The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients

Sun Yat-sen University

Status: Enrolling

Conditions: Thrombosis, Venous

Treatments: Behavioral: Medication Therapy Management (MTM) model

Study type: Interventional

Funder types: Other

Identifiers

NCT06998745

2024ZSLYEC-572

Details and patient eligibility

About

Anticoagulants are classified as high-risk medications, with their main adverse drug events (ADEs) being recurrent venous thromboembolism (VTE) and bleeding events.Postoperative colorectal cancer (CRC) patients exhibit a high probability of recurrent VTE and bleeding during anticoagulation therapy.The Medication Therapy Management (MTM) model will contribute to reducing ADEs associated with anticoagulants in CRC patients.

Full description

Anticoagulants are classified as high-risk medications, with their main adverse drug events (ADEs) being recurrent venous thromboembolism (VTE) and bleeding events.Postoperative colorectal cancer (CRC) patients exhibit a high probability of recurrent VTE and bleeding during anticoagulation therapy. In clinical practice, a considerable proportion of patients have experienced inappropriate prescribing of anticoagulants. Following a bleeding event, the decision on whether and when to initiate anticoagulation therapy requires individualized assessment by physicians and pharmacists based on each patient's specific condition. Moreover, over a quarter of patients prematurely discontinue anticoagulation therapy, which substantially increases their risk of VTE recurrence.Effective management of the use of anticoagulants holds significant importance. Pharmacist-led anticoagulation management can significantly improve the appropriateness of anticoagulant therapy and reduce total bleeding risk. However, the efficacy of various intervention approaches, such as medication reconciliation and medication monitoring, as well as the timing of intervention, has not been conclusively established. This study integrates multifaceted pharmacist interventions within the Medication Therapy Management (MTM) model, intervening at patient admission, during hospitalization, and post-discharge, to evaluate the impact of the MTM model on the efficacy and safety of anticoagulation therapy.

Enrollment: 327 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with histologically confirmed CRC and symptomatic or incidental VTE who received anticoagulant treatment.
2. CRC patients with VTE treated with an anticoagulant for at least 3 moths.

Exclusion criteria

1.Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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327 participants in 2 patient groups

Intervention group patients will receive anticoagulation management via MTM model

Experimental group

Treatment:

Behavioral: Medication Therapy Management (MTM) model

Control group patients will be managed using a standard care.

No Intervention group