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NCT Number: NCT06966947

Risk Early Warning Management for Postoperative Hip Fracture Rehabilitation and Delirium Prevention in Elderly Patients

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.

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Key information

Conditions

Hip Fractures (ICD-10 72.01-72.2) Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shiyan People's Hospital (People's Hospital Affiliated to Hubei Medical College)

Shiyan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Risk Early Warning Management

Behavioral

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 Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Change in Exercise of Self-Care Agency Scale (ESCA) Score

    Time frame: Baseline (pre-intervention) and immediately after the intervention

    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.

  2. Incidence of Postoperative Complications

    Time frame: Perioperative period to 30 days after Endpoint (day of discharge)

    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.

  3. Patient Satisfaction Rate

    Time frame: Immediately after the intervention

    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%.

Sponsors and collaborators

Lead sponsor

People's Hospital Affiliated to Hubei University of Medicine

Other

Registry information

Official study title

The Positive Impact of Risk Early Warning Management on Postoperative Rehabilitation Quality and Incidence of Delirium in Patients With Hip Fractures

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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