Thrombosis, Venous
Conditions
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.
Interventions
BEHAVIORALMedication 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
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Important Medication Errors (CIME) related to anticoagulant therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preventable adverse drug events (ADEs) | From the time of the patient's admission to 6 months after discharge. | Preventable ADEs are drug-related injuries associated with medication errors |
| Ameliorable adverse drug events (ADEs) | 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. |
| Potential adverse drug events (ADEs) | 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. |
Countries
China
Contacts
Primary Contactxiaoyan li
Outcome results
None listed