Verification of XAPPORT: a Decision Support App for Physicians Used for Patients Anticoagulated With Rivaroxaban in Terms of Anticoagulation Management in Elective Surgery: Verification Process of Medical Decision Algorithm

Study Overview
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Brief Summary
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This study shall determine whether XAPPORT - a mobile device app based on different guidelines, the summary of product characteristics of rivaroxaban, and clinical facts and practice - provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.

Detailed Description
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Study design: retrospective/prospective Observational study

Official Title
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VeriXAPPORT: Verification of XAPPORT: a Decision Support App for Physicians Used for Patients Anticoagulated With Rivaroxaban in Terms of Anticoagulation Management in Elective Surgery: Verification Process of Medical Decision Algorithm

Conditions
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Atrial Fibrillation, Venous Thromboembolism, Pulmonary Embolism

Intervention / Treatment
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* Other: XAPPORT
* Other: Expert Panel (gold standard)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female or male patient ≥18 years who provided signed and dated informed consent to the use of their medical data Patient was treated with rivaroxaban before and after surgery because of non-valvular atrial fibrillation (NVAF) or venous thromboembolism/pulmonary embolism (VTE/PE) Elective surgery in a department of General Surgery or Orthopedics / Trauma Surgery was performed within the last 12 months before study start The patient has been discharged from hospital Patient's medical records are available for data entry Exclusion Criteria: Patient participated in an interventional drug study within 3 months prior to the surgery and discharge from hospital

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NVAF Patients<br>Adult female and male patients with non-valvular atrial fibrillation (NVAF) treated with rivaroxaban before and after surgery | Other: XAPPORT<br>* A mobile device app based on different guidelines provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.<br>Other: Expert Panel (gold standard)<br>* A national panel of experts comprising anesthetists and surgeons from various disciplines advised in developing an algorithm supporting physicians how to approach the perioperative management of anticoagulation in patients receiving rivaroxaban and requiring elective surgery.<br>|
| VTE/PE Patients<br>Adult female and male patients with venous thromboembolism/pulmonary embolism (VTE/PE) treated with rivaroxaban before and after surgery | Other: XAPPORT<br>* A mobile device app based on different guidelines provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.<br>Other: Expert Panel (gold standard)<br>* A national panel of experts comprising anesthetists and surgeons from various disciplines advised in developing an algorithm supporting physicians how to approach the perioperative management of anticoagulation in patients receiving rivaroxaban and requiring elective surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement rate between the recommendations of XAPPORT and the consolidated recommendations of a qualified Expert Panel (gold standard). |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for discrepancies between the recommendations of XAPPORT and the consolidated recommendations of the qualified Expert Panel (gold standard). |  | 4 months |