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PATient Navigator to rEduce Readmissions (PArTNER)

Primary Purpose

Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hospital usual care
Navigator intervention
Peer-led telephone support line
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring Patient Navigators, Readmissions, Peer Coaching

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Usual Care

Usual Care + PArTNER

Arm Description

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

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.

Outcomes

Primary Outcome Measures

PROMIS Emotional Distress-Anxiety (v1.0, SF4a)
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)
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

PROMIS Emotional Support (v2.0, SF4a)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
Caregiver-reported and confirmed by EHR review
Death
Caregiver-reported and confirmed by EHR review
Re-hospitalization or Death
Confirmed by EHR review
Re-hospitalization or Death
Confirmed by EHR review
ED Visit, Re-hospitalization, or Death
Confirmed by EHR review
ED Visit, Re-hospitalization, or Death
Confirmed by EHR review
Outpatient Healthcare Visit
Self-reported
Outpatient Healthcare Visit
EHR-reported

Full Information

First Posted
April 1, 2014
Last Updated
October 1, 2018
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
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1. Study Identification

Unique Protocol Identification Number
NCT02114515
Brief Title
PATient Navigator to rEduce Readmissions
Acronym
PArTNER
Official Title
PATient Navigator to rEduce Readmissions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. 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 improve patient experience during hospital to home transition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease, Myocardial Infarction, Pneumonia
Keywords
Patient Navigators, Readmissions, Peer Coaching

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1029 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Other
Arm Description
Hospital usual care Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.
Arm Title
Usual Care + PArTNER
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hospital usual care
Intervention Description
Written discharge instructions provided to patients prior to hospital discharge.
Intervention Type
Behavioral
Intervention Name(s)
Navigator intervention
Intervention Description
A Patient Navigator will provide social support, literacy appropriate education, and act as a conduit between the patient and the patient's medical team
Intervention Type
Behavioral
Intervention Name(s)
Peer-led telephone support line
Intervention Description
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 Measure Information:
Title
PROMIS Emotional Distress-Anxiety (v1.0, SF4a)
Description
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.
Time Frame
30 days post discharge
Title
PROMIS Informational Support (v2.0, SF4a)
Description
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.
Time Frame
30 days post discharge
Secondary Outcome Measure Information:
Title
PROMIS Emotional Support (v2.0, SF4a)
Description
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.
Time Frame
30 days post discharge
Title
PROMIS Instrumental Support (v2.0, SF4a)
Description
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.
Time Frame
30 days post discharge
Title
PROMIS Global Health, Physical (v1.1, SF)
Description
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.
Time Frame
30 days post discharge
Title
PROMIS Global Health, Mental (v1.1, SF)
Description
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.
Time Frame
30 days post discharge
Title
PROMIS Emotional Distress-Anxiety (v1.0, SF4a)
Description
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.
Time Frame
60 days post discharge
Title
PROMIS Informational Support (v2.0, SF4a)
Description
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.
Time Frame
60 days post discharge
Title
PROMIS Emotional Support (v2.0, SF4a)
Description
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.
Time Frame
60 days post discharge
Title
PROMIS Instrumental Support (v2.0, SF4a)
Description
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.
Time Frame
60 days post discharge
Title
PROMIS Global Health, Physical (v1.1, SF)
Description
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.
Time Frame
60 days post discharge
Title
PROMIS Global Health, Mental (v1.1, SF)
Description
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.
Time Frame
60 days post discharge
Title
Death
Description
Caregiver-reported and confirmed by EHR review
Time Frame
30 days post discharge
Title
Death
Description
Caregiver-reported and confirmed by EHR review
Time Frame
60 days post discharge
Title
Re-hospitalization or Death
Description
Confirmed by EHR review
Time Frame
30 days post discharge
Title
Re-hospitalization or Death
Description
Confirmed by EHR review
Time Frame
60 days post discharge
Title
ED Visit, Re-hospitalization, or Death
Description
Confirmed by EHR review
Time Frame
30 days post discharge
Title
ED Visit, Re-hospitalization, or Death
Description
Confirmed by EHR review
Time Frame
60 days post discharge
Title
Outpatient Healthcare Visit
Description
Self-reported
Time Frame
14 days post discharge
Title
Outpatient Healthcare Visit
Description
EHR-reported
Time Frame
14 days post discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older on date of hospital admission Hospitalized at the University of Illinois Hospital, Chicago Admission diagnosis, per treating physician, of pneumonia, COPD, sickle cell disease, heart failure, or myocardial infarction Receive medical care on an inpatient medical service Exclusion Criteria: Unable to understand and speak English Unable/decline to give informed consent Previous participant in PArTNER Planned transfer to another acute care facility Planned discharge to facility other than home (e.g. long term care facility) Currently on hospice or plans to discharge home to hospice Current plans to leave against medical advice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerry A Krishnan, MD, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Calhoun, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark V. Williams, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35260961
Citation
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.
Results Reference
derived
Links:
URL
http://www.pcori.org/research-results/2013/patient-navigator-reduce-readmissions-partner
Description
Patient-Centered Outcomes Research Institute (PCORI): Funding Award details

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PATient Navigator to rEduce Readmissions

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