RecruitingNot ApplicableNCT07202208

Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery

Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial


Sponsor

Cardenal Herrera University

Enrollment

140 participants

Start Date

Jan 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of this research will be to investigate whether the control of care provided by the family/caregiver can prevent the onset of delirium in individuals undergoing surgical intervention for hip fracture. The research will be a randomized, single-blind, parallel, two-arm clinical trial that compares two conditions: intervention group, hereafter IG (Delirium Zero protocol based on a space-temporal orientation poster for the patient, a clock hung on the wall next to the orientation poster, and a checklist for the preventive measures taken by the caregiver/family), and control group, hereafter CG (standard of care). The participants will be patients over 65 years old, admitted to the trauma hospitalization units of the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain), operated on for hip fracture and accompanied by a relative/caregiver. The research will be carried out at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) because it is the reference hospital for the Valencian Community, and because the rooms in this center are private, which allows for no interference between the intervention under study (in GI) or the standard care (GC).


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called "Delirium Zero" protocol and a procedure called Standard of Care to prevent Delirium. for people with delirium - postoperative and hip fracture. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURE"Delirium Zero" protocol

The protocol consists of: i) a patient orientation poster placed in the room in a visible location for the patient, with information updated daily by the family member/caregiver; ii) a clock hung on the wall next to the orientation poster; and iii) a verification sheet of the preventive measures taken by the caregiver/family member, where the caregiver/family member must indicate daily the frequency with which preventive activities have been performed. The caregiver/family member will have this document in the patient's room all day and will need to complete it at the end of the day, when the nurse will collect it for safekeeping. From that day until the patient is discharged, the nurse responsible for the patient's care will be responsible for providing a new verification sheet of the preventive measures taken by the family member/caregiver and collecting it at the end of the day once it has been completed by the family member/caregiver.

PROCEDUREStandard of Care to prevent Delirium.

All participants in the study, regardless of the assigned group, receive information on strategies to prevent delirium, which is provided in the participant information sheet and includes an infographic and a guide for patients and their families. Participants are advised to keep this document accessible throughout their stay for reference.


Locations(1)

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07202208


Related Trials