Clinical trial NCT06966947: Risk Early Warning Management for Postoperative Hip Fracture Rehabilitation and Delirium Prevention in Elderly Patients
Official title: The Positive Impact of Risk Early Warning Management on Postoperative Rehabilitation Quality and Incidence of Delirium in Patients With Hip Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: People's Hospital Affiliated to Hubei University of Medicine
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Prothrombin Time (PT)
timeFrame: Preoperative baseline and Postoperative 3 days
measure: Change in Activated Partial Thromboplastin Time (APTT)
timeFrame: Preoperative baseline and Postoperative 3 days
measure: Change in Fibrinogen (FBG) Levels
timeFrame: Preoperative baseline and Postoperative 3 days
measure: Change in D-Dimer (D-D) Levels
timeFrame: Preoperative baseline and Postoperative 3 days
Secondary outcomes:
measure: Change in Exercise of Self-Care Agency Scale (ESCA) Score
timeFrame: Baseline (pre-intervention) and immediately after the intervention
measure: Incidence of Postoperative Complications
timeFrame: Perioperative period to 30 days after Endpoint (day of discharge)
measure: Patient Satisfaction Rate
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Shiyan
country: China
facility: Shiyan People's Hospital (People's Hospital Affiliated to Hubei Medical College)
Study officials:
References: