Pharmacist Interventions in Rural Elderly Warfarin Patients

Slaven Falamić131 enrolled

Overview

The primary study goal is to explore the influence of pharmacist interventions on the effectiveness of warfarin treatment in a specific subpopulation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

131

Conditions

Atrial Fibrillation Thrombosis Cardiac Failure Hemorrhage

Interventions

anticoagulation careOTHER

Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥65 years * Living site of participant outside the city eg. rural site * Expected duration of warfarin therapy at least 6 months from the inclusion in the study and 3 months before Exclusion Criteria: * Hospitalization * Vegetarianism * Patients not able to provide an informed consent * The use of drug that has an X level of clinical significance of interaction with warfarin according to Lexicomp interact base

Outcomes

Primary Outcomes

Time in therapeutic range (TTR)

Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)

Time frame: 6 months

Secondary Outcomes

Adverse drug reactions

To measure the difference in number and types of adverse drug reactions between the intervention and the control group

Time frame: 6 months

Time to adverse drug reaction

To measure the difference in time to adverse drug reactions between the intervention and the control group

Time frame: 6 months

International randomised ratio

To measure the difference in patterns of the International randomised ratio between the intervention and the control group

Time frame: 6 months

Adherence

To measure the difference in adherence between the intervention and the control group

Time frame: 6 months

Quality of life

To measure the difference of the quality of life in the intervention and the control group at the beginning and the end of the study (validated Croatian version of DUKE - Duke anticoagulation satisfaction scale questionaire)

Time frame: 6 months

Incidence and influence of clinically significant drug interactions

To measure the incidence of clinically significant drug interactions (defined by the Lexicomp-interact base as degree C and D of clinical significance) and influence of drug interactions on the effectiveness and safety of treatment between the intervention and the control group

Data from ClinicalTrials.gov

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