Evaluation of a Hospital Discharge Clinic to Improve Care Coordination and Reduce Rehospitalization in Low Income Adults

June 21, 2019 updated by: Ronald Ackermann, Northwestern University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The Northwestern Transitional Care Follow-up Clinic (NFC) was established in 2012 to improve the coordination of care for these patients following inpatient or Emergency Department discharge from Northwestern Memorial Hospital. Since 2012, the NFC has constructed an integrated team care approach, logging about 2000 post-discharge encounters with Medicaid or patients without insurance. The NFC model has evolved over the past 2 years in response to a need to address mental as well as physical health needs and to interface with community resources to address social determinants of health that might otherwise lead to frequent re-admission. By working with clinical partners and public payers like Medicaid and County Care, the NFC has also worked to transition patients to accessible primary care medical homes that will provide behavioral, physical, and preventive care. The current study will provide the first reliable evaluation of the clinic's 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
654

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Northwestern Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ronald T Ackermann, MD, MPH, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00200259

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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