Clinical trial Recruiting at 1 site Interventional Ages 65 and up

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 typeInterventional
Ages65 Years and up
SexAll
Enrollment112 (estimated)
SponsorCardenal Herrera University
Academic / other
Locations2 sites (Manises, Valencia and 1 other locations)
StatusRecruiting
StartedJanuary 15, 2025
Main results expectedJuly 31, 2028
Study endsJuly 31, 2028
Registry record updatedJuly 10, 2026
Trial IDNCT07202208 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.