Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 5106555, China
Location status: Recruiting
NCT Number: NCT06998745
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 5106555, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1.Participation in this study required active anticoagulant treatment. Apart from this, there were no specific exclusion criteria.
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
Time frame: From the time of the patient's admission to 6 months after discharge.
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.
Time frame: From the time of the patient's admission to 6 months after discharge.
Preventable ADEs are drug-related injuries associated with medication errors
Time frame: From the time of the patient's admission to 6 months after discharge.
Although some ADEs may not be entirely preventable, their duration or severity can be reduced, and are thus termed ameliorable ADEs.
Time frame: From the time of the patient's admission to 6 months after discharge.
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.
Contact information is provided by the study sponsor or research team.
Sixth Affiliated Hospital, Sun Yat-sen University
Other
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