Continuity of Patient CareCHAMPNCT03097640
Understanding Perspectives of Frequently-Admitted Hospital Patients
A study testing CHAMP in people with Continuity of Patient Care and High Utilizers of Hospital Care, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuity of Patient Care, High Utilizers of Hospital Care, Patient-Centered Care
- What is being tested?
- CHAMP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
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.
Read the detailed description
Frequent users of hospital services, otherwise known as hospital "high-utilizers," comprise a diverse patient population that pose unique challenges to the current US health care delivery model. The Complex High Admission Management Program (CHAMP), implemented at Northwestern Memorial Hospital in Chicago, IL, seeks to improve care for high-utilizer patients through provider continuity, intensive case management, and developing personalized care plans that span inpatient, outpatient, and emergency care environments.
Preliminary evaluation of CHAMP has shown a 38% decrease in 30-day unplanned hospital readmissions and an 18% decrease in ED encounters over a 6-month time period, when compared to an equal time period pre-CHAMP.
Patients are eligible for the program if they are readmitted to the hospital three times within a twelve-month period. Due to the time and resource limitations of the CHAMP team, not all patients meeting these criteria can be enrolled at once. Patients will thus be randomly selected to be enrolled in CHAMP or will receive usual care. This study plans to evaluate the difference in outcomes between patients enrolled in CHAMP and those receiving usual care by answering the following questions:
To what extent do high-utilizer patients enrolled in CHAMP differ in their level of trust in providers, self-assessed coping skills, daily symptom burden, perceived functionality, and attitudes about the healthcare system when compared to a control group of high utilizer patients receiving usual care? We will assess patient responses to a series of surveys assessing trust, feelings of discrimination, activation, satisfaction with care, and level of social functioning.
What are the healthcare utilization rates of high-utilizer patients enrolled in CHAMP compared to a control group of high-utilizer patients receiving usual care? We will compare rates of (a) hospital admission and (b) utilization (including length of stay) among high-utilizer patients enrolled in CHAMP as compared to high-utilizer patients not enrolled in the program.
- Being tested
- CHAMP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission Rate
180-day Inpatient Readmission Rate (as defined by Medicare) to Northwestern Memorial Hospital
Measured: 180-days from indexed hospital discharge
Secondary outcomes (22)
Readmission Rate
Inpatient Readmission Rate
Measured: 30 days from indexed hospital discharge
Readmission Rate
Inpatient Readmission Rate
Measured: 90 days from indexed hospital discharge
Inpatient Admissions
Inpatient Admission Rate to Northwestern Memorial Hospital
Measured: 30 days from indexed hospital discharge
Inpatient Admissions
Inpatient Admission Rate to Northwestern Memorial Hospital
Measured: 90 days from indexed hospital discharge
Inpatient Admissions
Inpatient Admission Rate to Northwestern Memorial Hospital
Measured: 180 days from indexed hospital discharge
Inpatient Admissions-total
Inpatient Admissions to all hospitals, as reported by patient
Measured: 30 days from indexed hospital discharge
Inpatient Admissions-total
Inpatient Admissions to all hospitals, as reported by patient
Measured: 90 days from indexed hospital discharge
Inpatient Admissions-total
Inpatient Admissions to all hospitals, as reported by patient
Measured: 180 days from indexed hospital discharge
ER Admissions
ER Visits to Northwestern Memoria
Measured: 180 days from indexed hospital discharge
ER Admissions
ER Visits to Northwestern Memoria
Measured: 30 days from indexed hospital discharge
ER Admissions
ER Visits to Northwestern Memoria
Measured: 90 days from indexed hospital discharge
ER Admissions-total
ER Visits to all hospitals, as reported by patient
Measured: 30 days from indexed hospital discharge
ER Admissions-total
ER Visits to all hospitals, as reported by patient
Measured: 90 days from indexed hospital discharge
ER Admissions-total
ER Visits to all hospitals, as reported by patient
Measured: 180 days from indexed hospital discharge
Hospital Length of Stay
Average Length of Stay at NMH during time period
Measured: 180 days from indexed hospital discharge
Hospital Length of Stay
Average Length of Stay at NMH during time period
Measured: 30 days from indexed hospital discharge
Hospital Length of Stay
Average Length of Stay at NMH during time period
Measured: 90 days from indexed hospital discharge
Clinic Visits
Number of total clinic visits
Measured: 180 days from indexed hospital discharge
Patient-Centered Outcomes
Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination
Measured: 30 days from indexed hospital discharge
Patient-Centered Outcomes
Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination
Measured: 90 days from indexed hospital discharge
Patient-Centered Outcomes
Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination
Measured: 180 days from indexed hospital discharge
Average costs
Estimated cost from billing code data for hospitalizations during time period
Measured: 180 days from indexed hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startNov 2016
- Primary completionJul 2020
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Continuity of Patient CareStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Lowell Henschen, Northwestern University
- Investigators
- Bruce L Henschen, MD/MPH, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097640
- Sponsor's protocol ID
- STU00203847
- Acronym
- CHAMP
- Status last verified
- Oct 2021
- First submitted
- 27 Mar 2017
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 34472021
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Perspectives of Frequently-Admitted Hospital Patients
- ClinicalTrials.gov ID
- NCT03097640
- Acronym / sponsor ID
- CHAMP / STU00203847
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frequent users of hospital services, otherwise known as hospital "high-utilizers," comprise a diverse patient population that pose unique challenges to the current US health care delivery model. The Complex High Admission Management Program (CHAMP), implemented at Northwestern Memorial Hospital in Chicago, IL, seeks to improve care for high-utilizer patients through provider continuity, intensive case management, and developing personalized care plans that span inpatient, outpatient, and emergency care environments.
