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PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program

Primary Purpose

Disease, Chronic

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Usual Care
PharmD TOC
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • - Admission LACE Score: in moderate range (5 to 9) And
  • Taking high risk medication(s): anticoagulants, insulin, oral antiplatelet agents, oral hypoglycemic agents, opioid analgesics, digoxin Or Taking at least 5 medications AND have one of following: CHF, COPD, Asthma, Pneumonia, Diabetes, ESRD, Schizophrenia, Bi-Polar, Dizziness, History of Falls

And

  • Medical or Surgical Unit patients
  • Age > 18 years
  • Being discharged to home (with or without Home Health services)
  • English and/or Spanish speaking
  • Will have access to a telephone post-discharge
  • Ability to give consent
  • Patient admitted to hospital through the emergency department, as a direct admission or as a transfer, or as an elective surgery patient

Exclusion Criteria:

  • - Patients with observation status
  • Caremore Health Plan patients (Caremore has a separate post-discharge program)
  • Patients discharged and followed up by the PIH Coumadin Clinic
  • Patients discharged to Residential MD House Calls program
  • Patients discharged to Skilled Nursing Facility
  • Anyone with planned readmissions
  • Obstetrics patients
  • Hospice patients
  • Oncology patients
  • Anyone who does not meet provisions of protocol
  • Anyone unwilling or unable to give consent for study procedures and data access

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    PHARMD-TOC i

    USUAL CARE

    Arm Description

    PharmD Follow-Up Post Discharge

    Usual Post Discharge Procedures

    Outcomes

    Primary Outcome Measures

    Proportion Patients with Hospital Reutilization
    proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge

    Secondary Outcome Measures

    Full Information

    First Posted
    July 31, 2018
    Last Updated
    February 10, 2020
    Sponsor
    University of California, San Diego
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03617380
    Brief Title
    PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program
    Official Title
    PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    transferred to different institution
    Study Start Date
    October 1, 2018 (Actual)
    Primary Completion Date
    February 10, 2020 (Actual)
    Study Completion Date
    February 10, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego

    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
    Many hospitals and medical groups have developed transitions of care (TOC) programs or procedures in an attempt to reduce hospital readmission and reutilization rates of patients discharged from the hospital. As healthcare's most accessible practitioners, Community Pharmacists have a unique opportunity to assist with reducing unnecessary hospital re-utilization (re-admissions and emergency department visits) after hospital discharge. The purpose of this study is to conduct and evaluate the implementation of a Community Pharmacy-based Transitions of Care (TOC) Program for high-risk post-discharge patients of PIH Health Hospital-Whittier (PIH). The primary objective will be to compare the proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge between patients randomly assigned to the PHARMD-TOC group vs. the historic rate at PIH. Secondary analyses will examine differences between groups and describe implementation details of the PHARMD-TOC model of patient care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disease, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PHARMD-TOC i
    Arm Type
    Experimental
    Arm Description
    PharmD Follow-Up Post Discharge
    Arm Title
    USUAL CARE
    Arm Type
    Active Comparator
    Arm Description
    Usual Post Discharge Procedures
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    patients participating Usual Care discharge services
    Intervention Type
    Other
    Intervention Name(s)
    PharmD TOC
    Intervention Description
    patients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC)
    Primary Outcome Measure Information:
    Title
    Proportion Patients with Hospital Reutilization
    Description
    proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge
    Time Frame
    30 days post hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Admission LACE Score: in moderate range (5 to 9) And Taking high risk medication(s): anticoagulants, insulin, oral antiplatelet agents, oral hypoglycemic agents, opioid analgesics, digoxin Or Taking at least 5 medications AND have one of following: CHF, COPD, Asthma, Pneumonia, Diabetes, ESRD, Schizophrenia, Bi-Polar, Dizziness, History of Falls And Medical or Surgical Unit patients Age > 18 years Being discharged to home (with or without Home Health services) English and/or Spanish speaking Will have access to a telephone post-discharge Ability to give consent Patient admitted to hospital through the emergency department, as a direct admission or as a transfer, or as an elective surgery patient Exclusion Criteria: - Patients with observation status Caremore Health Plan patients (Caremore has a separate post-discharge program) Patients discharged and followed up by the PIH Coumadin Clinic Patients discharged to Residential MD House Calls program Patients discharged to Skilled Nursing Facility Anyone with planned readmissions Obstetrics patients Hospice patients Oncology patients Anyone who does not meet provisions of protocol Anyone unwilling or unable to give consent for study procedures and data access

    12. IPD Sharing Statement

    Learn more about this trial

    PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program

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