HospitalizationNCT01906645
Care Transitions Innovation (C-TraIn)
A study testing Care Transitions Innovation (C-TraIn) in people with Hospitalization, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality improvement project being implemented at OHSU to improve the transition from hospital to home for uninsured and Medicaid patients admitted to general medicine and cardiology wards at OHSU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- Care Transitions Innovation (C-TraIn)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2012
- 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
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Care Transitions Innovation (C-TraIn): Study of a Multi-component Transitional Care Intervention for Uninsured and Low-income Publicly Insured Adults
The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality improvement project being implemented at OHSU to improve the transition from hospital to home for uninsured and Medicaid patients admitted to general medicine and cardiology wards at OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge phone follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an effective way to assure timely, safe, and effective follow-up care for uninsured and underinsured hospitalized patients. Most uninsured patients have no source for primary care, and many have limited social support, complex medical problems, and are prescribed many medications. Patients are frequently discharged without any coordinated plan for follow up. Based on a needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a quality improvement program that will include three major components: 1) a care transitions RN advocate who will see patients in the hospital and after discharge, 2) a pharmacy consultation and 30 days of medications post-discharge, 3) linkages with primary care medical homes, including payment for primary care for uninsured patients who lack a usual source of care, and 4) monthly meetings that serve as a platform for continuous quality improvement. In order to measure the success of our program, investigators will track patient utilization, sociodemographic factors, and patient factors including satisfaction, activation, and self-reported health status. To be included patients must be uninsured, have Oregon Medicaid, or be low income (200% or less of federal poverty level) Medicare recipients, and live within Multnomah, Washington and Clackamas Counties in Oregon.
- Conditions
- Hospitalization
- Being tested
- Care Transitions Innovation (C-TraIn)
- Keywords
- Patient Readmission, Continuity of Patient Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Transitions Innovation (C-TraIn)Other
Multi-component transitional care intervention including transitional nursing care, pharmacy care, and medical home linkages
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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. |
| C-TraIn | Experimental | 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. Receives: Other: Care Transitions Innovation (C-TraIn) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day hospital readmissions
Measured: 30-days
Emergency Department use
Measured: 30-days post-discharge
Secondary outcomes (2)
Care Transitions Measure (CTM-3)
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:
- The hospital staff took my preferences and those of my family or caregiver into account in deciding what my health care needs would be when I left the hospital.
- When I left the hospital, I had a good understanding of the things I was responsible for in managing my health.
- When I left the hospital, I clearly understood the purpose for taking each of my medications.
It is being considered by NQF for public reporting. More Background can be found at: http://www.caretransitions.org/documents/CTM_FAQs.pdf
Measured: Patient report at 30-days post hospital discharge
all cause mortality
Measured: 30-days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startNov 2010
- Primary completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HospitalizationStudies 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
- Health services research
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Honora Englander, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906645
- Sponsor's protocol ID
- OHSU eIRB 6208
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- 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 22411913Englander 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.
PubMed 24913003
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Transitions Innovation (C-TraIn): Study of a Multi-component Transitional Care Intervention for Uninsured and Low-income Publicly Insured Adults
- ClinicalTrials.gov ID
- NCT01906645
- Acronym / sponsor ID
- OHSU eIRB 6208
- Conditions
- Hospitalization
- Keywords
- Patient Readmission, Continuity of Patient Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- First posted
- 24 Jul 2013 (estimated)
- 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.
The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality improvement project being implemented at OHSU to improve the transition from hospital to home for uninsured and Medicaid patients admitted to general medicine and cardiology wards at OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge phone follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an effective way to assure timely, safe, and effective follow-up care for uninsured and underinsured hospitalized patients. Most uninsured patients have no source for primary care, and many have limited social support, complex medical problems, and are prescribed many medications. Patients are frequently discharged without any coordinated plan for follow up. Based on a needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a quality improvement program that will include three major components: 1) a care transitions RN advocate who will see patients in the hospital and after discharge, 2) a pharmacy consultation and 30 days of medications post-discharge, 3) linkages with primary care medical homes, including payment for primary care for uninsured patients who lack a usual source of care, and 4) monthly meetings that serve as a platform for continuous quality improvement. In order to measure the success of our program, investigators will track patient utilization, sociodemographic factors, and patient factors including satisfaction, activation, and self-reported health status. To be included patients must be uninsured, have Oregon Medicaid, or be low income (200% or less of federal poverty level) Medicare recipients, and live within Multnomah, Washington and Clackamas Counties in Oregon.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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. |
| C-TraIn | Experimental | Other: Care Transitions Innovation (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Care Transitions Innovation (C-TraIn)Multi-component transitional care intervention including transitional nursing care, pharmacy care, and medical home linkages | Other | C-TraIn |
Primary outcome
30-day hospital readmissions
Time frame: 30-days
Emergency Department use
Time frame: 30-days post-discharge
2 secondary outcomes
Care Transitions Measure (CTM-3)
Time frame: Patient report at 30-days post hospital discharge
all cause mortality
Time frame: 30-days 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 24 Jul 2013.
- 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.
- Derived from this study: PubMed 24913003Englander 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Transitions Innovation (C-TraIn) in people with Hospitalization, run by Oregon Health and Science 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 3 inclusion and 6 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 24 Jul 2013. 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 readmissions (time frame: 30-days). The study lists 2 primary outcomes in all. 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 NCT01906645, which also lists 2 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 24 Jul 2013.