NCT01906645

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
382

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

July 17, 2013

Last Update Submit

July 19, 2013

Conditions

Keywords

Patient ReadmissionContinuity of Patient Care

Outcome Measures

Primary Outcomes (2)

  • 30-day hospital readmissions

    30-days

  • Emergency Department use

    30-days post-discharge

Secondary Outcomes (2)

  • Care Transitions Measure (CTM-3)

    Patient report at 30-days post hospital discharge

  • all cause mortality

    30-days post-discharge

Other Outcomes (1)

  • Patient Activation Measure

    30-days post-discharge

Study Arms (2)

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.

Other: Care Transitions Innovation (C-TraIn)

Interventions

Multi-component transitional care intervention including transitional nursing care, pharmacy care, and medical home linkages

C-TraIn

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 22411913BACKGROUND
  • 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Medical Director of Care Transitions Innovation (C-TraIn)

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 24, 2013

Study Start

November 1, 2010

Primary Completion

March 1, 2012

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations