Investigation of the Effect of a Venous Thromboembolism Prevention Care Bundle After Hip Arthroplasty: A Non-Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Incidence of Venous Thromboembolism (VTE)
研究概览
简要总结
Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite standard prophylactic measures, the incidence of VTE can be significant, highlighting the need for comprehensive and structured nursing interventions. A "care bundle" approach-a targeted set of evidence-based practices performed collectively and reliably-has been shown to improve patient outcomes and minimize complications in various clinical settings.
This non-randomized controlled clinical trial aims to investigate the effect of a specifically designed VTE Prevention Care Bundle on clinical outcomes in patients recovering from total hip arthroplasty. The central hypothesis is that the systematic implementation of this care bundle will result in optimized clinical parameters, enhanced recovery experiences, and minimized VTE risks compared to standard routine care.
Study Design and Population:
The study utilizes a quasi-experimental, non-randomized controlled design. Participants are adult patients who have undergone total hip arthroplasty. The Autar DVT Risk Assessment Scale is utilized strictly as an objective filtering tool during the patient selection process (inclusion criteria). Participants are systematically assigned to either a control group or an intervention group based on the study protocol phases.
Interventions:
Control Group: Patients receive the standard, routine orthopedic nursing care provided by the hospital, alongside the standard medical prophylaxis prescribed by their attending physicians.
Intervention Group: Patients receive the specialized VTE Prevention Care Bundle. This comprehensive bundle consists of five core components:
Education: Providing verbal and written information to the patient during the preoperative period.
Early Mobilization: Ensuring controlled ambulation and mobilization in the early postoperative period.
Exercise: Instructing and monitoring in-bed ankle-pumping exercises.
Fluid Management: Encouraging adequate hydration and closely monitoring fluid intake.
Mechanical Prophylaxis: Ensuring the correct application and continuous monitoring of elastic compression stockings.
Data Collection and Follow-up Tools:
Data is collected systematically during the inpatient stay and throughout a 90-day post-discharge period using the following tools:
Descriptive Data Form: Records demographic and clinical characteristics (age, BMI, surgical history).
Clinical Follow-up Chart: A researcher-developed form tracking leg circumference, Homan's sign, edema, erythema, vital signs, and International Normalized Ratio (INR) levels.
Comfort Scale After Hip Prosthesis: A 26-item scale used to evaluate the patient's postoperative comfort.
Newcastle Satisfaction with Nursing Care Scale: A 19-item scale evaluating patient satisfaction with the nursing care received.
Likert-Type Fear of Falling Scale: Assesses patients' fear levels during mobilization.
Post-Discharge 90-Day Follow-up Chart: A researcher-developed form utilized to monitor any hospital admissions or readmissions due to suspected VTE symptoms (leg swelling, pain, shortness of breath) during the 3-month follow-up period.
Funding Status:
A grant application for this research project has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under evaluation.
详细描述
Background and Rationale Venous thromboembolism (VTE), which encompasses deep vein thrombosis (DVT) and pulmonary embolism (PE), remains a critical and potentially life-threatening complication following total hip arthroplasty (THA). Despite the routine administration of standard medical prophylaxis, the incidence of VTE can still be significant. This highlights a crucial gap that can be addressed through comprehensive and structured nursing interventions. The implementation of a "care bundle"-a targeted, structured set of evidence-based practices performed collectively and reliably-has been shown to improve patient safety, optimize clinical outcomes, and minimize complications in various high-risk clinical settings.
Study Workflow and Patient Journey This non-randomized controlled clinical trial evaluates the efficacy of a specialized VTE Prevention Care Bundle tailored for patients undergoing total hip arthroplasty. The patient journey begins at the preoperative stage. Candidates are initially screened using the Autar DVT Risk Assessment Scale, which serves strictly as an objective filtering tool to ensure patients meet the precise inclusion criteria regarding their baseline VTE risk.
Eligible participants are then systematically assigned to either the control or intervention phase of the study.
In the control phase, patients receive the standard, routine orthopedic nursing care provided by the hospital ward, alongside the standard pharmacological prophylaxis prescribed by their attending physicians.
In the intervention phase, patients receive the structured VTE Prevention Care Bundle administered by the research team. This bundle is integrated into the daily nursing workflow and focuses on five core pillars: proactive preoperative education (both verbal and written), structured early mobilization, scheduled in-bed ankle-pumping exercises, strict fluid management and hydration tracking, and the continuous monitoring of mechanical prophylaxis (elastic compression stockings).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and older.
- •Scheduled for elective primary total hip replacement surgery.
- •Conscious, oriented, and able to communicate effectively to complete questionnaires and understand education.
- •Volunteering to participate in the study and able to provide written informed consent.
- •Physically capable of participating in early mobilization and bed exercises postoperatively.
排除标准
- •Previous history of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE).
- •Known bleeding disorders or coagulation abnormalities (e.g., thrombophilia).
- •Contraindications to the use of mechanical prophylaxis/compression stockings (e.g., severe peripheral arterial disease, severe skin lesions, or leg ulcers).
- •Severe cognitive impairment, dementia, or psychiatric disorders that prevent cooperation with the study protocol and care bundle.
- •Bedridden prior to surgery or having severe neurological/musculoskeletal conditions completely preventing mobilization.
研究组 & 干预措施
Intervention Group: Care Bundle
Patients in this group receive the comprehensive VTE Prevention Care Bundle. This includes structured preoperative education, early mobilization protocols, specific in-bed exercises, guided fluid management, and continuous monitoring of mechanical prophylaxis.
干预措施: VTE Prevention Care Bundle (Other)
Control Group: Standard Care
Patients in this group receive standard routine orthopedic nursing care and medical prophylaxis as prescribed by their physicians. No additional study-specific care bundle interventions are applied.
干预措施: Standard Routine Care (Other)
结局指标
主要结局
Incidence of Venous Thromboembolism (VTE)
时间窗: Up to 90 days postoperatively
The number of patients who develop symptomatic or asymptomatic Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), as confirmed by physician diagnosis and standard diagnostic imaging methods
次要结局
- Changes in Calf Circumference(Up to hospital discharge, an average of 3 days)
- Incidence of Clinical Signs of DVT(Up to hospital discharge, an average of 3 days and at 90 days postoperatively)
- Incidence of Clinical Signs of Pulmonary Embolism (PE)(Up to hospital discharge, an average of 3 days at 90 days postoperatively)
- Coagulation Profile (INR levels)(Preoperatively, and postoperatively up to hospital discharge (an average of 3 days))
- Post-Hip Arthroplasty Comfort Scale(At hospital discharge, an average of 3 days post-surgery)
- Newcastle Nursing Care Satisfaction Scale(At hospital discharge, an average of 3 days post-surgery)
- Likert-Type Fear of Falling Scale(Preoperatively and at hospital discharge (an average of 3 days post-surgery))
研究者
Murat Erten
Hasan Kalyoncu University
Hasan Kalyoncu University