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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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Heart Failure Sickle Cell Disease Myocardial Infarction Pneumonia Behavioral: Hospital usual care Behavioral: Navigator intervention Behavioral: Peer-led telephone support line Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1029 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: PATient Navigator to rEduce Readmissions
Study Start Date : July 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Usual Care

Hospital usual care

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

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

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.

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.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. 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.


  7. 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.


  8. 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.


  9. 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.


  10. 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.


  11. Death [ Time Frame: 30 days post discharge ]
    Caregiver-reported and confirmed by EHR review

  12. Death [ Time Frame: 60 days post discharge ]
    Caregiver-reported and confirmed by EHR review

  13. Re-hospitalization or Death [ Time Frame: 30 days post discharge ]
    Confirmed by EHR review

  14. Re-hospitalization or Death [ Time Frame: 60 days post discharge ]
    Confirmed by EHR review

  15. ED Visit, Re-hospitalization, or Death [ Time Frame: 30 days post discharge ]
    Confirmed by EHR review

  16. ED Visit, Re-hospitalization, or Death [ Time Frame: 60 days post discharge ]
    Confirmed by EHR review

  17. Outpatient Healthcare Visit [ Time Frame: 14 days post discharge ]
    Self-reported

  18. Outpatient Healthcare Visit [ Time Frame: 14 days post discharge ]
    EHR-reported



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114515


Locations
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United States, Illinois
University of Illinois Hospital
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
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
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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

Additional Information:
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Responsible Party: Jerry Krishnan, Professor of Medicine and Public Health; Associate Vice Chancellor for Population Health Sciences, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02114515    
Other Study ID Numbers: PCORI-IH 1211-4365
First Posted: April 15, 2014    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: October 2018
Keywords provided by Jerry Krishnan, University of Illinois at Chicago:
Patient Navigators
Readmissions
Peer Coaching
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Myocardial Infarction
Anemia, Sickle Cell
Infarction
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Respiratory Tract Infections
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn