and perception alteration. Its incidence varies between 20 and 90% in ICU patients. It shows high variability in both incidence and typology, representing a phenomenon of great interest to nursing, who can make timely interventions. General objective: To determine the effectiveness of nursing interventions based on the Dynamic Symptoms Model and scientific evidence, compared to daily care, for reducing the incidence and duration of delirium in people hospitalized in the adult ICU. Methodology: Study with a quantitative approach, experimental design of the type Randomized Controlled Clinical Trial of parallel groups, phase III in which the effectiveness and safety of the intervention designed in a particular population are evaluated, such as the ICU population, who are older risk of developing delirium. The sample will be 71 people for the intervention group and 142 for the control group, with a 2: 1 ratio. Expected outcome: The primary results are: reduce the incidence and duration of delirium in ICU patients, and the secondary outcomes are: shorter ICU stay, mechanical ventilation, use of physical restraints, less pain intensity, and more days in RASS between -2 and + 1. Risk: Greater than the minimum.

Conditions

Delirium

Keywords

Delirium; Intensive Care Units; Disease Prevention; Evaluation of the Efficacy-Effectiveness of Interventions; Non-pharmacological interventions

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive state, presence or absence of delirium with Confusion Assessment Method for the Intensive Care Unit CAM-ICU scale

  The possible results are positive or negative for delirium

  Through ICU length of stay, an average of 8 days.

Secondary Outcomes (5)

• Fluctuations in consciousness with Richmond Agitation-Sedation Scale (RASS).

  Through ICU length of stay, an average of 8 days.

• Changes in the Pain intensity. with Campbell scale in non-communicative critical patients, and Visual Analog Scale (VAS) in communicative critical patients.

  Through ICU length of stay, an average of 8 days.

• length of stay in ICU

  Through ICU length of stay, an average of 8 days.

• Mechanical ventilation

  Through ICU length of stay, an average of 8 days

• Physical restrictions

  Through ICU length of stay, an average of 8 days.

Study Arms (2)

Control

ACTIVE COMPARATOR

The control groups will receive the nursing interventions that are performed daily in the adult ICU

Behavioral: Control

Experimental

EXPERIMENTAL

Interventions for this group are based on the Dynamic Symptom Model and scientific evidence

Behavioral: Interventions to reduce delirium based on DSM and scientific evidence

Interventions

Control BEHAVIORAL

The control groups will receive the nursing interventions that are performed daily in the adult ICU. These are orientation in time, space, and place, accompaniment of the family for two hours in the morning and two hours in the afternoon, physical therapy once a day according to the patient's condition, medication with conscious sedation, and progressive reduction analgesics. opioids and benzodiazepines.

Control

Interventions to reduce delirium based on DSM and scientific evidence BEHAVIORAL

The interventions are designed from the structure of the Dynamic Symptoms Model (DSM), taking into account the antecedents of delirium, physiological such as the medical condition of mechanical ventilation and pain, and drug treatment with sedatives and analgesics; the psychological, social, and spiritual antecedents with stimulation in the values, life experience, personality and spirituality, and the environmental antecedents with an adaptation of the physical conditions of the ICU. In addition, previous experience with identification and care of concomitant symptoms such as fear, confusion, restlessness, loneliness, and discomfort, and with the measurement and classification of the trajectory of delirium when it occurs, will also be considered. The interventions follow the scientific evidence, mainly from the ABCDEF bundle. All interventions are non-pharmacological.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People admitted to the adult intensive care unit
• People over 18 years of age.
• People who are agree to participate in the study by signing the informed consent.
• People who have no delirium at the time of recruitment (CAM - negative ICU).

You may not qualify if:

• People with any cognitive disorder or neurosurgical pathology.

Sponsors & Collaborators

• Universidad Surcolombiana: lead
• Universidad Nacional de Colombia: collaborator

Study Sites (1)

Hospital Universitario Hernando Moncaleano Perdomo

Neiva, Huila Department, 410010, Colombia

RECRUITING

Related Publications (7)

• Vahia VN. Diagnostic and statistical manual of mental disorders 5: A quick glance. Indian J Psychiatry. 2013 Jul;55(3):220-3. doi: 10.4103/0019-5545.117131. No abstract available.

  PMID: 24082241 RESULT

• Mitchell ML, Kean S, Rattray JE, Hull AM, Davis C, Murfield JE, Aitken LM. A family intervention to reduce delirium in hospitalised ICU patients: A feasibility randomised controlled trial. Intensive Crit Care Nurs. 2017 Jun;40:77-84. doi: 10.1016/j.iccn.2017.01.001. Epub 2017 Feb 27.

  PMID: 28254205 RESULT

• Lee A, Mu JL, Chiu CH, Gin T, Underwood MJ, Joynt GM. Effect of motor subtypes of delirium in the intensive care unit on fast-track failure after cardiac surgery. J Thorac Cardiovasc Surg. 2018 Jan;155(1):268-275.e1. doi: 10.1016/j.jtcvs.2017.08.139. Epub 2017 Sep 30.

  PMID: 29110954 RESULT

• Park SA, Tomimaru Y, Shibata A, Miyagawa S, Noguchi K, Dono K. Incidence and Risk Factors for Postoperative Delirium in Patients After Hepatectomy. World J Surg. 2017 Nov;41(11):2847-2853. doi: 10.1007/s00268-017-4079-3.

  PMID: 28608014 RESULT

• Von Rueden KT, Wallizer B, Thurman P, McQuillan K, Andrews T, Merenda J, Son H. Delirium in Trauma Patients: Prevalence and Predictors. Crit Care Nurse. 2017 Feb;37(1):40-48. doi: 10.4037/ccn2017373.

  PMID: 28148613 RESULT

• Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.

  PMID: 18495054 RESULT

• Ely EW. The ABCDEF Bundle: Science and Philosophy of How ICU Liberation Serves Patients and Families. Crit Care Med. 2017 Feb;45(2):321-330. doi: 10.1097/CCM.0000000000002175.

  PMID: 28098628 RESULT

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Ángela M Henao Castaño, PhD

  Universidad Nacional de Colombia

  STUDY DIRECTOR

• Dolly O Arias Torres, PhD

  Universidad Surcolombiana

  STUDY CHAIR

Central Study Contacts

Luz O Gómez Tovar, MSN

CONTACT

+57 3134747420; omaira.gomez@usco.edu.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be triple-blind, since the participants and their relatives, the research assistant who measures the outcome variables, and who performs the information analysis process, will not know the assignment of the study, control and intervention groups, due to They will be named by categories coded by the research assistant who performs the randomization.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruit upon admission to the ICU, patients and family members are asked to sign the informed consent and confidentiality agreement. The Assignment to the groups will be random. All interventions will be performed and will be adjusted according to the patient's condition. If the patient is recruited while under the effects of sedation, they will be asked to sign the informed consent when she is conscious; if she does not wish to participate, the withdrawal will be completed, and she will be excluded from the study. Follow-up will be done each shift, where the outcome variables will be measured and recorded in an established format.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: December 29, 2021
• Study Start: July 5, 2021
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)