- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066492
Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults
Evaluation of a Novel Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization Among Low Income Adults
This randomized controlled trial examines the effects of a transitional care clinic for high-risk patients at an academic medical center who had no trusted medical home. The trial will provide the first reliable evaluation of the Northwestern Transitional Care Clinic / Follow Up Clinic's (NFC) impact on re-admissions, care coordination, and costs. This research will allow us to assess the value of the NFC and similar models of care for providing a more coordinated care approach that results in better treatment outcomes for urban poor populations.
It is hypothesized that NFC patients will have fewer 90-day re-hospitalizations and are more likely to have a usual source of primary care 6 months after discharge.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All patients eligible for Northwestern Transitional Follow Up care post-discharge from Northwestern Memorial Hospital
- Adults (18 years of age or older)
- Patients referred by an Northwestern Memorial Hospital care provider for discharge coordination by the Northwestern Transitional Follow Up Clinic
Exclusion Criteria:
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant Women
- Prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Federally Qualified Health Center
Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.
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Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.
|
|
EXPERIMENTAL: Northwestern Follow Up Care Coordination
Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.
|
Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
90-Day Re-hospitalization or Death
Time Frame: 90 days
|
90-day re-hospitalization (Emergency Department and/or inpatient admission) or death
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Usual Source of Primary Care
Time Frame: 6 months
|
Patient report of being seen in a usual source of primary medical care 6 months after discharge
|
6 months
|
|
30-Day Re-hospitalization or Death
Time Frame: 30 days
|
90-day re-hospitalization (Emergency Department and/or inpatient admission) or death
|
30 days
|
|
180-Day Re-hospitalization or Death
Time Frame: 180 days
|
180-day re-hospitalization (Emergency Department and/or inpatient admission) or death
|
180 days
|
|
365-Day Re-hospitalization or Death
Time Frame: 365 days
|
365-day re-hospitalization (Emergency Department and/or inpatient admission) or death
|
365 days
|
|
Health Advocate Effect
Time Frame: 12 months
|
This evaluation will determine if being offered support of a novel care team member known as a "health advocate" (a form of care navigator who will assist patients to overcome social determinants of readmission) is more likely to prevent hospital readmission than receiving the standard Northwestern Transitional Follow Up Care team intervention alone.
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12 months
|
|
Intervention Cost
Time Frame: 12 months
|
This is an evaluation of the incremental costs to implement and sustain standard Northwestern Transitional Follow Up team care, as well as the enhanced standard + health advocate personnel model
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ronald T Ackermann, MD, MPH, Northwestern University
Publications and helpful links
General Publications
- Liss DT, Ackermann RT, Cooper A, Finch EA, Hurt C, Lancki N, Rogers A, Sheth A, Teter C, Schaeffer C. Effects of a Transitional Care Practice for a Vulnerable Population: a Pragmatic, Randomized Comparative Effectiveness Trial. J Gen Intern Med. 2019 Sep;34(9):1758-1765. doi: 10.1007/s11606-019-05078-4. Epub 2019 May 29.
- Ackermann RT, Liss DT, French DD, Cooper AJ, Aikman C, Schaeffer C. Randomized Trial Evaluating Health System Expenditures with Transitional Care Services for Adults with No Usual Source of Care at Discharge. J Gen Intern Med. 2022 Nov;37(15):3832-3838. doi: 10.1007/s11606-022-07473-w. Epub 2022 Mar 9.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STU00200259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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