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Effect of pharmacy-led medication reconciliation in the elderly patients

Status Approved

  • First Submitted Date

    2021/02/16

  • Registered Date

    2021/03/12

  • Last Updated Date

    2021/02/16

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005994
    Unique Protocol ID 2020-06-029
    Public/Brief Title Effect of pharmacy-led medication reconciliation in the elderly patients
    Scientific Title Effect of pharmacy-led medication reconciliation in the elderly patients
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-06-029
    Approval Date 2020-07-13
    Institutional Review Board Name Inha University Hospital,Institutional Review Board
    Institutional Review Board Address 27, Inhang-ro, Jung-gu, Incheon
    Institutional Review Board Telephone 032-890-3691
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Jung Hwan LEE
    Title Clinical professor
    Telephone +82-32-890-3557
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon
    Contact Person for Public Queries
    Name Sunmin LEE
    Title Pharmacist
    Telephone +82-32-890-3311
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon
    Contact Person for Updating Information
    Name Sunmin LEE
    Title Pharmacits
    Telephone +82-32-890-3311
    Affiliation Inha University Hospital
    Address 27, Inhang-ro, Jung-gu, Incheon
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2020-07-21 Actual
    Target Number of Participant 140
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2020-07-21 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Inha University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inha University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study is an open-label, randomized controlled trial evaluating the effectiveness of multidisciplinary drug intervention in hospitalized elderly patients with chronic diseases. This study consists of an investigation through an interview with a pharmacist within 24 hours in the hospital medicine ward, drug intervention activities during hospitalization, and an investigation through an interview with a pharmacist 30 days after discharge.
    1) Interview within 24 hours after admission 
    (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed
    2) Pharmacist prescription intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention
    2)Pharmacist's prescription intervention activity at discharge: Reduction of rigimen complexity (simplification of usage, matching of medication time)
    3) 30 days after discharge, re-evaluation of the survey index and self-report ADE(Adverse drug event)
    4) Continuous ADE(Adverse drug event) confirmation at hospitalization and evaluation of correlation with drug intervention activities
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
     Health Services Research
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Others (Pharmacist service)
    Intervention Description
    1) Interview within 24 hours after admission 
    (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed
    2) Pharmacist medication intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention
    2)Pharmacist's prescription intervention activity at discharge: Reduction of regimen complexity (simplification of usage, matching of medication time)
    Number of Arms 2
    Arm 1

    Arm Label

    Pharmacist intervention group

    Target Number of Participant

    70

    Arm Type

    Experimental

    Arm Description

    1) Interview within 24 hours after admission 
    (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed
    2) Pharmacist prescription intervention activities at hospitalization: adjustment of renal function dose, confirmation of drug interaction, inappropriate prescription intervention
    3)Pharmacist's prescription intervention activity at discharge: Reduction of regimen complexity (simplification of usage, matching of medication time)
    Arm 2

    Arm Label

    Pharmacist No intervention group

    Target Number of Participant

    70

    Arm Type

    No intervention

    Arm Description

    1) Interview within 24 hours after admission 
    (Comprehensive documentation of medication history, assessment of patient's usual medication status: MMAS-4 (Morisky medication adherence scale 4 item): Medication compliance, MAI (Medication Appropriateness Index): Assessment of prescription adequacy through overall medication assessment, MRCI- K (Korean version of Medication regimen complexity index): Assessment of prescription complexity, potentially inappropriate medications (PIMs): BEER 2019, STOPP 2015, START 2015 confirmed
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Education 

    Polypharmacy
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    Hospitalized in the Department of hospital Medicine (including those who come from the intensive care unit) Senior patients 65 years of age or older who are receiving five or more drug therapy (polypharmacy) for a comorbid disease
    • Those who agree to participate in the research among elderly patients 65 years of age or older who were admitted to the Department of hospital Medicine at Inha University Hospital from August 2020 to February 2021
    • Patients with self-communication during hospitalization or good communication with a care giver
    • Those who can communicate over the phone for more than 30 days after discharge or those who can communicate with a care giver
    Exclusion Criteria
    • Those who do not agree to participate in the research
    • Those whose life expectancy is less than 3 months
    • Patients discharged within 24 hours
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    The difference of adverse events reported in the control and intervention groups
    Timepoint
    Continuous evaluation during hospitalization, evaluation by phone 30 days after discharge
    Secondary Outcome(s) 1
    Outcome
    Intervention index score change after hospitalization period, readmission, discharge, 30 days after discharge (reduction in number of MRCI-K, MAI, MMAS-4, PIMS), decrease in polypharmacy, change in the expression of adverse drug reactions
    Timepoint
    Assessment at discharge, evaluation by phone 30 days after discharge
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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