Hip Fractures (ICD-10 72.01-72.2)NCT06966947
Risk Early Warning Management for Postoperative Hip Fracture Rehabilitation and Delirium Prevention in Elderly Patients
An observational study of Hip Fractures (ICD-10 72.01-72.2), run by People's Hospital Affiliated to Hubei University of Medicine at 1 site in China.
Trial summary
This clinical study aims to evaluate the effectiveness of a perioperative risk early warning management strategy in patients undergoing surgical treatment for hip fractures. Hip fractures are common in elderly individuals and are associated with a high risk of postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures (ICD-10 72.01-72.2)
- What is being tested?
- Risk Early Warning Management and Standard Perioperative Care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study includes adult patients (aged ≥18 years) undergoing PFN fixation for hip fractures at Shiyan People's Hospital (January 2023-December 2023).
Who may be able to join
- Diagnosed with unilateral intertrochanteric fracture of the femur confirmed by imaging.
- Age 18 years or older.
- Met the indications for surgical treatment and underwent fracture surgery in the study hospital.
- Stable vital signs and clear consciousness postoperatively.
Who cannot join
- Presence of hematologic diseases such as coagulation dysfunction.
- Existing lower limb disability, invasive trauma, or other comorbid lesions.
- History of mental disorders, cognitive impairment, or poor compliance with treatment protocols.
Trial locations and contacts
1 site in 1 country.
China1 site
Shiyan People's Hospital (People's Hospital Affiliated to Hubei Medical College)
Shiyan
About this study
Official title: The Positive Impact of Risk Early Warning Management on Postoperative Rehabilitation Quality and Incidence of Delirium in Patients With Hip Fractures
This clinical study aims to evaluate the effectiveness of a perioperative risk early warning management strategy in patients undergoing surgical treatment for hip fractures. Hip fractures are common in elderly individuals and are associated with a high risk of postoperative complications. Traditional perioperative care may not sufficiently identify and respond to early signs of clinical deterioration.
In this study, patients with hip fractures admitted to the orthopedic department of a single hospital from January 2023 to December 2023 were divided into two groups based on their admission time. Patients admitted between June and December 2023 received the early warning risk management intervention (experimental group), while those admitted between January and May 2023 received routine perioperative care (control group). The early warning management system involved a scoring-based approach using vital signs such as heart rate, respiratory rate, blood pressure, body temperature, and consciousness level to classify patients' risk levels. Nursing staff responded with graded interventions, including enhanced monitoring and rapid physician notification for higher-risk patients.
Read more
The study retrospectively enrolled 284 patients in total, with 142 in each group. The primary outcomes include changes in coagulation function, self-care ability (measured by the Exercise of Self-care Agency Scale, ESCA), and hip joint functional recovery (measured by the Hospital for Special Surgery, HSS, score). Secondary outcomes include patient satisfaction and incidence of postoperative complications.
The central hypothesis is that perioperative risk early warning management will improve patient safety, enhance self-care capacity, reduce complications, and promote better recovery outcomes compared to routine care.
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Being tested
- Risk Early Warning Management, Standard Perioperative Care
- Keywords
- Risk early warning management, Hip fracture rehabilitation, Postoperative delirium prevention, Proximal femoral nail (PFN) surgery, Elderly orthopedic patients, Blood coagulation function, Self-care ability, Retrospective cohort study
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Early Warning ManagementBehavioural
This intervention involves a perioperative risk early warning management strategy for hip fracture patients. A dedicated team of nurses is responsible for monitoring vital signs (heart rate, blood pressure, respiratory rate, temperature, and consciousness level) to identify and respond to early signs of clinical deterioration.
The intervention follows a structured scoring system that classifies patients into different risk levels based on their vital signs:
Risk Score 0-4: Standard perioperative care and monitoring
Risk Score 5-7 (or single-item score ≥3): Intensive monitoring with vital sign checks every 4 hours and immediate physician notification if condition changes
Risk Score ≥7: Continuous monitoring, with immediate physician availability and ready access to emergency equipment The intervention aims to improve patient outcomes by ensuring early identification of deterioration and more rapid response to clinical changes. A red warning sign will also be placed at the patient's b
Standard Perioperative CareBehavioural
This is the standard care protocol for patients undergoing hip fracture surgery at the study hospital. It includes health education before surgery, regular vital sign monitoring, routine anticoagulation, and infection control management.
Patients will receive standard perioperative management, including preoperative counseling, assistance with rehabilitation exercises, and monitoring of clinical symptoms and vital signs throughout the surgical and recovery process.
There is no specific risk early warning scoring system in this group, and intervention is based on routine clinical monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Risk Early Warning Perioperative Management | Participants in this arm received a structured risk early warning management intervention during the perioperative period. The intervention included the establishment of a dedicated nursing team, systematic evaluation of vital signs (heart rate, respiratory rate, blood pressure, temperature, and consciousness), and scoring of patient condition based on a predefined risk assessment table.
