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

NCT03154489 | Completed

• 1 other identifier: 914913001
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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..

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Quality of life related to health

  6 months

• Study of patients habits

  6 months

• Pharmacogenetic analysis of genes CYP2C9 and VKORC1, ApoE CYP4F2 in each patient

  6 months

• Satisfaction in primary care professionals

  6 months

• Review of clinical guidelines used in primary care

  6 months

Study Arms (2)

Acenocoumarol

OTHER

Other: acenocoumarol

control group

OTHER

Other: control

Interventions

acenocoumarol OTHER

medication review with follow-up in acenocoumarol treatment

Acenocoumarol

control OTHER

group

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad San Jorge: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Centro de Salud Arrabal

Zaragoza, 50015, Spain

Location

Related Publications (1)

• Saez-Benito A, Berenguer N, Magallon R, Olivan B, Ezquerra L, Saez-Benito L. Clinical, economic, and humanistic impact of a multidisciplinary medication review with follow-up for anticoagulated patients treated with vitamin K antagonists in primary care: A cluster randomised controlled trial. Res Social Adm Pharm. 2023 Dec;19(12):1570-1578. doi: 10.1016/j.sapharm.2023.08.007. Epub 2023 Aug 26.

  PMID: 37704534 DERIVED

MeSH Terms

Interventions

Acenocoumarol

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 16, 2017
• Study Start: May 22, 2017
• Primary Completion: January 22, 2019
• Study Completion: September 22, 2019
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)