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

Cardenal Herrera University

Status: Enrolling

Conditions: Delirium - Postoperative; Hip Fracture

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07202208

DZ_Delirum Zero

PINV_05CNDE24 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 140 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Delirium Zero

Experimental group

Description:

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.

Treatment:

Procedure: Standard of Care to prevent Delirium.

Procedure: "Delirium Zero" protocol

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: Standard of Care to prevent Delirium.