Delirium Zero protocol to prevent delirium after hip fracture surgery
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
NA · Cardenal Herrera University · NCT07202208
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Cardenal Herrera University (other) |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT07202208 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participants will be patients over 65 years old * Admitted to the orthopedic hospitalization units of the La Fe University and Polytechnic Hospital (La Fe health department, Valencia, 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: * 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 before entering the trauma hospitalization unit, they have been in the emergency room for more than 36 hours. * That they present brain alterations (tumors, occupying lesions).
Where this trial is running
Valencia, Valencia
- Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Laura García Garcés Principal Investigator., PhD
- Email: laura.garcia19@uchceu.es
- Phone: (+34) 961369000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hip Fracture, Delirium - Postoperative, hip fracture, Family, Care, Care Protocol, Delirium, Caregiver