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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Medication Therapy Management (MTM) model
  MTM model comprising five core elements: Medication Therapy Review (MTR), Personal Medication Record (PMR), Medication-Related Action Plan (MAP), interventions \& referrals, and documentation \& follow-up

Первичные конечные точки

• Clinically Important Medication Errors (CIME) related to anticoagulant therapy [Срок оценки: From the time of the patient's admission to 6 months after discharge.]

Вторичные конечные точки (3)

• Preventable adverse drug events (ADEs) [Срок оценки: From the time of the patient's admission to 6 months after discharge.]
• Ameliorable adverse drug events (ADEs) [Срок оценки: From the time of the patient's admission to 6 months after discharge.]
• Potential adverse drug events (ADEs) [Срок оценки: From the time of the patient's admission to 6 months after discharge.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sixth Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Публикации

• Mao J, Liang Z, Gao M, Huang X, Xie J, Dai C, Zhao J, Ding Y, Ye G, Wang Y, Qin L, Li X. Protocol for the impact of medication therapy management on efficacy and safety of postoperative anticoagulation therapy in patients with colorectal cancer: an open-label, prospective and randomized clinical trial. Chin Clin Oncol. 2026 Feb;15(1):6. doi: 10.21037/cco-25-111. PMID 41797454

Идентификаторы

NCT: NCT06998745 · 2024ZSLYEC-572

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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