PATient Navigator to rEduce Readmissions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02114515

Acronym

PArTNER

Enrollment

1029

Registered

2014-04-15

Start date

2014-07-31

Completion date

2016-10-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Patient Navigators, Readmissions, Peer Coaching

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.

Interventions

BEHAVIORALHospital usual care

Written discharge instructions provided to patients prior to hospital discharge.

BEHAVIORALNavigator 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

BEHAVIORALPeer-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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
PROMIS Emotional Distress-Anxiety (v1.0, SF4a)	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)	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

Measure	Time frame	Description
PROMIS Global Health, Physical (v1.1, SF)	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)	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)	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)	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)	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.
Re-hospitalization or Death	30 days post discharge	Confirmed by EHR review
ED Visit, Re-hospitalization, or Death	30 days post discharge	Confirmed by EHR review
Outpatient Healthcare Visit	14 days post discharge	Self-reported
Death	30 days post discharge	Caregiver-reported and confirmed by EHR review
PROMIS Instrumental Support (v2.0, SF4a)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Usual Care Hospital usual care Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.	511
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.	518
Total	1,029

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	12	12
Overall Study	Lost to Follow-up	52	55
Overall Study	Other	65	61
Overall Study	Withdrawal by Subject	4	22

Baseline characteristics

Characteristic	Usual Care	Usual Care + PArTNER	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	99 Participants	95 Participants	194 Participants
Age, Categorical Between 18 and 65 years	412 Participants	423 Participants	835 Participants
Age, Continuous	49.9 years STANDARD_DEVIATION 17	49.8 years STANDARD_DEVIATION 16.5	49.9 years STANDARD_DEVIATION 16.8
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants	49 Participants	89 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	471 Participants	468 Participants	939 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Asian	4 Participants	6 Participants	10 Participants
Race (NIH/OMB) Black or African American	424 Participants	423 Participants	847 Participants
Race (NIH/OMB) More than one race	7 Participants	4 Participants	11 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants	10 Participants	23 Participants
Race (NIH/OMB) White	62 Participants	72 Participants	134 Participants
Region of Enrollment United States	511 participants	518 participants	1029 participants
Sex: Female, Male Female	290 Participants	277 Participants	567 Participants
Sex: Female, Male Male	221 Participants	241 Participants	462 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	12 / 511	12 / 518
other Total, other adverse events	0 / 511	0 / 518
serious Total, serious adverse events	12 / 511	12 / 518

Outcome results

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.

Time frame: 30 days post discharge