The Effect of a VTE Prevention Care Bundle in Total Hip Arthroplasty Patients

Summary

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.

Conditions

• Venous Thromboembolism
• Total Hip Arthroplasty (THA)
• Deep Vein Thrombosis

Interventions

OTHER

VTE Prevention Care Bundle

The VTE Prevention Care Bundle is a comprehensive, multi-component nursing intervention designed specifically for patients undergoing hip replacement surgery. It consists of five structured components applied systematically: 1) Face-to-face patient education regarding VTE risks and preventive strategies; 2) Specific in-bed ankle-pumping and range-of-motion exercises; 3) An early and progressive mobilization protocol; 4) Guided daily fluid management; and 5) Continuous monitoring and proper application of mechanical prophylaxis (elastic compression stockings). These components are implemented collectively to synergistically reduce the risk of postoperative venous thromboembolism.

OTHER

Standard Routine Care

Patients receive standard routine orthopedic nursing care provided by the clinic, including standard physician-prescribed medical prophylaxis and routine mobilization practices, without the specific, structured elements of the VTE Prevention Care Bundle.

Sponsors & Collaborators

• The Scientific and Technological Research Council of Türkiye (TUBITAK)

  collaborator UNKNOWN

• Murat Erten

  lead OTHER

Principal Investigators

• Murat Erten, Lecturer · Hasan Kalyoncu University

• Ayla Yava, Professor · Hasan Kalyoncu University

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-17

Primary Completion

2026-09-15

Completion

2026-10-05

Countries

• Turkey (Türkiye)

Study Locations