An interventional study of "Delirium Zero" protocol and Standard of Care to prevent Delirium. in Hip Fracture and Delirium - Postoperative, sponsored by Cardenal Herrera University. Recruiting at 2 sites in Spain. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Prevention
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).
842 studies on the registry are indexed under Hip Fractures; 165 are open to participants now.
This study's planned enrollment of 112 is above the median of 86 across 533 interventional studies indexed under Hip Fractures.
Browse Hip Fractures studies →Cardenal Herrera University is the lead sponsor of 107 studies on the registry; 22 are open to participants now.
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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.
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.
The Control Group receives the standard of care to prevent delirium.
Procedure: Standard of Care to prevent Delirium.
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.
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.
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).
Time frame: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.
Delirium: severity
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 Based on the CAM scale, numerical scores are assigned to the evaluated criteria, which allows the intensity of the delirium symptoms to be quantified, with a score that ranges from 0 to 7, where a higher score indicates greater severity. Each of the symptoms is scored as follows: criterion 1 (acute onset and fluctuating course of mental state, rated as absent = 0, or present = 1), criterion 2 (inattention, rated as absent = 0, mild = 1 or marked = 2), criterion 3 (disorganized thinking, rated as absent = 0, mild = 1 or marked = 2) and criterion 4 (altered level of consciousness, where an alert state of consciousness is considered normal = 0, and the rest of the states are considered altered with these scores: vigilant = 1, lethargic = 1, stupor = 2, coma = 2).
Time frame: 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
Days of delirium. Once the patient is discharged, the principal investigator will record the total number of days the patient experienced delirium during their stay. Unit of measurement: days. Method of aggregation: absolute frequency. 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.
Time frame: 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
Number of delirium episodes during the stay. Once the patient is discharged, the principal investigator will record the total number of delirium episodes the patient experienced during their stay. Unit of measurement: number of episodes. Method of aggregation: absolute frequency. 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.
Time frame: 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
The Delirium Zero protocol is applied only to participants in the IG. Adherence to this protocol is measured by recording the frequency of delirium prevention measures. For each preventive measure, the frequency with which it was performed is indicated using a Likert-type scale with four frequency options: Never = 0, Sometimes = 1, Quite a bit = 2, and Always = 3. The measure of being accompanied at night by a family member/caregiver, and the measures related to poster completion, have two response options: No = 0 and Yes = 1. The score ranges from 0 to 36 in patients without glasses, hearing aids, or dentures, with higher scores indicating greater adherence to the protocol. This maximum score will be increased by 6 points for patients with glasses and/or 6 points for patients with hearing aids and/or 3 points for patients with dentures. In addition, an analysis of overall adherence will be performed.
Time frame: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.
Plan to share: No
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