Investigation of the Effect of a Venous Thromboembolism Prevention Care Bundle After Hip Arthroplasty: A Non-Randomized Controlled Study
Investigation of the Effect of a Venous Thromboembolism Prevention Care Bundle After Hip Arthroplasty: A Non-Randomized Controlled Study
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.
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).
Data Collection and Longitudinal Follow-Up To accurately capture the impact of the care bundle, the study employs a rigorous 90-day longitudinal follow-up design. Data collection begins with a Descriptive Data Form to capture baseline demographics and clinical characteristics. During the inpatient period, a researcher-developed Clinical Follow-up Chart is utilized to monitor daily physiological parameters, including leg circumference, Homan's sign, localized edema, erythema, vital signs, and International Normalized Ratio (INR) levels for coagulation tracking.
The psychosocial and functional recovery of the patients is also a major focus. Validated tools, including a Postoperative Comfort Scale, a Fear of Falling Scale, and the Newcastle Satisfaction with Nursing Care Scale, are administered to comprehensively assess the patient experience during the mobilization and recovery process.
Following hospital discharge, the monitoring continues seamlessly for 3 months. A specialized Post-Discharge 90-Day Follow-up Chart is used to track the patients in their home environment. This ensures that any hospital admissions or readmissions due to suspected VTE symptoms (such as sudden leg swelling, acute pain, or shortness of breath) are accurately recorded and analyzed.
Funding Status A grant application to support the logistical and material requirements of this clinical research has been submitted to The Scientific and Technological Research Council of Türkiye (TUBITAK) and is currently under official evaluation.
Inclusion Criteria:
Exclusion Criteria: