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

NCT06998745 | Recruiting DMC

• 1 other identifier: 2024ZSLYEC-572
• Study Type: interventional
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombosis, Venous

Outcome Measures

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.

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

Secondary Outcomes (3)

• Preventable adverse drug events (ADEs)

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

• Ameliorable adverse drug events (ADEs)

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

• Potential adverse drug events (ADEs)

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

Study Arms (2)

Intervention group patients will receive anticoagulation management via MTM model

EXPERIMENTAL

Behavioral: Medication Therapy Management (MTM) model

Control group patients will be managed using a standard care.

NO INTERVENTION

Interventions

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

Intervention group patients will receive anticoagulation management via MTM model

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 5106555, China

RECRUITING

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Medication Therapy Management; myotubularin; Models, Biological

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration; Models, Theoretical; Investigative Techniques

Study Officials

• xiaoyan li

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaoyan li

CONTACT

13609066172; lixyan5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 31, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)