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Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery
Sponsor: Cardenal Herrera University
Summary
The main objective of this research will be to investigate whether the control of care provided by the family/caregiver can prevent the incidence 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 at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) and at the Manises Hospital (Manises Health Department, Spain), who have had hip fracture surgery and are accompanied by a family member/caregiver. The research will take place in these centers because the rooms are private, which allows there to be no interference between the intervention under study (in the IG) or the standard care (CG).
Official title: Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2025-01-15
Completion Date
2028-07-31
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
"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.
Standard 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 (2)
Hospital Manises
Manises, Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain