PATient Navigator to rEduce Readmissions

Study Overview
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Brief Summary
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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.

Official Title
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PATient Navigator to rEduce Readmissions

Conditions
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Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease, Myocardial Infarction, Pneumonia

Intervention / Treatment
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* Behavioral: Hospital usual care
* Behavioral: Navigator intervention
* Behavioral: Peer-led telephone support line


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Care<br>Hospital usual care Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge. | Behavioral: Hospital usual care<br>* Written discharge instructions provided to patients prior to hospital discharge.<br>|
| Experimental: Usual Care + PArTNER<br>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<br>* Written discharge instructions provided to patients prior to hospital discharge.<br>Behavioral: Navigator intervention<br>* A Patient Navigator will provide social support, literacy appropriate education, and act as a conduit between the patient and the patient's medical team<br>Behavioral: Peer-led telephone support line<br>* The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post discharge | 
| 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. | 30 days post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days post discharge | 
| 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. | 30 days post discharge | 
| 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. | 30 days post discharge | 
| 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. | 30 days post discharge | 
| 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. | 60 days post discharge | 
| 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. | 60 days post discharge | 
| 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. | 60 days post discharge | 
| 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. | 60 days post discharge | 
| 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. | 60 days post discharge | 
| 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. | 60 days post discharge | 
| Death | Caregiver-reported and confirmed by EHR review | 30 days post discharge | 
| Death | Caregiver-reported and confirmed by EHR review | 60 days post discharge | 
| Re-hospitalization or Death | Confirmed by EHR review | 30 days post discharge | 
| Re-hospitalization or Death | Confirmed by EHR review | 60 days post discharge | 
| ED Visit, Re-hospitalization, or Death | Confirmed by EHR review | 30 days post discharge | 
| ED Visit, Re-hospitalization, or Death | Confirmed by EHR review | 60 days post discharge | 
| Outpatient Healthcare Visit | Self-reported | 14 days post discharge | 
| Outpatient Healthcare Visit | EHR-reported | 14 days post discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Navigators, Readmissions, Peer Coaching