The Effect of a VTE Prevention Care Bundle in Total Hip Arthroplasty Patients (VTE-CARE-THA)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Mardin、トルコ（Türkiye）
- Mardin Training and Research Hospital, Kızıltepe State Hospital
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
|
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.
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アクティブコンパレータ：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence of Venous Thromboembolism (VTE)
時間枠：Up to 90 days postoperatively
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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
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Up to 90 days postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in Calf Circumference
時間枠：Up to hospital discharge, an average of 3 days
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easurement of calf circumference (in centimeters) using a standard tape measure to monitor for swelling, which is a clinical sign of potential Deep Vein Thrombosis (DVT).
Measurements will be taken bilaterally.
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Up to hospital discharge, an average of 3 days
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Incidence of Clinical Signs of DVT
時間枠：Up to hospital discharge, an average of 3 days and at 90 days postoperatively
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The number of patients exhibiting local clinical signs of DVT, including increased localized calf temperature, redness, and tenderness/pain in the lower extremities.
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Up to hospital discharge, an average of 3 days and at 90 days postoperatively
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Incidence of Clinical Signs of Pulmonary Embolism (PE)
時間枠：Up to hospital discharge, an average of 3 days at 90 days postoperatively
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The number of patients exhibiting clinical signs indicative of PE, such as sudden onset shortness of breath, chest pain, coughing, or tachycardia.
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Up to hospital discharge, an average of 3 days at 90 days postoperatively
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Coagulation Profile (INR levels)
時間枠：Preoperatively, and postoperatively up to hospital discharge (an average of 3 days)
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International Normalized Ratio (INR) levels will be recorded from patient charts to monitor coagulation status and the effectiveness of medical prophylaxis.
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Preoperatively, and postoperatively up to hospital discharge (an average of 3 days)
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Post-Hip Arthroplasty Comfort Scale
時間枠：At hospital discharge, an average of 3 days post-surgery
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Comfort Scale After Hip Prosthesis was used.
Total scores range from 26 to 130. Higher scores indicate higher levels of comfort (a better outcome).
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At hospital discharge, an average of 3 days post-surgery
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Newcastle Nursing Care Satisfaction Scale
時間枠：At hospital discharge, an average of 3 days post-surgery
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Newcastle Satisfaction with Nursing Care Scale was used.
Total scores range from 19 to 95.
Higher scores indicate higher levels of patient satisfaction with nursing care (a better outcome).
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At hospital discharge, an average of 3 days post-surgery
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Likert-Type Fear of Falling Scale
時間枠：Preoperatively and at hospital discharge (an average of 3 days post-surgery)
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Likert-Type Fear of Falling Scale was used.
Total scores range from 1 to 4. Higher scores indicate higher levels of fear of falling (a worse outcome).
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Preoperatively and at hospital discharge (an average of 3 days post-surgery)
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Murat Erten, Lecturer、Hasan Kalyoncu University
- スタディディレクター：Ayla Yava, Professor、Hasan Kalyoncu University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HRÜ/25.11.44
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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