Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism. — DEBRIEF-VTE  

Venous Thromboembolism Clinical Trial

Official title: Impact of Early Debriefing and Enhanced Educative Components on Direct Oral Anticoagulant Adherence After Venous Thromboembolism. The DEBRIEF-VTE Study

Status Recruiting

Clinical Trial Summary

Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated.

In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.

Clinical Trial Description

Venous thromboembolism (VTE) is a frequent multifactorial and potential life-threatening disease. Once VTE has been diagnosed, anticoagulation should be started and prolonged for at least three to six months in order to reduce the risk of fatal and non-fatal recurrences and long-term sequelae. The development of direct oral anticoagulants (DOACs) has represented a major advance in patients' care as there is evidence that DOACs are associated with a decreased risk of bleeding without loss in efficacy and as it simplifies treatment modalities for the patients and the physician. However, as DOACs do not require laboratory monitoring, adherence of anticoagulation is difficult to evaluate and traditional programs built on patients receiving VKA may no longer be applicable to patients on DOAC. In order to increase treatment adherence in patients on DOAC for an acute VTE and to improve the quality of life, the impact of specific educational programs on DOACs, taking in account both therapeutic (DOAC) and medical illness (VTE) dimensions needs to be investigated.

Design The "DEBRIEF-VTE" trial is a multicenter randomized trial with blind evaluation and using a Zelen randomization process comparing a standardized follow-up visit at one month associated with a "debriefing and enhanced educative components" versus a standardized follow-up visit at one month alone (i.e.; without debriefing process).

All patients meeting the inclusion and none of the exclusion criteria are eligible for randomization. They will be randomized 1:1 to one of two allocated groups:

• Experimental group: a standardized follow-up visit at one month associated with "debriefing and enhanced educative component"

• Control group: a standardized follow-up visit at one month alone (i.e.; without "debriefing and educative component") Randomization will be performed using a two-step methodology described by Zelen et al.

• Stratification by:

• Center

• DVT or PE

• Presence of a major risk factor (either transient or persistent) or not (unprovoked VTE) At visit 1 (inclusion, 0-7 days): Inclusion of patients using the first written informed consent to accept a standard follow-up (visit at 1 month and 6 months) without mentioning randomization at one month performed in order to allocate patients to have, or to not have, debriefing and enhanced educative components. Study medication will be administered with complete explanation about doses and a classical therapeutic information regarding DOAC and clinical signs of recurrent VTE and bleeding (one treatment box with 400 pills of apixaban at 5 mg for the first 6 months of therapy) will be performed.

Visit 2 (30 days):

• Before the visit 2, review of all the inclusion and exclusion criteria and compute creatinine clearance using Cockcroft-Gault method ; if all eligibility criteria are satisfied, randomization of the patient;

• After randomization, during the visit 2:

• For patients allocated to the experimental group: signature of the second written informed consent describing the debriefing and enhanced educative components and objective on quality of life

• For patients allocated to the control group: no second written informed consent is required

Visit 3/ET (180 days):

• Evaluate quality of life (PembQOL if PE, VEINES-Qol if DVT, EQ-5D for all patients), residual symptoms (mMRC and MDP scale if PE, Villalta if DVT) depression (HAD), recurrent VTE, bleeding, hospitalizations, death

The primary objective is to demonstrate that, in patients with an acute episode of VTE treated for at least 6 months, early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE is associated with an increased adherence to apixaban therapy at 6 months than after a standardized visit alone at one month (adherence measured by the MEMSCap™ Medication Event Monitoring System Cap (WestRock, USA & Switzerland). In patients with an acute episode of VTE treated for at least 6 months, the main hypothesis is that early debriefing and educative components added to a standardized visit one month after an acute VTE has the potential to improve patient's adherence to APIXABAN therapy at 6 months of follow-up.

Secondary objectives are to evaluate the impact of early debriefing and enhanced educative components added to a standardized visit one month after an acute VTE on the following at 6 months of treatment : quality of life (EQ-5D for all, PembQOL if PE, VEINES-Qol if DVT), residual symptoms (MMRC and multidimensional dyspnea profile(MDP) scales if PE, Villalta if DVT), depression (HAD), recurrent VTE, bleeding,hospitalizations and death.

150 patients will be included Duration of the inclusion period: 18 months Duration of participation for each patient: 6 months Total duration of the study: 24 months ;

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

• NCT number: NCT04141254
• Study type: Interventional
• Source: University Hospital, Brest
• Contact: Francis COUTURAUD, PhD
• Phone: 2 98 34 73 48
• Email: francis.couturaud@chu-brest.fr
• Status: Recruiting
• Phase: Phase 3
• Start date: December 27, 2019
• Completion date: December 2021