NCT03097640

Brief Summary

This study evaluates the clinical outcomes of a novel program designed to target patients who are high-utilizers of hospital services. Patients who are frequently admitted to medical services - "high-utilizers" - present a unique set of challenges to providers and the health care system that require a different way of approaching chronic illness. The Complex High Admission Management Program (CHAMP) is an innovative model of care consisting of a small team of providers who establish continuity relationships with high-utilizer patients. CHAMP strives to provide effective, high value care via a longitudinal relationship-based care model through provider continuity, intensive case management, and personalized care plans. To better understand the potential outcomes of CHAMP, this study is a longitudinal, prospective, randomized, controlled trial of medical high-utilizers enrolled in CHAMP compared to a group of high-utilizer patients receiving usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 4, 2021

Status Verified

October 1, 2021

Enrollment Period

3.7 years

First QC Date

March 27, 2017

Last Update Submit

October 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Readmission Rate

    180-day Inpatient Readmission Rate (as defined by Medicare) to Northwestern Memorial Hospital

    180-days from indexed hospital discharge

Secondary Outcomes (22)

  • Readmission Rate

    30 days from indexed hospital discharge

  • Readmission Rate

    90 days from indexed hospital discharge

  • Inpatient Admissions

    30 days from indexed hospital discharge

  • Inpatient Admissions

    90 days from indexed hospital discharge

  • Inpatient Admissions

    180 days from indexed hospital discharge

  • +17 more secondary outcomes

Study Arms (2)

CHAMP

EXPERIMENTAL

Participants enrolled in CHAMP are followed by a team of a social worker and physician across the care continuum. CHAMP team members visit patients in the ED and on inpatient floors. Along with the patient's input, the team develops an Individualized Care Plan outlining the patient's medical and social history and providing recommendations to other providers on specific aspects of their care. Care plans are reviewed with patients on an individual basis and reviewed periodically by the CHAMP providers. CHAMP-enrolled participants are scheduled for physician and social worker follow-up appointments at the CHAMP clinic; this time is used to provide intensive case management, medical care, and psychosocial support.

Other: CHAMP

Standard Care

NO INTERVENTION

Individuals in the standard care arm will receive care as they do normally when hospitalized, including medical and inpatient social work services, as well as outpatient care from their providers.

Interventions

CHAMPOTHER

CHAMP team members visit patients in the ED and on inpatient floors. Along with the patient's input, the team develops an Individualized Care Plan outlining the patient's medical and social history and providing recommendations to other providers on specific aspects of their care. Care plans are reviewed with patients on an individual basis and reviewed periodically by the CHAMP providers. CHAMP-enrolled participants are scheduled for physician and social worker follow-up appointments at the CHAMP clinic; this time is used to provide intensive case management, medical care, and psychosocial support.

CHAMP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18 yrs of age or older) who are admitted to Northwestern Memorial Hospital (NMH) and identified by EDW search as having two unplanned 30-day inpatient readmissions to NMH within the prior 12 months with one of two additional criteria:at least 1 readmission in the last 6 months, or a referral from one of that patient's medical providers.
  • Admission to NMH during the study period (October 1, 2016 to September 30, 2018) and meeting criteria described above for CHAMP
  • Ability to consent for this study (including ability to read materials printed in English, understanding and communicating in English, and able to understand the risks and benefits of participating in the study).

You may not qualify if:

  • Patients who are admitted to the Intensive Care Unit, patients admitted to Oncology services (as we have found that this latter group has a multidisciplinary care team already in place), or patients actively followed by the Heart Failure Bridge and Transition (BAT) Team, a different quality improvement intervention designed to reduce readmissions among patients admitted for acute decompensated heart failure.
  • Participants will be excluded if they are disoriented to person, place, or time, or are unable to consent for any other reason.
  • Minors, pregnant women, and prisoners will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Henschen BL, Theodorou ME, Chapman M, Barra M, Toms A, Cameron KA, Zhou S, Yeh C, Lee J, O'Leary KJ. An Intensive Intervention to Reduce Readmissions for Frequently Hospitalized Patients: the CHAMP Randomized Controlled Trial. J Gen Intern Med. 2022 Jun;37(8):1877-1884. doi: 10.1007/s11606-021-07048-1. Epub 2021 Sep 1.

Study Officials

  • Bruce L Henschen, MD/MPH

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2017

First Posted

March 31, 2017

Study Start

November 1, 2016

Primary Completion

July 1, 2020

Study Completion

October 1, 2021

Last Updated

October 4, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations