A Pharmacist-led Transitions of Care Program
Primary Purpose
Chronic Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transitions of care
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Disease focused on measuring Transitions of care, Indigent population, Hospital readmission rates
Eligibility Criteria
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
Sites / Locations
- Mercy Medical Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transitions of care
Usual care
Arm Description
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 study participants in this arm received usual care.
Outcomes
Primary Outcome Measures
30-day hospital readmission
Whether a study participant had any hospital readmission 30-day post-discharge
Secondary Outcome Measures
60-day hospital readmission
Whether a study participant had any hospital readmission 60-day post-discharge
90-day hospital readmission
Whether a study participant had any hospital readmission 90-day post-discharge
30-day emergency department (ED) visit
Number of ED visits among study participants in each study arm 30-day post-discharge
60-day emergency department (ED) visit
Number of ED visits among study participants in each study arm 60-day post-discharge
90-day emergency department (ED) visit
Number of ED visits among study participants in each study arm 90-day post-discharge
30-day follow-up visit with a primary care provider
Did a study participant keep a follow-up appointment with a primary care provider
Full Information
NCT ID
NCT04556786
First Posted
September 15, 2020
Last Updated
September 18, 2020
Sponsor
Auburn University
1. Study Identification
Unique Protocol Identification Number
NCT04556786
Brief Title
A Pharmacist-led Transitions of Care Program
Official Title
The Impact of a Pharmacist-Led Transitional Care Program on Health Outcomes of Uninsured Populations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Transitions of care, Indigent population, Hospital readmission rates
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transitions of care
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The study participants in this arm received usual care.
Intervention Type
Behavioral
Intervention Name(s)
Transitions of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
30-day hospital readmission
Description
Whether a study participant had any hospital readmission 30-day post-discharge
Time Frame
30-day post-discharge
Secondary Outcome Measure Information:
Title
60-day hospital readmission
Description
Whether a study participant had any hospital readmission 60-day post-discharge
Time Frame
60-day post-discharge
Title
90-day hospital readmission
Description
Whether a study participant had any hospital readmission 90-day post-discharge
Time Frame
90-day post-discharge
Title
30-day emergency department (ED) visit
Description
Number of ED visits among study participants in each study arm 30-day post-discharge
Time Frame
30-day post-discharge
Title
60-day emergency department (ED) visit
Description
Number of ED visits among study participants in each study arm 60-day post-discharge
Time Frame
60-day post-discharge
Title
90-day emergency department (ED) visit
Description
Number of ED visits among study participants in each study arm 90-day post-discharge
Time Frame
90-day post-discharge
Title
30-day follow-up visit with a primary care provider
Description
Did a study participant keep a follow-up appointment with a primary care provider
Time Frame
30-day post-discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chiahung Chou, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Medical Clinic
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36830
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22411913
Citation
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.
Results Reference
background
PubMed Identifier
24327590
Citation
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.
Results Reference
background
PubMed Identifier
15903284
Citation
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.
Results Reference
background
PubMed Identifier
26434752
Citation
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.
Results Reference
background
Links:
URL
http://files.kff.org/attachment/Fact-Sheet-Key-Facts-about-the-Uninsured-Population
Description
Key Facts about the Uninsured Population
URL
https://assets.americashealthrankings.org/app/uploads/ahrannual17_complete-121817.pdf
Description
America's Health Rankings
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A Pharmacist-led Transitions of Care Program
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