Chronic Obstructive Pulmonary DiseasePArTNERNCT02114515

PATient Navigator to rEduce Readmissions

A study testing Navigator intervention and Peer-led telephone support line in people with Chronic Obstructive Pulmonary Disease and Heart Failure, run by University of Illinois at Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease
What is being tested?: Navigator intervention and Peer-led telephone support line
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,029 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Oct 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Illinois Hospital
Chicago, Illinois, 60612

Other trials in United States

About this study

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.

Conditions: Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease, Myocardial Infarction, Pneumonia
Being tested: Hospital usual care, Navigator intervention, Peer-led telephone support line
Keywords: Patient Navigators, Readmissions, Peer Coaching
Medical subject headings: Pulmonary Disease, Chronic Obstructive, Heart Failure, Anemia, Sickle Cell, Myocardial Infarction, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hospital usual careBehavioural
Written discharge instructions provided to patients prior to hospital discharge.
Navigator interventionBehavioural
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 lineBehavioural
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 groups in NCT02114515
Study group	Role	What they receive
Usual Care	Other	Hospital usual care Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge. Receives: Behavioral: Hospital usual care
Usual Care + PArTNER	Experimental	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. Receives: Behavioral: Hospital usual care; Behavioral: Navigator intervention; Behavioral: Peer-led telephone support line

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 30 days post discharge

Secondary outcomes (18)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 60 days post discharge
Death
Caregiver-reported and confirmed by EHR review
Measured: 30 days post discharge
Death
Caregiver-reported and confirmed by EHR review
Measured: 60 days post discharge
Re-hospitalization or Death
Confirmed by EHR review
Measured: 30 days post discharge
Re-hospitalization or Death
Confirmed by EHR review
Measured: 60 days post discharge
ED Visit, Re-hospitalization, or Death
Confirmed by EHR review
Measured: 30 days post discharge
ED Visit, Re-hospitalization, or Death
Confirmed by EHR review
Measured: 60 days post discharge
Outpatient Healthcare Visit
Self-reported
Measured: 14 days post discharge
Outpatient Healthcare Visit
EHR-reported
Measured: 14 days post discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Oct 2016

First posted15 Apr 2014 (estimated)
Study startJul 2014
Primary completionOct 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,029 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02114515
Sponsor's protocol ID: PCORI-IH 1211-4365
Acronym: PArTNER
Status last verified: Oct 2018
First submitted: 1 Apr 2014
Last updated: 15 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 35260961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Enrolling by invitationObservational study
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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PATient Navigator to rEduce Readmissions
ClinicalTrials.gov ID: NCT02114515
Acronym / sponsor ID: PArTNER / PCORI-IH 1211-4365
Conditions: Chronic Obstructive Pulmonary Disease, Heart Failure, Sickle Cell Disease, Myocardial Infarction, Pneumonia
Keywords: Patient Navigators, Readmissions, Peer Coaching
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,029 participants (actual)
Lead sponsor: University of Illinois at ChicagoUniversity, hospital or other
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
Study start: Jul 2014
Primary completion: Oct 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 15 Apr 2014 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Usual Care	Other	Behavioral: Hospital usual careHospital usual care Hospital usual care: Written discharge instructions provided to patients prior to hospital discharge.
Usual Care + PArTNER	Experimental	Behavioral: Hospital usual care, Behavioral: Navigator intervention, Behavioral: Peer-led telephone support lineNavigator 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hospital usual careWritten discharge instructions provided to patients prior to hospital discharge.	Behavioural	Usual Care, Usual Care + PArTNER
Navigator interventionA Patient Navigator will provide social support, literacy appropriate education, and act as a conduit between the patient and the patient's medical team	Behavioural	Usual Care + PArTNER
Peer-led telephone support lineThe peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team.	Behavioural	Usual Care + PArTNER

Primary outcome

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.
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.

18 secondary outcomes

PROMIS Emotional Support (v2.0, SF4a)
Time frame: 30 days post discharge
PROMIS Instrumental Support (v2.0, SF4a)
Time frame: 30 days post discharge
PROMIS Global Health, Physical (v1.1, SF)
Time frame: 30 days post discharge
PROMIS Global Health, Mental (v1.1, SF)
Time frame: 30 days post discharge
PROMIS Emotional Distress-Anxiety (v1.0, SF4a)
Time frame: 60 days post discharge
PROMIS Informational Support (v2.0, SF4a)
Time frame: 60 days post discharge
PROMIS Emotional Support (v2.0, SF4a)
Time frame: 60 days post discharge
PROMIS Instrumental Support (v2.0, SF4a)
Time frame: 60 days post discharge
PROMIS Global Health, Physical (v1.1, SF)
Time frame: 60 days post discharge
PROMIS Global Health, Mental (v1.1, SF)
Time frame: 60 days post discharge
Death
Time frame: 30 days post discharge
Death
Time frame: 60 days post discharge
Re-hospitalization or Death
Time frame: 30 days post discharge
Re-hospitalization or Death
Time frame: 60 days post discharge
ED Visit, Re-hospitalization, or Death
Time frame: 30 days post discharge
ED Visit, Re-hospitalization, or Death
Time frame: 60 days post discharge
Outpatient Healthcare Visit
Time frame: 14 days post discharge
Outpatient Healthcare Visit
Time frame: 14 days post discharge

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	511	378
Usual Care + PArTNER	518	368

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

Time frame: 30 days post discharge. Mean (Standard Error). Unit: T-score

Measure	Usual Care n = 406	Usual Care + PArTNER n = 391
Value	-0.2 (0.5)	-1.7 (0.5)

Population analysed: Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.

Primary outcome: PROMIS Informational Support (v2.0, SF4a)

Time frame: 30 days post discharge. Mean (Standard Error). Unit: T-score

Measure	Usual Care n = 405	Usual Care + PArTNER n = 391
Value	2.3 (0.6)	2.5 (0.6)

Population analysed: Due to missing data, the number of participants analyzed may be less than the numbers provided in the Participant Flow module.

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from enrollment through 60 days after hospital discharge.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	12 of 511 (2.3%)	0 of 511 (0%)	12 of 511
Usual Care + PArTNER	12 of 518 (2.3%)	0 of 518 (0%)	12 of 518

Limitations and caveats (from the sponsor): No limitations or caveats to report.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35260961LaBedz 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.
Patient-Centered Outcomes Research Institute (PCORI): Funding Award detailsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry A Krishnan, MD, PhD principal investigator

University of Illinois at Chicago

Elizabeth Calhoun, PhD principal investigator

University of Arizona

Mark V. Williams, MD principal investigator

University of Kentucky

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS Emotional Distress-Anxiety (v1.0, SF4a) (time frame: 30 days post discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114515, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019; AzTrials last refreshed its copy on 26 Oct 2026.