NCT03066492

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
654

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

February 22, 2017

Last Update Submit

June 21, 2019

Conditions

Patient Readmission

Keywords

Tertiary Care CenterPatient ReadmissionHealth Services ResearchHospital Readmissions

Outcome Measures

Primary Outcomes (1)

  • 90-Day Re-hospitalization or Death

    90-day re-hospitalization (Emergency Department and/or inpatient admission) or death

    90 days

Secondary Outcomes (6)

  • Usual Source of Primary Care

    6 months

  • 30-Day Re-hospitalization or Death

    30 days

  • 180-Day Re-hospitalization or Death

    180 days

  • 365-Day Re-hospitalization or Death

    365 days

  • Health Advocate Effect

    12 months

  • +1 more secondary outcomes

Study Arms (2)

Federally Qualified Health Center

ACTIVE COMPARATOR

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

Northwestern Follow Up Care Coordination

EXPERIMENTAL

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

Interventions

Northwestern Follow Up Care CoordinationOTHER

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.

Northwestern Follow Up Care Coordination
Federally Qualified Health CenterOTHER

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.

Federally Qualified Health Center

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant Women
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • 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.

    PMID: 31144279RESULT

  • 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.

    PMID: 35266127DERIVED

Study Officials

  • Ronald T Ackermann, MD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Dean for Public Health, Director, Institute for Public Health and Medicine, Professor of Medicine

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 28, 2017

Study Start

September 2, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

June 25, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)