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

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..

Study Overview

• Status: Completed
• Conditions: Pharmacogenetics; Anticoagulant; Medication Therapy Management; Community Pharmacy Services; Drug Utilization Review
• Intervention / Treatment: Other: acenocoumarol; Other: control

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50015
    • Centro de Salud Arrabal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Submit a TTR less than 70% in the last 6 months.

Exclusion Criteria:

• Not sign the informed consent.
• Present cognitive difficulties for the project.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group	Other: control; group
Other: Acenocoumarol	Other: acenocoumarol; medication review with follow-up in acenocoumarol treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of medication review with follow-up	Compare the effectiveness of medication review with follow-up in collaboration with doctors and nurses of primary care patients in treatment with anticoagulants coumarins against the usual practice used actually. Principally studying INR control of this patients during 6 months.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life related to health	Evaluate the effect of specific pharmaceutical interventions (medication review with follow-up) aimed at patients in treatment with coumarin anticoagulants within the framework of medication review with follow-up quality of life related to health using validated questionnaires.	6 months
Study of patients habits	Evaluate the effect of medication review with follow-up on the adherence of the patient, eating habits in relation to the consumption of vitamin K, and their knowledge about the use of acenocoumarol by using validated questionnaires.	6 months
Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient	Analyze the clinical utility of the incorporation of additional tools like pharmacogenetic analysis of this four genes (CYP2C9 and VKORC1, ApoE CYP4F2) for clinical decision-making in patients with unstable INR. Thanks to the bibliography is known that these gene affect the individual variability of each patient to the acenocoumarol so is going to be studying patients pharmacogenetics for this four genes.	6 months
Satisfaction in primary care professionals	Evaluate the satisfaction of medical prescribers, nurses, patients and community pharmacists with the usefulness of medication review with follow-up realized by a pharmacist with focus groups	6 months
Review of clinical guidelines used in primary care	Assess therapeutic appropriateness of coumarins anticoagulants in relation to clinical practice guidelines used actually.	6 months
Economic outcomes	Evaluate the effect of specific pharmaceutical interventions (medication review with follow-up) aimed at patients in treatment with coumarin anticoagulants within the framework of medication review with follow-up. The economic outcome is going to be assess by following patients if they have admissions in hospital due to bad INR control or they need some extra visits to doctor. This cost a lot to Health System and if it can be avoided it would save costs.	6 months

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: Roche Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2017
• Primary Completion (Actual): January 22, 2019
• Study Completion (Actual): September 22, 2019

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anticoagulants; Acenocoumarol
• Other Study ID Numbers: 914913001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No