- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03617380
PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program
February 10, 2020 updated by: Candi Morello, University of California, San Diego
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PHARMD-TOC i
PharmD Follow-Up Post Discharge
|
patients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC)
|
|
Active Comparator: USUAL CARE
Usual Post Discharge Procedures
|
patients participating Usual Care discharge services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion Patients with Hospital Reutilization
Time Frame: 30 days post hospital discharge
|
proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge
|
30 days post hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
February 10, 2020
Study Completion (Actual)
February 10, 2020
Study Registration Dates
First Submitted
July 31, 2018
First Submitted That Met QC Criteria
July 31, 2018
First Posted (Actual)
August 6, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171847
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.