Clinical trial NCT03154489: Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care
Official title: Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulant
Pharmacogenetics
Community Pharmacy Services
Drug Utilization Review
Medication Therapy Management
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2017-05-16
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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..


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of medication review with follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life related to health
timeFrame: 6 months
measure: Study of patients habits
timeFrame: 6 months
measure: Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient
timeFrame: 6 months
measure: Satisfaction in primary care professionals
timeFrame: 6 months
measure: Review of clinical guidelines used in primary care
timeFrame: 6 months
measure: Economic outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Centro de Salud Arrabal
Study officials:
References: