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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02114515
Other study ID # PCORI-IH 1211-4365
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date October 2016

Study information

Verified date October 2018
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1029
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States University of Illinois Hospital Chicago Illinois

Sponsors (14)

Lead Sponsor Collaborator
University of Illinois at Chicago AcademyHealth, American Heart Association, Baystate Medical Center, COPD Foundation, Mended Hearts, National Jewish Health, Patient-Centered Outcomes Research Institute, Respiratory Health Association, Sickle Cell Disease Association of Illinois, Society of Hospital Medicine, The National Association of Social Workers Foundation, University of Illinois Sickle Cell Patient Council, University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Death Caregiver-reported and confirmed by EHR review 30 days post discharge
Secondary Death Caregiver-reported and confirmed by EHR review 60 days post discharge
Secondary Re-hospitalization or Death Confirmed by EHR review 30 days post discharge
Secondary Re-hospitalization or Death Confirmed by EHR review 60 days post discharge
Secondary ED Visit, Re-hospitalization, or Death Confirmed by EHR review 30 days post discharge
Secondary ED Visit, Re-hospitalization, or Death Confirmed by EHR review 60 days post discharge
Secondary Outpatient Healthcare Visit Self-reported 14 days post discharge
Secondary Outpatient Healthcare Visit EHR-reported 14 days post discharge
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