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Pharmacist Interventions in Rural Elderly Warfarin Patients

Primary Purpose

Atrial Fibrillation, Thrombosis, Cardiac Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anticoagulation care
Sponsored by
Slaven Falamić
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring pharmacist interventions, warfarin, elderly rural patients

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Specific pharmacist-led anticoagulation care

    The control group will receive usual care; no interventions will be administered.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    July 4, 2017
    Last Updated
    July 6, 2017
    Sponsor
    Slaven Falamić
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03212898
    Brief Title
    Pharmacist Interventions in Rural Elderly Warfarin Patients
    Official Title
    The Influence of Pharmacist Interventions on the Effectiveness of Warfarin Treatment in Elderly Patients From Rural Areas
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Slaven Falamić

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Thrombosis, Cardiac Failure, Hemorrhage
    Keywords
    pharmacist interventions, warfarin, elderly rural patients

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    131 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Specific pharmacist-led anticoagulation care
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The control group will receive usual care; no interventions will be administered.
    Intervention Type
    Other
    Intervention Name(s)
    anticoagulation care
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Time in therapeutic range (TTR)
    Description
    Time in therapeutic range by Rosendaal method (percentage of time in therapeutic range)
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Adverse drug reactions
    Description
    To measure the difference in number and types of adverse drug reactions between the intervention and the control group
    Time Frame
    6 months
    Title
    Time to adverse drug reaction
    Description
    To measure the difference in time to adverse drug reactions between the intervention and the control group
    Time Frame
    6 months
    Title
    International randomised ratio
    Description
    To measure the difference in patterns of the International randomised ratio between the intervention and the control group
    Time Frame
    6 months
    Title
    Adherence
    Description
    To measure the difference in adherence between the intervention and the control group
    Time Frame
    6 months
    Title
    Quality of life
    Description
    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
    Title
    Incidence and influence of clinically significant drug interactions
    Description
    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
    Time Frame
    6 months
    Title
    Dietary intake of vitamin K
    Description
    Changes of dietary intake of vitamin K
    Time Frame
    6 months
    Title
    Acceptance of pharmacist's intervention by the general practitioners
    Description
    To measure the rate of acceptance of pharmacist's interventions by the general practitioners
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Slaven Falamić, MPharm
    Organizational Affiliation
    Pharmacy Branka Marušić
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34754004
    Citation
    Falamic S, Lucijanic M, Ortner-Hadziabdic M, Marusic S, Bacic-Vrca V. Pharmacists' interventions improve health-related quality of life of rural older person on warfarin: a randomized controlled trial. Sci Rep. 2021 Nov 9;11(1):21897. doi: 10.1038/s41598-021-01394-0.
    Results Reference
    derived

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