Pharmacist Interventions in Rural Elderly Warfarin Patients

Overview

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

Full Title of Study: “The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: January 2017

Interventions

  • Other: anticoagulation care
    • 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

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Specific pharmacist-led anticoagulation care
  • No Intervention: Control
    • The control group will receive usual care; no interventions will be administered.

Clinical Trial Outcome Measures

Primary Measures

  • Time in therapeutic range (TTR)
    • Time Frame: 6 months
    • Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Slaven Falamić
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Slaven Falamić, Slaven Falamić,MPharm, Prinicipal-Investigator – Slaven Falamić
  • Overall Official(s)
    • Slaven Falamić, MPharm, Principal Investigator, Pharmacy Branka Marušić

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