Based on the risk score, patients received tiered monitoring and intervention:
Score 0-4: Routine care and monitoring
Score 5-7 or single item score = 3: Intensive monitoring every 4 hours and physician notification
Score ≥7: Continuous monitoring, immediate physician arrival, and bedside emergency preparedness This strategy aimed to detect and respond to patient deterioration early, thereby reducing complications and improving recovery outcomes. Receives: Behavioral: Risk Early Warning Management | |
| Routine Perioperative Management | Participants in this arm received standard perioperative care according to hospital guidelines. This included general health education prior to surgery, assistance during the perioperative period, routine postoperative care such as anticoagulation and infection prevention, regular vital signs monitoring, and standard nursing interventions. No specific early warning risk scoring or tiered response strategy was implemented. Receives: Behavioral: Standard Perioperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prothrombin Time (PT)
Prothrombin Time (PT) will be measured in seconds using a standardized coagulation analyzer to evaluate the extrinsic coagulation pathway. Preoperative and postoperative PT values will be compared between the intervention and control groups.
Measured: Preoperative baseline and Postoperative 3 days
Change in Activated Partial Thromboplastin Time (APTT)
Activated Partial Thromboplastin Time (APTT) will be measured in seconds to assess the intrinsic coagulation pathway. Preoperative and postoperative APTT values will be compared between groups.
Measured: Preoperative baseline and Postoperative 3 days
Change in Fibrinogen (FBG) Levels
Fibrinogen levels (g/L) will be quantified to reflect clotting factor concentration. Preoperative and postoperative FBG values will be compared between groups.
Measured: Preoperative baseline and Postoperative 3 days
Change in D-Dimer (D-D) Levels
D-dimer levels (mg/L) will be measured to evaluate fibrinolysis activity. Preoperative and postoperative D-D values will be compared between groups.
Measured: Preoperative baseline and Postoperative 3 days
Secondary outcomes (3)
Change in Exercise of Self-Care Agency Scale (ESCA) Score
The ESCA scale evaluates patients' self-care ability across four domains: self-concept, self-responsibility, self-care skills, and health knowledge. Scores range from low to high, with higher scores indicating better self-care agency. Scores will be compared before and after the intervention in each group.
Measured: Baseline (pre-intervention) and immediately after the intervention
Incidence of Postoperative Complications
Complications such as infection, thrombosis, delayed wound healing, and bleeding events will be monitored and recorded. The incidence rate will be compared between the intervention and control groups.
Measured: Perioperative period to 30 days after Endpoint (day of discharge)
Patient Satisfaction Rate
A satisfaction questionnaire will be administered to patients upon discharge. Responses will be categorized as satisfied, neutral, or dissatisfied. The satisfaction rate is calculated as: (satisfied cases / total cases) × 100%.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Fractures (ICD-10 72.01-72.2)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- People's Hospital Affiliated to Hubei University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966947
- Sponsor's protocol ID
- PeoplesHospitalHubei
- Status last verified
- May 2025
- First submitted
- 9 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Positive Impact of Risk Early Warning Management on Postoperative Rehabilitation Quality and Incidence of Delirium in Patients With Hip Fractures
- ClinicalTrials.gov ID
- NCT06966947
- Acronym / sponsor ID
- PeoplesHospitalHubei
- Conditions
- Hip Fractures (ICD-10 72.01-72.2)
- Keywords
- Risk early warning management, Hip fracture rehabilitation, Postoperative delirium prevention, Proximal femoral nail (PFN) surgery, Elderly orthopedic patients, Blood coagulation function, Self-care ability, Retrospective cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- People's Hospital Affiliated to Hubei University of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 May 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.
This clinical study aims to evaluate the effectiveness of a perioperative risk early warning management strategy in patients undergoing surgical treatment for hip fractures. Hip fractures are common in elderly individuals and are associated with a high risk of postoperative complications. Traditional perioperative care may not sufficiently identify and respond to early signs of clinical deterioration.
In this study, patients with hip fractures admitted to the orthopedic department of a single hospital from January 2023 to December 2023 were divided into two groups based on their admission time. Patients admitted between June and December 2023 received the early warning risk management intervention (experimental group), while those admitted between January and May 2023 received routine perioperative care (control group). The early warning management system involved a scoring-based approach using vital signs such as heart rate, respiratory rate, blood pressure, body temperature, and consciousness level to classify patients' risk levels. Nursing staff responded with graded interventions, including enhanced monitoring and rapid physician notification for higher-risk patients.
The study retrospectively enrolled 284 patients in total, with 142 in each group. The primary outcomes include changes in coagulation function, self-care ability (measured by the Exercise of Self-care Agency Scale, ESCA), and hip joint functional recovery (measured by the Hospital for Special Surgery, HSS, score). Secondary outcomes include patient satisfaction and incidence of postoperative complications.
