PATient Navigator to rEduce Readmissions (PArTNER)

• 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: University of Illinois at Chicago
• 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: April 1, 2014
• First Posted Date: April 15, 2014
• Results First Submitted Date: October 20, 2017
• Results First Posted Date: February 15, 2019
• Last Update Posted Date: February 15, 2019
• Study Start Date: July 2014
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PATient Navigator to rEduce Readmissions
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Health Services Research

Condition

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Sickle Cell Disease
• Myocardial Infarction
• Pneumonia

Intervention

• 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

• 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 Dec;37(16):4103-4111. doi: 10.1007/s11606-022-07461-0. Epub 2022 Mar 8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 1, 2018): 1029
• Original Estimated Enrollment (submitted: April 10, 2014): 1130
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02114515
• Other Study ID Numbers: PCORI-IH 1211-4365
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: 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: University of Illinois at Chicago
• Original Study Sponsor: Same as current

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

Investigators

• 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