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History of Changes for Study: NCT02114515
PATient Navigator to rEduce Readmissions (PArTNER)
Latest version (submitted October 1, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 10, 2014 None (earliest Version on record)
2 November 18, 2014 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 3, 2014 Study Status, Eligibility and Conditions
4 June 2, 2015 Study Status, References, Contacts/Locations, Eligibility, Outcome Measures and Study Description
5 December 4, 2015 Sponsor/Collaborators, Study Status and Contacts/Locations
6 October 28, 2016 Recruitment Status, Study Status, Sponsor/Collaborators, Contacts/Locations and Study Design
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Results Submission Events
7 October 1, 2018 Recruitment Status, Study Status, Outcome Measures, Arms and Interventions, Study Design, Sponsor/Collaborators and Results
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Study NCT02114515
Submitted Date:  April 10, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: PCORI-IH 1211-4365
Brief Title: PATient Navigator to rEduce Readmissions (PArTNER)
Official Title: PATient Navigator to rEduce Readmissions
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2014
Overall Status: Not yet recruiting
Study Start: October 2014
Primary Completion: April 2016 [Anticipated]
Study Completion: April 2016 [Anticipated]
First Submitted: April 1, 2014
First Submitted that
Met QC Criteria:
April 10, 2014
First Posted: April 15, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 10, 2014
Last Update Posted: April 15, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Illinois at Chicago
Responsible Party: Principal Investigator
Investigator: Jerry Krishnan
Official Title: Professor of Medicine and Public Health; Associate Vice President for Population Health Sciences
Affiliation: University of Illinois at Chicago
Collaborators: Patient-Centered Outcomes Research Institute
University of Illinois at Urbana-Champaign
Society of Hospital Medicine
COPD Foundation
University of Kentucky
Mended Hearts
American Heart Association
Sickle Cell Disease Association of Illinois
AcademyHealth
The National Association of Social Workers Foundation
Respiratory Health Association of Metropolitan Chicago
University of Illinois Sickle Cell Patient Council
National Jewish Health
Olmsted Medical Center
Baystate Medical Center
US Department of Veterans Affairs
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Staying out of the hospital is valued by patients and their caregivers. Their interests converge with those of hospitals now that high 30-day readmission rates for some conditions place hospitals at risk for financial penalties from the Centers for Medicare and Medicaid Services. This study focuses on developing and testing a program that combines a community health worker (lay patient advocate, acting as a "Patient Navigator") and a peer-led telephone support line to increase social support, improve self-efficacy and decrease post-discharge acute care use.
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Obstructive Pulmonary Disease
Heart Failure
Sickle Cell Disease
Myocardial Infarction
Pneumonia
Vascular Procedures
Keywords: Patient Navigators
Readmissions
Peer Coaching
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Health Services Research
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 1130 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Usual Care
Hospital usual care
Behavioral: Hospital usual care
Written discharge instructions provided to patients prior to hospital discharge.
Experimental: Usual Care + PArTNER
Patient Navigator, peer-led telephone support line, usual care
Behavioral: Hospital usual care
Written discharge instructions provided to patients prior to hospital discharge.
Behavioral: Patient Navigator
A Patient Navigator will provide social support, literacy appropriate education, and act as a conduit between the patient and the patient's medical team
Behavioral: Peer-led telephone support line
The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Social Support
[ Time Frame: 60 days post discharge ]

Assessed using NIH PROMIS Instrument
2. Anxiety
[ Time Frame: 60 days post discharge ]

Assessed using NIH PROMIS Instrument
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age 18 years or older
  2. Admission to inpatient medical service
  3. Admission diagnosis of pneumonia, COPD exacerbation, sickle cell disease, heart failure, myocardial infarction, or vascular procedure
  4. Working telephone number

Exclusion Criteria:

  1. Unable to speak English or Spanish
  2. Unable to give informed consent
  3. Planned discharge home to hospice or to long term care facility
Open or close this module Contacts/Locations
Central Contact Person: Jerry A Krishnan, MD, PhD
Telephone: 1-855-494-3393
Email: partner@uic.edu
Central Contact Backup: Stephanie L Lewis
Telephone: 1-855-494-3393
Email: partner@uic.edu
Study Officials: Jerry A Krishnan, MD, PhD
Principal Investigator
University of Illinois at Chicago
Elizabeth Calhoun, PhD
Principal Investigator
University of Illinois at Chicago
Mark V. Williams, MD
Principal Investigator
University of Kentucky
Locations: United States, Illinois
University of Illinois Hospital
Chicago, Illinois, United States, 60612
Contact:Principal Investigator: Jerry A Krishnan, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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