Preliminary evaluation of CHAMP has shown a 38% decrease in 30-day unplanned hospital readmissions and an 18% decrease in ED encounters over a 6-month time period, when compared to an equal time period pre-CHAMP.
Patients are eligible for the program if they are readmitted to the hospital three times within a twelve-month period. Due to the time and resource limitations of the CHAMP team, not all patients meeting these criteria can be enrolled at once. Patients will thus be randomly selected to be enrolled in CHAMP or will receive usual care. This study plans to evaluate the difference in outcomes between patients enrolled in CHAMP and those receiving usual care by answering the following questions:
To what extent do high-utilizer patients enrolled in CHAMP differ in their level of trust in providers, self-assessed coping skills, daily symptom burden, perceived functionality, and attitudes about the healthcare system when compared to a control group of high utilizer patients receiving usual care? We will assess patient responses to a series of surveys assessing trust, feelings of discrimination, activation, satisfaction with care, and level of social functioning.
What are the healthcare utilization rates of high-utilizer patients enrolled in CHAMP compared to a control group of high-utilizer patients receiving usual care? We will compare rates of (a) hospital admission and (b) utilization (including length of stay) among high-utilizer patients enrolled in CHAMP as compared to high-utilizer patients not enrolled in the program.
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 |
|---|---|---|
| CHAMP | Experimental | Other: CHAMPParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| CHAMPCHAMP 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 |
Primary outcome
Readmission Rate
Time frame: 180-days from indexed hospital discharge
180-day Inpatient Readmission Rate (as defined by Medicare) to Northwestern Memorial Hospital
22 secondary outcomes
Readmission Rate
Time frame: 30 days from indexed hospital discharge
Readmission Rate
Time frame: 90 days from indexed hospital discharge
Inpatient Admissions
Time frame: 30 days from indexed hospital discharge
Inpatient Admissions
Time frame: 90 days from indexed hospital discharge
Inpatient Admissions
Time frame: 180 days from indexed hospital discharge
Inpatient Admissions-total
Time frame: 30 days from indexed hospital discharge
Inpatient Admissions-total
Time frame: 90 days from indexed hospital discharge
Inpatient Admissions-total
Time frame: 180 days from indexed hospital discharge
ER Admissions
Time frame: 180 days from indexed hospital discharge
ER Admissions
Time frame: 30 days from indexed hospital discharge
ER Admissions
Time frame: 90 days from indexed hospital discharge
ER Admissions-total
Time frame: 30 days from indexed hospital discharge
ER Admissions-total
Time frame: 90 days from indexed hospital discharge
ER Admissions-total
Time frame: 180 days from indexed hospital discharge
Hospital Length of Stay
Time frame: 180 days from indexed hospital discharge
Hospital Length of Stay
Time frame: 30 days from indexed hospital discharge
Hospital Length of Stay
Time frame: 90 days from indexed hospital discharge
Clinic Visits
Time frame: 180 days from indexed hospital discharge
Patient-Centered Outcomes
Time frame: 30 days from indexed hospital discharge
Patient-Centered Outcomes
Time frame: 90 days from indexed hospital discharge
Patient-Centered Outcomes
Time frame: 180 days from indexed hospital discharge
Average costs
Time frame: 180 days from indexed hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Derived from this study: PubMed 34472021Henschen 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.
- Individual participant dataSharing planned: No
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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.
Bruce L Henschen, MD/MPH principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAMP in people with Continuity of Patient Care and High Utilizers of Hospital Care, run by Northwestern University at 1 site in United States.
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 3 inclusion and 3 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 4 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Readmission Rate (time frame: 180-days from indexed hospital discharge). 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 NCT03097640, 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 4 Oct 2021.