The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients
Led by Sixth Affiliated Hospital, Sun Yat-sen University ยท Updated on 2025-05-31
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What this Trial Is About
Researchers are studying the impact of the Medication Therapy Management (MTM) model on the safety and effectiveness of anticoagulant therapy in patients who have undergone surgery for colorectal cancer (CRC). These patients often face a high risk of recurrent venous thromboembolism (VTE) and bleeding events due to anticoagulant use. The study aims to reduce adverse drug events by improving management of anticoagulant therapy through pharmacist-led interventions.
The study compares two groups: one receiving anticoagulation management using the MTM model, which includes medication review, personal medication records, action plans, interventions, referrals, and follow-up, and the other receiving standard care without these structured interventions. The MTM interventions occur at patient admission, during hospitalization, and after discharge to provide continuous medication management.
Participants will be monitored from admission through six months after discharge. Researchers will assess medication errors related to anticoagulant therapy as the primary outcome, along with preventable, ameliorable, and potential adverse drug events. The study involves randomized assignment to groups and includes single masking. The total follow-up period for each participant is six months after hospital discharge to evaluate safety and efficacy outcomes comprehensively.
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Brief Title
The Impact of MTM Model on the Efficacy and Safety of Anticoagulant Therapy in Postoperative Colorectal Cancer Patients
Who Can Participate
Age: 18Years - 100Years
All Genders
Eligibility Criteria
You may qualify if you...
Patients with histologically confirmed colorectal cancer (CRC) and symptomatic or incidental venous thromboembolism (VTE) who received anticoagulant treatment
CRC patients with VTE treated with an anticoagulant for at least 3 months
Adults aged 18 to 100 years
Active anticoagulant treatment during the study period
You will not qualify if you...
No specific exclusion criteria other than requiring active anticoagulant treatment
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Inpatient Treatment
Duration - From admission until discharge
Participants receive pharmacist-led anticoagulation management based on the Medication Therapy Management (MTM) model during their hospital stay after colorectal cancer surgery.
Visits during hospitalization as part of routine care
Outpatient Treatment
Duration - Up to 6 months after discharge
Participants continue anticoagulation management and monitoring through the MTM model after hospital discharge.
Regular outpatient visits for medication review and follow-up
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.