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Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care

NCT03154489 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-05-04

No results posted yet for this study

Summary

The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..

Conditions

  • Anticoagulant
  • Pharmacogenetics
  • Community Pharmacy Services
  • Drug Utilization Review
  • Medication Therapy Management

Interventions

OTHER

acenocoumarol

medication review with follow-up in acenocoumarol treatment

OTHER

control

group

Sponsors & Collaborators

  • Roche Diagnostics GmbH

    collaborator INDUSTRY

  • Universidad San Jorge

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2019-01-22
Completion
2019-09-22

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03154489 on ClinicalTrials.gov