Hip FractureDZNCT07202208
Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery
A study testing "Delirium Zero" protocol in people with Hip Fracture and Delirium - Postoperative, run by Cardenal Herrera University at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Delirium - Postoperative
- What is being tested?
- "Delirium Zero" protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Jan 2025to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laura García Garcés Principal Investigator., PhD contact
Spain2 sites, 2 recruiting
- Not yet recruiting
Hospital Manises
Manises, Valencia, 46940
Laura González Hernández, Nursing assistant, 682064895 ext. 492989, gonzalez_lauraher@gva.es
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
María Barrachina Alepuz Nursing supervisor, (+34) 961244000 ext. 440616, barrachina_marale@gva.es
About this study
Official title: Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
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
- Being tested
- "Delirium Zero" protocol, Standard of Care to prevent Delirium.
- Keywords
- hip fracture, Family, Care, Care Protocol, Delirium, Caregiver
- Medical subject headings
- Hip Fractures, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Delirium Zero" protocolProcedure or surgery
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.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard of Care to prevent Delirium. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start15 Jan 2025
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial, simple blind, parallel, two-arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Responsible party
- Principal investigator, Laura García Garcés, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202208
- Sponsor's protocol ID
- DZ_Delirum Zero
- Other IDs
- PINV_05CNDE24
- Acronym
- DZ
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Delirium Zero Protocol to Prevent the Onset of Delirium in Patients Undergoing Hip Fracture Surgery: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07202208
- Acronym / sponsor ID
- DZ / DZ_Delirum Zero
- Conditions
- Hip Fracture, Delirium - Postoperative
- Keywords
- hip fracture, Family, Care, Care Protocol, Delirium, Caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial, simple blind, parallel, two-arm.
| Arm | Type | Receives |
|---|---|---|
| Delirium Zero | Experimental | Procedure: "Delirium Zero" protocol, Procedure: Standard of Care to prevent Delirium.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. |
| Control Group | Active comparator | Procedure: Standard of Care to prevent Delirium.The Control Group receives the standard of care to prevent delirium. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Delirium Zero" protocolThe 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. | Procedure or surgery | Delirium Zero |
| 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. | Procedure or surgery | Control Group, Delirium Zero |
Primary outcome
Delirium: incidence
Time frame: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.
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).
4 secondary outcomes
Delirium: severity
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
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
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
Time frame: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hip Fracture
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura García Garcés Principal Investigator., PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Delirium Zero" protocol in people with Hip Fracture and Delirium - Postoperative, run by Cardenal Herrera University at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura García Garcés Principal Investigator., PhD ((+34) 961369000 ext. 64352, laura.garcia19@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium: incidence (time frame: Baseline, from the patient's admission to the trauma unit until hospital discharge or assessedup to 6 weeks, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.