PATient Navigator to rEduce Readmissions (PArTNER)

October 1, 2018 updated by: Jerry Krishnan, University of Illinois at Chicago
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1029

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Usual Care

Hospital usual care

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days post discharge
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.
30 days post discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
30 days post discharge
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.
30 days post discharge
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.
30 days post discharge
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.
30 days post discharge
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.
60 days post discharge
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.
60 days post discharge
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.
60 days post discharge
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.
60 days post discharge
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.
60 days post discharge
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.
60 days post discharge
Death
Time Frame: 30 days post discharge
Caregiver-reported and confirmed by EHR review
30 days post discharge
Death
Time Frame: 60 days post discharge
Caregiver-reported and confirmed by EHR review
60 days post discharge
Re-hospitalization or Death
Time Frame: 30 days post discharge
Confirmed by EHR review
30 days post discharge
Re-hospitalization or Death
Time Frame: 60 days post discharge
Confirmed by EHR review
60 days post discharge
ED Visit, Re-hospitalization, or Death
Time Frame: 30 days post discharge
Confirmed by EHR review
30 days post discharge
ED Visit, Re-hospitalization, or Death
Time Frame: 60 days post discharge
Confirmed by EHR review
60 days post discharge
Outpatient Healthcare Visit
Time Frame: 14 days post discharge
Self-reported
14 days post discharge
Outpatient Healthcare Visit
Time Frame: 14 days post discharge
EHR-reported
14 days post discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Chicago

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute
American Heart Association
University of Kentucky
Baystate Medical Center
National Jewish Health
COPD Foundation
Society of Hospital Medicine
Mended Hearts
Sickle Cell Disease Association of Illinois
AcademyHealth
The National Association of Social Workers Foundation
Respiratory Health Association
University of Illinois Sickle Cell Patient Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCORI-IH 1211-4365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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