- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04556786
A Pharmacist-led Transitions of Care Program
September 18, 2020 updated by: Chiahung Chou, Ph.D., Auburn University
The Impact of a Pharmacist-Led Transitional Care Program on Health Outcomes of Uninsured Populations
This study was to show the value of pharmacists in providing transitions of care to and improving health outcomes of uninsured populations.
It also aimed to demonstrate the feasibility of implementing a transitions of care program in an indigent care clinic with limited resources.
We hypothesized that a pharmacist-led transitions of care program will reduce 30-day hospital readmission rates among the uninsured discharged from a community hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Auburn, Alabama, United States, 36830
- Mercy Medical Clinic
-
-
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:
- Aged 18 years old or older
- Uninsured
- English speaking
- Discharged from East Alabama Medical Center within the past 16 days
Exclusion Criteria:
- Patients who did not show up for the first follow-up visit with the study pharmacist after being referred by the care coordinator at East Alabama Medical Center
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transitions of care
The study participants in this aim received usual care plus medication reconciliation, daily schedule for medication taking and medical condition monitoring, and follow-up phone calls from a pharmacist.
|
The intervention was a pharmacist-led transitions of care program that include medication reconciliation, daily schedule for medication taking and medical condition monitoring, and follow-up phone calls from a pharmacist at 60- and 90-day post-discharge in addition to the usual care.
|
|
No Intervention: Usual care
The study participants in this arm received usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-day hospital readmission
Time Frame: 30-day post-discharge
|
Whether a study participant had any hospital readmission 30-day post-discharge
|
30-day post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
60-day hospital readmission
Time Frame: 60-day post-discharge
|
Whether a study participant had any hospital readmission 60-day post-discharge
|
60-day post-discharge
|
|
90-day hospital readmission
Time Frame: 90-day post-discharge
|
Whether a study participant had any hospital readmission 90-day post-discharge
|
90-day post-discharge
|
|
30-day emergency department (ED) visit
Time Frame: 30-day post-discharge
|
Number of ED visits among study participants in each study arm 30-day post-discharge
|
30-day post-discharge
|
|
60-day emergency department (ED) visit
Time Frame: 60-day post-discharge
|
Number of ED visits among study participants in each study arm 60-day post-discharge
|
60-day post-discharge
|
|
90-day emergency department (ED) visit
Time Frame: 90-day post-discharge
|
Number of ED visits among study participants in each study arm 90-day post-discharge
|
90-day post-discharge
|
|
30-day follow-up visit with a primary care provider
Time Frame: 30-day post-discharge
|
Did a study participant keep a follow-up appointment with a primary care provider
|
30-day post-discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chiahung Chou, PhD, Auburn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Englander H, Kansagara D. Planning and designing the care transitions innovation (C-Train) for uninsured and Medicaid patients. J Hosp Med. 2012 Sep;7(7):524-9. doi: 10.1002/jhm.1926. Epub 2012 Mar 12.
- Hawes EM, Maxwell WD, White SF, Mangun J, Lin FC. Impact of an outpatient pharmacist intervention on medication discrepancies and health care resource utilization in posthospitalization care transitions. J Prim Care Community Health. 2014 Jan 1;5(1):14-8. doi: 10.1177/2150131913502489. Epub 2013 Sep 17.
- Crotty M, Rowett D, Spurling L, Giles LC, Phillips PA. Does the addition of a pharmacist transition coordinator improve evidence-based medication management and health outcomes in older adults moving from the hospital to a long-term care facility? Results of a randomized, controlled trial. Am J Geriatr Pharmacother. 2004 Dec;2(4):257-64. doi: 10.1016/j.amjopharm.2005.01.001.
- Phatak A, Prusi R, Ward B, Hansen LO, Williams MV, Vetter E, Chapman N, Postelnick M. Impact of pharmacist involvement in the transitional care of high-risk patients through medication reconciliation, medication education, and postdischarge call-backs (IPITCH Study). J Hosp Med. 2016 Jan;11(1):39-44. doi: 10.1002/jhm.2493. Epub 2015 Oct 5.
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 2, 2018
Primary Completion (Actual)
July 16, 2019
Study Completion (Actual)
July 16, 2019
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 18, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
September 21, 2020
Last Update Submitted That Met QC Criteria
September 18, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-342 EX 1809
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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