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

NCT ID: NCT03154489

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2019-09-22

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Acenocoumarol

Group Type: OTHER

acenocoumarol

Intervention Type: OTHER

medication review with follow-up in acenocoumarol treatment

control group

Group Type: OTHER

control

Intervention Type: OTHER

group

Interventions

acenocoumarol

medication review with follow-up in acenocoumarol treatment

Intervention Type: OTHER

control

group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro de Salud Arrabal

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 37704534 (View on PubMed)

Other Identifiers

914913001

Identifier Type: -

Identifier Source: org_study_id