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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorSixth Affiliated Hospital, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

327 Participants
are divided into 2 treatment groups
Group A: Intervention group patients will receive anticoagulation management via MTM modelExperimental treatment 1 intervention
Group B: Control group patients will be managed using a standard care.No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From the time of the patient's admission to 6 months after discharge.

Secondary outcomes

1

Preventable adverse drug events (ADEs)

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.
2

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.

Time frame
From the time of the patient's admission to 6 months after discharge.
3

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.

Time frame
From the time of the patient's admission to 6 months after discharge.

Other outcomes

Sponsors and contacts

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