Chronic DiseaseNCT04556786
A Pharmacist-led Transitions of Care Program
A study testing Transitions of care in people with Chronic Disease, run by Auburn University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Transitions of care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2018to 16 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years old or older
- Uninsured
- English speaking
- Discharged from East Alabama Medical Center within the past 16 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Disease
- Being tested
- Transitions of care
- Keywords
- Transitions of care, Indigent population, Hospital readmission rates
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitions of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Transitions of care | Experimental | 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. Receives: Behavioral: Transitions of care |
| Usual care | No intervention | The study participants in this arm received usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day hospital readmission
Whether a study participant had any hospital readmission 30-day post-discharge
Measured: 30-day post-discharge
Secondary outcomes (6)
60-day hospital readmission
Whether a study participant had any hospital readmission 60-day post-discharge
Measured: 60-day post-discharge
90-day hospital readmission
Whether a study participant had any hospital readmission 90-day post-discharge
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30-day post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start2 Oct 2018
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiahung Chou, Ph.D., Auburn University
- Investigators
- Chiahung Chou, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556786
- Sponsor's protocol ID
- 18-342 EX 1809
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22411913Hawes 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.
PubMed 24327590Crotty 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.
PubMed 15903284Phatak 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.
PubMed 26434752
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Pharmacist-Led Transitional Care Program on Health Outcomes of Uninsured Populations
- ClinicalTrials.gov ID
- NCT04556786
- Acronym / sponsor ID
- 18-342 EX 1809
- Conditions
- Chronic Disease
- Keywords
- Transitions of care, Indigent population, Hospital readmission rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transitions of care | Experimental | Behavioral: Transitions of careThe 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. |
| Usual care | No intervention | –The study participants in this arm received usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years old or older
- Uninsured
- English speaking
- Discharged from East Alabama Medical Center within the past 16 days
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitions of careThe 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. | Behavioural | Transitions of care |
Primary outcome
30-day hospital readmission
Time frame: 30-day post-discharge
Whether a study participant had any hospital readmission 30-day post-discharge
6 secondary outcomes
60-day hospital readmission
Time frame: 60-day post-discharge
90-day hospital readmission
Time frame: 90-day post-discharge
30-day emergency department (ED) visit
Time frame: 30-day post-discharge
60-day emergency department (ED) visit
Time frame: 60-day post-discharge
90-day emergency department (ED) visit
Time frame: 90-day post-discharge
30-day follow-up visit with a primary care provider
Time frame: 30-day post-discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 22411913Englander 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.
- Background: PubMed 24327590Hawes 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.
- Background: PubMed 15903284Crotty 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.
- Background: PubMed 26434752Phatak 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.
- Key Facts about the Uninsured PopulationLink provided by the sponsor.
- America's Health RankingsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiahung Chou, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitions of care in people with Chronic Disease, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day hospital readmission (time frame: 30-day post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556786, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.