About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Medication Therapy Management (MTM) model
BehavioralMTM model comprising five core elements: Medication Therapy Review (MTR), Personal Medication Record (PMR), Medication-Related Action Plan (MAP), interventions \& referrals, and documentation \& follow-up
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Preventable adverse drug events (ADEs)
Preventable ADEs are drug-related injuries associated with medication errors
Ameliorable adverse drug events (ADEs)
Although some ADEs may not be entirely preventable, their duration or severity can be reduced, and are thus termed ameliorable ADEs.
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.
Sponsors and contacts
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