- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01906645
Care Transitions Innovation (C-TraIn)
Care Transitions Innovation (C-TraIn): Study of a Multi-component Transitional Care Intervention for Uninsured and Low-income Publicly Insured Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hospitalized on one of seven inpatient treatment teams
- uninsured or low-income publicly insured (Medicaid; Medicare/Medicaid; or Medicare without supplemental insurance and ≤200% poverty level)
- reside in one of three metro-area counties (Multnomah, Washington, Clackamas)
Exclusion Criteria:
- not community dwelling (ie not from a long-term care facility or with plans to discharge to skilled nursing facility)
- no access to a working telephone (participants could list a friend or shelter phone)
- non-English speakding
- HIV positive (HIV+ patients were eligible for overlapping transitional care resources)
- disabling mental illness (as characterized by active psychosis or active suicidal ideation) or severe cognitive deficits
- plans to enter hospice.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
Usual care consists of 1) a routine nurse intake 2) medication reconciliation performed by treating physicians.
Given resource constraints (routine medication reconciliation did not include corroborating medication histories with outpatient pharmacies, routine use of pill cards or pill boxes, or review of Medicaid formularies) Uninsured patients were financially responsible for most medications at discharge.
3) Discharge patient education was performed by inpatient nurses and treating physicians at the time of discharge.
4) Patients without a usual source of primary care were often given a list of the fourteen area safety-net clinics, which have limited capacity for uncompensated care.
|
|
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Experimental: C-TraIn
Care Transitions Innovation (C-TraIn) was delivered in addition to usual care, and includes (1) transitional nurse coaching and education, including post-discharge phone calls and home visits for highest risk patients; (2) pharmacy care that includes patient education, medication reconciliation, guidance to inpatient providers to encourage low-cost medications, and provision of 30 days of medications after discharge for those without prescription drug coverage; (3) post-hospital primary care linkages; (4) and explicit efforts at system integration through monthly quality improvement meetings.
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Multi-component transitional care intervention including transitional nursing care, pharmacy care, and medical home linkages
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
30-day hospital readmissions
Time Frame: 30-days
|
30-days
|
|
Emergency Department use
Time Frame: 30-days post-discharge
|
30-days post-discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Care Transitions Measure (CTM-3)
Time Frame: Patient report at 30-days post hospital discharge
|
The 3 item care transitions measure (CTM-3) is a validated measure that assesses the quality of the care transition. It asks patients to rate agreement with the following:
It is being considered by NQF for public reporting. More Background can be found at: http://www.caretransitions.org/documents/CTM_FAQs.pdf |
Patient report at 30-days post hospital discharge
|
|
all cause mortality
Time Frame: 30-days post-discharge
|
30-days post-discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Activation Measure
Time Frame: 30-days post-discharge
|
Patient Activation Measure (PAM) is a 13-item validated measure of patient activation developed by Judith Hibbard and colleagues. Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the patient activation measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004;39 (4 pt 1):1005-1026. |
30-days post-discharge
|
Collaborators and Investigators
Publications and helpful links
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.
- Englander H, Michaels L, Chan B, Kansagara D. The care transitions innovation (C-TraIn) for socioeconomically disadvantaged adults: results of a cluster randomized controlled trial. J Gen Intern Med. 2014 Nov;29(11):1460-7. doi: 10.1007/s11606-014-2903-0. Epub 2014 Jun 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OHSU eIRB 6208
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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