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

Not Applicable

Completed

• Conditions: Anticoagulant; Pharmacogenetics; Community Pharmacy Services; Medication Therapy Management; Drug Utilization Review
• Interventions: Other: acenocoumarol; Other: control

• Registration Number: NCT03154489
• Lead Sponsor: Universidad San Jorge

Brief 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..

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Study Start: 2017-05-22
• Primary Completion: 2019-01-22
• Study Completion: 2019-09-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acenocoumarol	acenocoumarol	-
control group	control	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of medication review with follow-up	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life related to health	6 months	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.
Study of patients habits	6 months	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.
Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient	6 months	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.
Satisfaction in primary care professionals	6 months	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
Review of clinical guidelines used in primary care	6 months	Assess therapeutic appropriateness of coumarins anticoagulants in relation to clinical practice guidelines used actually.
Economic outcomes	6 months	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.

Trial Locations

Locations (1)

Centro de Salud Arrabal; 🇪🇸 Zaragoza, Spain