Care Transitions Innovation (C-TraIn)

July 19, 2013 updated by: Honora Englander, Oregon Health and Science University

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

382

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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:

  1. 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.
  2. When I left the hospital, I had a good understanding of the things I was responsible for in managing my health.
  3. 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

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Estimate)

July 24, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

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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