Pharmacist Interventions in Rural Elderly Warfarin Patients

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Thrombosis; Hemorrhage; Cardiac Failure
• Interventions: Other: anticoagulation care

• Registration Number: NCT03212898
• Lead Sponsor: Slaven Falamić

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-06
• Last Update Submitted: 2017-07-06
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	anticoagulation care	Specific pharmacist-led anticoagulation care

Primary Outcome Measures

Name	Time	Method
Time in therapeutic range (TTR)	6 months	Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)

Secondary Outcome Measures

Name	Time	Method
Adverse drug reactions	6 months	To measure the difference in number and types of adverse drug reactions between the intervention and the control group
Adherence	6 months	To measure the difference in adherence between the intervention and the control group
International randomised ratio	6 months	To measure the difference in patterns of the International randomised ratio between the intervention and the control group
Quality of life	6 months	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)
Acceptance of pharmacist's intervention by the general practitioners	6 months	To measure the rate of acceptance of pharmacist's interventions by the general practitioners
Time to adverse drug reaction	6 months	To measure the difference in time to adverse drug reactions between the intervention and the control group
Dietary intake of vitamin K	6 months	Changes of dietary intake of vitamin K
Incidence and influence of clinically significant drug interactions	6 months	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