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Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization

Primary Purpose

Adverse Drug Events

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medication reconciliation intervention
Sponsored by
Sultan Qaboos University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adverse Drug Events focused on measuring adverse drug events, preventable, potential, counselling, medication reconciliation

Eligibility Criteria

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

Inclusion Criteria:

  • admitted to one of the two medical wards, male and female medical wards.
  • was on at least one medication prior to admission
  • spoke Arabic or English and can be (the patient or care giver) interviewed for medication history
  • stayed in the hospital for at least 24 hours
  • discharged on at least one chronic medication or is at least on one chronic medication even if not prescribed upon discharge

Exclusion Criteria:

  • could not be interviewed due to language barrier, impaired cognition or other reasons and did not have a care giver
  • was under specialties other than medical specialties, but was admitted to medical wards because of lack of beds in their respective wards
  • was pregnant
  • was already included in the study at a previous admission
  • left the hospital against medical advice
  • with length of stay of >60 days.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    medication reconciliation intervention

    usual care

    Arm Description

    medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list

    Usual care provided by ward pharmacist, nurses and doctors in the ward

    Outcomes

    Primary Outcome Measures

    number of patients with a preventable adverse drug event
    number of potential adverse drug events

    Secondary Outcome Measures

    number of emergency room visits
    number of unplanned hospital visits
    number of hospital readmissions
    number of patients who traveled abroad to seek second medical opinion

    Full Information

    First Posted
    June 15, 2016
    Last Updated
    June 20, 2016
    Sponsor
    Sultan Qaboos University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02805270
    Brief Title
    Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization
    Official Title
    Implementation of a Medication Reconciliation Intervention and Its Impact on the Rate of ADEs and Healthcare Utilization 30 Days Following Discharge From the Hospital. A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sultan Qaboos University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The implementation of a medication reconciliation intervention including: medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list, on the development of adverse drug events within 30 days post discharge as primary outcome. Secondary outcome is the evaluation of its impact on health care resource utilization
    Detailed Description
    This is a randomized controlled trial in 587 patients randomized to intervention and usual care. The intervention is medication reconciliation on admission and discharge, bedside medication counselling and take-home medication list. Usual care is ward pharmacy practice. The primary outcomes are preventable and potential adverse drug events at 30 days post discharge. The secondary outcome is health care utilization: length of stay, emergency room visits, unplanned hospital visits, readmissions and travel abroad to seek medical attention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adverse Drug Events
    Keywords
    adverse drug events, preventable, potential, counselling, medication reconciliation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    587 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    medication reconciliation intervention
    Arm Type
    Experimental
    Arm Description
    medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    Usual care provided by ward pharmacist, nurses and doctors in the ward
    Intervention Type
    Other
    Intervention Name(s)
    medication reconciliation intervention
    Intervention Description
    medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
    Primary Outcome Measure Information:
    Title
    number of patients with a preventable adverse drug event
    Time Frame
    30 days
    Title
    number of potential adverse drug events
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    number of emergency room visits
    Time Frame
    30 days
    Title
    number of unplanned hospital visits
    Time Frame
    30 days
    Title
    number of hospital readmissions
    Time Frame
    30 days
    Title
    number of patients who traveled abroad to seek second medical opinion
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: admitted to one of the two medical wards, male and female medical wards. was on at least one medication prior to admission spoke Arabic or English and can be (the patient or care giver) interviewed for medication history stayed in the hospital for at least 24 hours discharged on at least one chronic medication or is at least on one chronic medication even if not prescribed upon discharge Exclusion Criteria: could not be interviewed due to language barrier, impaired cognition or other reasons and did not have a care giver was under specialties other than medical specialties, but was admitted to medical wards because of lack of beds in their respective wards was pregnant was already included in the study at a previous admission left the hospital against medical advice with length of stay of >60 days.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amna Al-Hashar, PhD candidate
    Organizational Affiliation
    Sultan Qaboos University College of Medicine and Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16534045
    Citation
    Schnipper JL, Kirwin JL, Cotugno MC, Wahlstrom SA, Brown BA, Tarvin E, Kachalia A, Horng M, Roy CL, McKean SC, Bates DW. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006 Mar 13;166(5):565-71. doi: 10.1001/archinte.166.5.565.
    Results Reference
    background
    PubMed Identifier
    22751755
    Citation
    Kripalani S, Roumie CL, Dalal AK, Cawthon C, Businger A, Eden SK, Shintani A, Sponsler KC, Harris LJ, Theobald C, Huang RL, Scheurer D, Hunt S, Jacobson TA, Rask KJ, Vaccarino V, Gandhi TK, Bates DW, Williams MV, Schnipper JL; PILL-CVD (Pharmacist Intervention for Low Literacy in Cardiovascular Disease) Study Group. Effect of a pharmacist intervention on clinically important medication errors after hospital discharge: a randomized trial. Ann Intern Med. 2012 Jul 3;157(1):1-10. doi: 10.7326/0003-4819-157-1-201207030-00003.
    Results Reference
    background

    Learn more about this trial

    Impact of Medication Reconciliation Intervention on the Rate of Preventable Adverse Drug Events (ADEs) and Healthcare Utilization

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