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PATient Navigator to rEduce Readmissions (PArTNER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02114515
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
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
University of Illinois Sickle Cell Patient Council
National Jewish Health
Baystate Medical Center
Information provided by (Responsible Party):
Jerry Krishnan, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE April 1, 2014
First Posted Date  ICMJE April 15, 2014
Results First Submitted Date  ICMJE October 20, 2017
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 15, 2019
Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • PROMIS Emotional Distress-Anxiety (v1.0, SF4a) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates improvement. A change equal to 0 indicates no change. A change >0 indicates worsening.
  • PROMIS Informational Support (v2.0, SF4a) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Social Support [ Time Frame: 60 days post discharge ]
    Assessed using NIH PROMIS Instrument
  • Anxiety [ Time Frame: 60 days post discharge ]
    Assessed using NIH PROMIS Instrument
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
  • PROMIS Emotional Support (v2.0, SF4a) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Instrumental Support (v2.0, SF4a) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Global Health, Physical (v1.1, SF) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Global Health, Mental (v1.1, SF) [ Time Frame: 30 days post discharge ]
    Change in T-score from baseline to 30 days post discharge (30 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Emotional Distress-Anxiety (v1.0, SF4a) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates improvement. A change equal to 0 indicates no change. A change >0 indicates worsening.
  • PROMIS Informational Support (v2.0, SF4a) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Emotional Support (v2.0, SF4a) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Instrumental Support (v2.0, SF4a) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Global Health, Physical (v1.1, SF) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • PROMIS Global Health, Mental (v1.1, SF) [ Time Frame: 60 days post discharge ]
    Change in T-score from baseline to 60 days post discharge (60 days minus baseline). A change in t-score <0 indicates worsening. A change equal to 0 indicates no change. A change >0 indicates improvement.
  • Death [ Time Frame: 30 days post discharge ]
    Caregiver-reported and confirmed by EHR review
  • Death [ Time Frame: 60 days post discharge ]
    Caregiver-reported and confirmed by EHR review
  • Re-hospitalization or Death [ Time Frame: 30 days post discharge ]
    Confirmed by EHR review
  • Re-hospitalization or Death [ Time Frame: 60 days post discharge ]
    Confirmed by EHR review
  • ED Visit, Re-hospitalization, or Death [ Time Frame: 30 days post discharge ]
    Confirmed by EHR review
  • ED Visit, Re-hospitalization, or Death [ Time Frame: 60 days post discharge ]
    Confirmed by EHR review
  • Outpatient Healthcare Visit [ Time Frame: 14 days post discharge ]
    Self-reported
  • Outpatient Healthcare Visit [ Time Frame: 14 days post discharge ]
    EHR-reported
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PATient Navigator to rEduce Readmissions
Official Title  ICMJE PATient Navigator to rEduce Readmissions
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 improve patient experience during hospital to home transition.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease
  • Heart Failure
  • Sickle Cell Disease
  • Myocardial Infarction
  • Pneumonia
Intervention  ICMJE
  • Behavioral: Hospital usual care
    Written discharge instructions provided to patients prior to hospital discharge.
  • Behavioral: Navigator intervention
    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.
Study Arms  ICMJE
  • Usual Care

    Hospital usual care

    Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.

    Intervention: Behavioral: Hospital usual care
  • Experimental: Usual Care + PArTNER

    Navigator intervention: (Community health worker, peer-led telephone support line, usual care)

    Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.

    Community health worker: The community health worker provides social support, literacy appropriate education, and acts as a conduit between the patient and the patient's medical team

    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.

    Interventions:
    • Behavioral: Hospital usual care
    • Behavioral: Navigator intervention
    • Behavioral: Peer-led telephone support line
Publications * LaBedz SL, Prieto-Centurion V, Mutso A, Basu S, Bracken NE, Calhoun EA, DiDomenico RJ, Joo M, Pickard AS, Pittendrigh B, Williams MV, Illendula S, Krishnan JA. Pragmatic Clinical Trial to Improve Patient Experience Among Adults During Transitions from Hospital to Home: the PArTNER study. J Gen Intern Med. 2022 Mar 8. doi: 10.1007/s11606-022-07461-0. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2018)
1029
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
1130
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18 years or older on date of hospital admission
  2. Hospitalized at the University of Illinois Hospital, Chicago
  3. Admission diagnosis, per treating physician, of pneumonia, COPD, sickle cell disease, heart failure, or myocardial infarction
  4. Receive medical care on an inpatient medical service

Exclusion Criteria:

  1. Unable to understand and speak English
  2. Unable/decline to give informed consent
  3. Previous participant in PArTNER
  4. Planned transfer to another acute care facility
  5. Planned discharge to facility other than home (e.g. long term care facility)
  6. Currently on hospice or plans to discharge home to hospice
  7. Current plans to leave against medical advice
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02114515
Other Study ID Numbers  ICMJE PCORI-IH 1211-4365
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jerry Krishnan, University of Illinois at Chicago
Original Responsible Party Jerry Krishnan, University of Illinois at Chicago, Professor of Medicine and Public Health; Associate Vice President for Population Health Sciences
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Patient-Centered Outcomes Research Institute
  • 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
  • University of Illinois Sickle Cell Patient Council
  • National Jewish Health
  • Baystate Medical Center
Investigators  ICMJE
Principal Investigator: Jerry A Krishnan, MD, PhD University of Illinois at Chicago
Principal Investigator: Elizabeth Calhoun, PhD University of Arizona
Principal Investigator: Mark V. Williams, MD University of Kentucky
PRS Account University of Illinois at Chicago
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP