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

NCT07202208 | Recruiting DMC

• 2 other identifiers: DZ_Delirum ZeroPINV_05CNDE24
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Hip Fracture; Delirium - Postoperative

Keywords

hip fracture; Family; Care; Care Protocol; Delirium; Caregiver

Outcome Measures

Primary Outcomes (1)

• Delirium: incidence

  It will be measured using the Confusion Assessment Method scale. It will be measured twice daily, in the morning and in the afternoon, during all days of hospitalization, in all participants, regardless of the group they belong to. The scale allows for the detection of acute confusional state (delirium) using an algorithm that assesses four criteria: criterion 1 (presence of an acute and fluctuating change in the patient's mental status and behavior), criterion 2 (inattention), criterion 3 (disorganized thinking), and criterion 4 (altered level of consciousness). To establish the presence of delirium, the presence of criteria 1 and 2 is mandatory, as well as any one of criteria 3 and 4. A criterion is considered present when: the questions are answered affirmatively (for criteria 1, 2, and 3) and when the level of consciousness is other than alert (for criterion 4).

  Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.

Secondary Outcomes (4)

• Delirium: severity

  Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.

• Delirium. Days of duration

  Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.

• Delirium: number of episodes

  Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.

• Adherence to the Delirium Zero protocol

  Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.

Study Arms (2)

Delirium Zero

EXPERIMENTAL

In addition to the standard of care that the Control Group receives, the Intervention Group (Delirium Zero) will be subjected to the 'Delirium Zero' protocol.

Procedure: "Delirium Zero" protocol; Procedure: Standard of Care to prevent Delirium.

Control Group

ACTIVE COMPARATOR

The Control Group receives the standard of care to prevent delirium.

Procedure: Standard of Care to prevent Delirium.

Interventions

"Delirium Zero" protocol PROCEDURE

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.

Delirium Zero

Standard of Care to prevent Delirium. PROCEDURE

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.

Control Group; Delirium Zero

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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).

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Hospital Universitario La Fe: collaborator

Study Sites (2)

Hospital Manises

Manises, Valencia, 46940, Spain

NOT YET RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

MeSH Terms

Conditions

Hip Fractures; Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Laura García Garcés Principal Investigator., PhD

CONTACT

(+34) 961369000; laura.garcia19@uchceu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized Clinical Trial, simple blind, parallel, two-arm.

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: October 1, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)