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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097640
Other study ID # STU00203847
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2016
Est. completion date October 2021

Study information

Verified date October 2021
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 151
Est. completion date October 2021
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - 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). Exclusion Criteria: - 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.

Study Design


Intervention

Other:
CHAMP
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.

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission Rate 180-day Inpatient Readmission Rate (as defined by Medicare) to Northwestern Memorial Hospital 180-days from indexed hospital discharge
Secondary Readmission Rate Inpatient Readmission Rate 30 days from indexed hospital discharge
Secondary Readmission Rate Inpatient Readmission Rate 90 days from indexed hospital discharge
Secondary Inpatient Admissions Inpatient Admission Rate to Northwestern Memorial Hospital 30 days from indexed hospital discharge
Secondary Inpatient Admissions Inpatient Admission Rate to Northwestern Memorial Hospital 90 days from indexed hospital discharge
Secondary Inpatient Admissions Inpatient Admission Rate to Northwestern Memorial Hospital 180 days from indexed hospital discharge
Secondary Inpatient Admissions-total Inpatient Admissions to all hospitals, as reported by patient 30 days from indexed hospital discharge
Secondary Inpatient Admissions-total Inpatient Admissions to all hospitals, as reported by patient 90 days from indexed hospital discharge
Secondary Inpatient Admissions-total Inpatient Admissions to all hospitals, as reported by patient 180 days from indexed hospital discharge
Secondary ER Admissions ER Visits to Northwestern Memoria 180 days from indexed hospital discharge
Secondary ER Admissions ER Visits to Northwestern Memoria 30 days from indexed hospital discharge
Secondary ER Admissions ER Visits to Northwestern Memoria 90 days from indexed hospital discharge
Secondary ER Admissions-total ER Visits to all hospitals, as reported by patient 30 days from indexed hospital discharge
Secondary ER Admissions-total ER Visits to all hospitals, as reported by patient 90 days from indexed hospital discharge
Secondary ER Admissions-total ER Visits to all hospitals, as reported by patient 180 days from indexed hospital discharge
Secondary Hospital Length of Stay Average Length of Stay at NMH during time period 180 days from indexed hospital discharge
Secondary Hospital Length of Stay Average Length of Stay at NMH during time period 30 days from indexed hospital discharge
Secondary Hospital Length of Stay Average Length of Stay at NMH during time period 90 days from indexed hospital discharge
Secondary Clinic Visits Number of total clinic visits 180 days from indexed hospital discharge
Secondary Patient-Centered Outcomes Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination 30 days from indexed hospital discharge
Secondary Patient-Centered Outcomes Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination 90 days from indexed hospital discharge
Secondary Patient-Centered Outcomes Responses to PROMIS Profile Scales, Trust in Physicians, Patient Activation, and Feelings of Discrimination 180 days from indexed hospital discharge
Secondary Average costs Estimated cost from billing code data for hospitalizations during time period 180 days from indexed hospital discharge
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