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

Recruiting now · Not applicable

Conditions studied: Hip Fracture, Delirium - Postoperative

In brief

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).

Key facts

Study ID

NCT07202208

Run by

Cardenal Herrera University

People needed

112

Starts

2025-01-15

Expected to finish

2028-07-31

Last updated by the study team

2026-07-10

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participants will be patients over 65 years old
• Admitted to the orthopedic hospitalization units of La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) and Manises Hospital (Manises Health Department, Spain).
• Who are undergoing surgery for hip fracture
• Accompanied by a family member/caregiver who understands Spanish and knows how to read and write it.

You may not qualify if…

• Delirium at the time of admission to the trauma guard (assessed with the CAM scale).
• Have previously been diagnosed with severe cognitive impairment according to the Pfeiffer scale, which corresponds to a score of 8-10 points.
• Have previously been diagnosed with any serious mental disorder (schizophrenic disorders, schizotypal disorders, persistent delusional disorders, substance-induced delusional disorders, schizoaffective disorders, other non-organic psychotic disorders, bipolar disorder, serious depressive episode with psychotic symptoms, and severe recurrent depressive disorders). - that they have delirium at the time of admission to the trauma room.
• That they have a language barrier, deep aphasia, coma, or terminal illness.
• That they have been previously enrolled in this study.
• That before the surgery they were admitted to a different hospital unit than those participating in the study, although they may then be transferred to one of these trauma units.
• That they present brain alterations (tumors, occupying lesions).

Where it is running

• Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (enrolling)
• Hospital Manises — Manises, Valencia, Spain

Full record on ClinicalTrials.gov

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