Recruiting NCT06998745

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

No phase Interventional Thrombosis, Venous

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Medication Therapy Management (MTM) model.
Who it may be relevant to: Registry conditions: Thrombosis, Venous. Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

Behavioral 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

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Prevention

Study locations

China · 1 center

Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou

Publications

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

Identifiers

NCT: NCT06998745 · 2024ZSLYEC-572

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