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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03066492
Other study ID # STU00200259
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2015
Est. completion date May 1, 2017

Study information

Verified date June 2019
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 654
Est. completion date May 1, 2017
Est. primary completion date May 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Northwestern University Northwestern Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 May — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 90-Day Re-hospitalization or Death 90-day re-hospitalization (Emergency Department and/or inpatient admission) or death 90 days
Secondary Usual Source of Primary Care Patient report of being seen in a usual source of primary medical care 6 months after discharge 6 months
Secondary 30-Day Re-hospitalization or Death 90-day re-hospitalization (Emergency Department and/or inpatient admission) or death 30 days
Secondary 180-Day Re-hospitalization or Death 180-day re-hospitalization (Emergency Department and/or inpatient admission) or death 180 days
Secondary 365-Day Re-hospitalization or Death 365-day re-hospitalization (Emergency Department and/or inpatient admission) or death 365 days
Secondary Health Advocate Effect 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
Secondary Intervention Cost 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
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