An observational study in Hip Fractures (ICD-10 72.01-72.2), sponsored by People's Hospital Affiliated to Hubei University of Medicine. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by People's Hospital Affiliated to Hubei University of Medicine · Observational
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 284 is above the median of 200 across 418 observational studies indexed under Delirium.
Browse Delirium studies →This is the only study on the registry with People's Hospital Affiliated to Hubei University of Medicine as lead sponsor.
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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).
Exclusion Criteria:
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.
Behavioral: Risk Early Warning 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.
Behavioral: Standard Perioperative Care
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative baseline and Postoperative 3 days
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.
Time frame: 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.
Time frame: 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%.
Time frame: Immediately after the intervention
Plan to share: No
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