Delirium Zero protocol to prevent delirium after hip fracture surgery
Official title: Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
Run by Cardenal Herrera University · NCT07202208 · Data updated 2026-11-12
This trial will try whether a family-led Delirium Zero protocol (orientation poster, wall clock, and a caregiver checklist) can prevent delirium in people over 65 having hip fracture surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Cardenal Herrera University Academic / other |
| Locations | 2 sites (Manises, Valencia and 1 other locations) |
| Status | Recruiting |
| Started | January 15, 2025 |
| Main results expected | July 31, 2028 |
| Study ends | July 31, 2028 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07202208 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 65 or older undergoing hip fracture surgery at La Fe Hospital who are accompanied by a literate, Spanish-speaking family caregiver and do not have severe preexisting cognitive or major psychiatric disorders.
✕Probably not a fit
Patients with severe cognitive impairment, major psychiatric illness, those already delirious on admission, or those without an available literate Spanish-speaking caregiver are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, single-blind, parallel two-arm trial at La Fe University and Polytechnic Hospital in Valencia comparing a Delirium Zero intervention delivered by a family caregiver with standard care. The Delirium Zero protocol uses a space-temporal orientation poster, a clock placed near the patient, and a checklist for caregivers to implement preventive measures. Participants are patients aged 65 and older undergoing hip fracture surgery who are accompanied by a literate, Spanish-speaking caregiver. The main outcome is onset of postoperative delirium, with standardized assessments performed during the hospital stay.
Why it matters
Potential benefit: If successful, the approach could lower rates of postoperative delirium and improve recovery and hospital outcomes for older adults after hip fracture surgery.
How similar studies have gone: Similar multicomponent, orientation-focused and family-involved delirium prevention programs (for example components of the Hospital Elder Life Program) have shown reductions in delirium risk, although the exact Delirium Zero package tested here is a more specific, locally implemented approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: \- 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's running
-
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain Recruiting -
Hospital Manises
Manises, Valencia, Spain Not yet recruiting
Study contacts
- Study coordinator: Laura García Garcés Principal Investigator., PhD
- Email: laura.garcia19@uchceu.es
- Phone: (+34) 961369000
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.