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

NCT ID: NCT07202208

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2028-07-31

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 onset 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 of the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain), operated on for hip fracture and accompanied by a relative/caregiver.

The research will be carried out at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) because it is the reference hospital for the Valencian Community, and because the rooms in this center are private, which allows for no interference between the intervention under study (in GI) or the standard care (GC).

Conditions

Hip Fracture; Delirium - Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Delirium Zero

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.

Group Type: EXPERIMENTAL

"Delirium Zero" protocol

Intervention Type: 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.

Standard of Care to prevent Delirium.

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Standard of Care to prevent Delirium.

Intervention Type: 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.

Interventions

"Delirium Zero" protocol

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.

Intervention Type: PROCEDURE

Standard of Care to prevent Delirium.

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.

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Politècnic i Universitari la Fe de València

UNKNOWN

Sponsor Role: collaborator

Cardenal Herrera University

OTHER

Sponsor Role: lead

Responsible Party

Laura García Garcés

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Laura García Garcés Principal Investigator., PhD

Role: CONTACT

laura.garcia19@uchceu.es

(+34) 961369000 ext. 64352

Facility Contacts

María Barrachina Alepuz Nursing supervisor

Role: primary

barrachina_marale@gva.es

(+34) 961244000 ext. 440616

Other Identifiers

PINV_05CNDE24

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DZ_Delirum Zero

Identifier Type: -

Identifier Source: org_study_id