Clinical trial NCT06998745: The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients
Official title: The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thrombosis, Venous
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinically Important Medication Errors (CIME) related to anticoagulant therapy
timeFrame: From the time of the patient's admission to 6 months after discharge.
Secondary outcomes:
measure: Preventable adverse drug events (ADEs)
timeFrame: From the time of the patient's admission to 6 months after discharge.
measure: Ameliorable adverse drug events (ADEs)
timeFrame: From the time of the patient's admission to 6 months after discharge.
measure: Potential adverse drug events (ADEs)
timeFrame: From the time of the patient's admission to 6 months after discharge.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: xiaoyan li
role: PRINCIPAL_INVESTIGATOR
References: