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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group patients will receive anticoagulation management via MTM model | Experimental |
| |
| Control group patients will be managed using a standard care. | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Therapy Management (MTM) model | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Important Medication Errors (CIME) related to anticoagulant therapy | The primary outcome is CIME related to anticoagulation therapy, which constitute a composite endpoint comprising preventable or ameliorable adverse drug events (ADEs) and potential ADEs arising from medication discrepancies or non-adherence. The primary anticoagulant-related ADEs that this trial plans to observe encompass two categories: (i) ADEs associated with the therapeutic effects of anticoagulant, including all-cause mortality, suspected recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE), confirmed symptomatic or incidental DVT, and confirmed symptomatic or incidental PE; (ii) ADEs related to the major adverse drug reactions, such as major bleeding, clinical related non-major bleeding, and minor bleeding. | From the time of the patient's admission to 6 months after discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Preventable adverse drug events (ADEs) | Preventable ADEs are drug-related injuries associated with medication errors | From the time of the patient's admission to 6 months after discharge. |
| Ameliorable adverse drug events (ADEs) |
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Inclusion Criteria:
Exclusion Criteria:
1.Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaoyan li | Contact | 13609066172 | lixyan5@mail.sysu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| xiaoyan li | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 5106555 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41797454 | Derived | 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. |
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D054539 | Medication Therapy Management |
| C099588 | myotubularin |
| D008954 | Models, Biological |
| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
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Although some ADEs may not be entirely preventable, their duration or severity can be reduced, and are thus termed ameliorable ADEs.
| From the time of the patient's admission to 6 months after discharge. |
| Potential adverse drug events (ADEs) | There are other medication-related issues that may arise after discharge, known as potential ADEs, although these situations have not yet caused any harm to patients, if left untreated, they could lead to future harm. | From the time of the patient's admission to 6 months after discharge. |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D008962 | Models, Theoretical |
| D008919 | Investigative Techniques |