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

U

Universidad San Jorge

Status

Completed

Conditions

Medication Therapy Management
Drug Utilization Review
Anticoagulant
Pharmacogenetics
Community Pharmacy Services

Treatments

Other: acenocoumarol
Other: control

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03154489
914913001

Details and patient eligibility

About

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..

Enrollment

204 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

204 participants in 2 patient groups

Acenocoumarol
Other group
Treatment:
Other: acenocoumarol
control group
Other group
Treatment:
Other: control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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