The central hypothesis is that perioperative risk early warning management will improve patient safety, enhance self-care capacity, reduce complications, and promote better recovery outcomes compared to routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Early Warning Perioperative Management | – | Behavioral: Risk Early Warning ManagementParticipants in this arm received a structured risk early warning management intervention during the perioperative period. The intervention included the establishment of a dedicated nursing team, systematic evaluation of vital signs (heart rate, respiratory rate, blood pressure, temperature, and consciousness), and scoring of patient condition based on a predefined risk assessment table. Based on the risk score, patients received tiered monitoring and intervention: Score 0-4: Routine care and monitoring Score 5-7 or single item score = 3: Intensive monitoring every 4 hours and physician notification Score ≥7: Continuous monitoring, immediate physician arrival, and bedside emergency preparedness This strategy aimed to detect and respond to patient deterioration early, thereby reducing complications and improving recovery outcomes. |
| Routine Perioperative Management | – | Behavioral: Standard Perioperative CareParticipants in this arm received standard perioperative care according to hospital guidelines. This included general health education prior to surgery, assistance during the perioperative period, routine postoperative care such as anticoagulation and infection prevention, regular vital signs monitoring, and standard nursing interventions. No specific early warning risk scoring or tiered response strategy was implemented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study includes adult patients (aged ≥18 years) undergoing PFN fixation for hip fractures at Shiyan People's Hospital (January 2023-December 2023).
Key inclusion criteria (4 listed)
- Diagnosed with unilateral intertrochanteric fracture of the femur confirmed by imaging.
- Age 18 years or older.
- Met the indications for surgical treatment and underwent fracture surgery in the study hospital.
- Stable vital signs and clear consciousness postoperatively.
Key exclusion criteria (3 listed)
- Presence of hematologic diseases such as coagulation dysfunction.
- Existing lower limb disability, invasive trauma, or other comorbid lesions.
- History of mental disorders, cognitive impairment, or poor compliance with treatment protocols.
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 |
|---|---|---|
| Risk Early Warning ManagementThis intervention involves a perioperative risk early warning management strategy for hip fracture patients. A dedicated team of nurses is responsible for monitoring vital signs (heart rate, blood pressure, respiratory rate, temperature, and consciousness level) to identify and respond to early signs of clinical deterioration. The intervention follows a structured scoring system that classifies patients into different risk levels based on their vital signs: Risk Score 0-4: Standard perioperative care and monitoring Risk Score 5-7 (or single-item score ≥3): Intensive monitoring with vital sign checks every 4 hours and immediate physician notification if condition changes Risk Score ≥7: Continuous monitoring, with immediate physician availability and ready access to emergency equipment The intervention aims to improve patient outcomes by ensuring early identification of deterioration and more rapid response to clinical changes. A red warning sign will also be placed at the patient's b | Behavioural | Risk Early Warning Perioperative Management |
| Standard Perioperative CareThis is the standard care protocol for patients undergoing hip fracture surgery at the study hospital. It includes health education before surgery, regular vital sign monitoring, routine anticoagulation, and infection control management. Patients will receive standard perioperative management, including preoperative counseling, assistance with rehabilitation exercises, and monitoring of clinical symptoms and vital signs throughout the surgical and recovery process. There is no specific risk early warning scoring system in this group, and intervention is based on routine clinical monitoring. | Behavioural | Routine Perioperative Management |
Primary outcome
Change in Prothrombin Time (PT)
Time frame: Preoperative baseline and Postoperative 3 days
Prothrombin Time (PT) will be measured in seconds using a standardized coagulation analyzer to evaluate the extrinsic coagulation pathway. Preoperative and postoperative PT values will be compared between the intervention and control groups.
Change in Activated Partial Thromboplastin Time (APTT)
Time frame: Preoperative baseline and Postoperative 3 days
Activated Partial Thromboplastin Time (APTT) will be measured in seconds to assess the intrinsic coagulation pathway. Preoperative and postoperative APTT values will be compared between groups.
Change in Fibrinogen (FBG) Levels
Time frame: Preoperative baseline and Postoperative 3 days
Fibrinogen levels (g/L) will be quantified to reflect clotting factor concentration. Preoperative and postoperative FBG values will be compared between groups.
Change in D-Dimer (D-D) Levels
Time frame: Preoperative baseline and Postoperative 3 days
D-dimer levels (mg/L) will be measured to evaluate fibrinolysis activity. Preoperative and postoperative D-D values will be compared between groups.
3 secondary outcomes
Change in Exercise of Self-Care Agency Scale (ESCA) Score
Time frame: Baseline (pre-intervention) and immediately after the intervention
Incidence of Postoperative Complications
Time frame: Perioperative period to 30 days after Endpoint (day of discharge)
Patient Satisfaction Rate
Time frame: Immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures (ICD-10 72.01-72.2), run by People's Hospital Affiliated to Hubei University of Medicine at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prothrombin Time (PT) (time frame: Preoperative baseline and Postoperative 3 days). The study lists 4 primary outcomes in all. 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 13 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.