Pharmacist Interventions in Rural Elderly Warfarin Patients

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

Official Title
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The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas

Conditions
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Atrial Fibrillation, Thrombosis, Cardiac Failure, Hemorrhage

Intervention / Treatment
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* Other: anticoagulation care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Specific pharmacist-led anticoagulation care | Other: anticoagulation care<br>* 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<br>|
| No Intervention: Control<br>The control group will receive usual care; no interventions will be administered. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in therapeutic range (TTR) | Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions | To measure the difference in number and types of adverse drug reactions between the intervention and the control group | 6 months | 
| Time to adverse drug reaction | To measure the difference in time to adverse drug reactions between the intervention and the control group | 6 months | 
| International randomised ratio | To measure the difference in patterns of the International randomised ratio between the intervention and the control group | 6 months | 
| Adherence | To measure the difference in adherence between the intervention and the control group | 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) | 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 | 6 months | 
| Dietary intake of vitamin K | Changes of dietary intake of vitamin K | 6 months | 
| Acceptance of pharmacist's intervention by the general practitioners | To measure the rate of acceptance of pharmacist's interventions by the general practitioners | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacist interventions, warfarin, elderly rural patients