NCT02090426

Brief Summary

This trial investigates the value created by the highly innovative Camden Coalition of Healthcare Providers' Care Management Program: Link2Care. The program targets "super-utilizers" of the health care system - specifically adults with 2 or more hospitalizations in the last six months 2 or more chronic conditions, and 5 or more outpatient medications - with intensive case management services. In particular, a team of nurses, social workers, community health workers and health coaches, supported by real-time data of healthcare utilization, perform home visits, accompany patients to doctor visits, and help patients enroll in social-service programs. This approach aims to improve the self-sufficiency of patients in navigating the healthcare and social-service systems and has the potential to reduce healthcare costs and improve patient health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 17, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 2, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 11, 2020

Completed
Last Updated

November 19, 2020

Status Verified

October 1, 2020

Enrollment Period

4.3 years

First QC Date

March 17, 2014

Results QC Date

January 10, 2020

Last Update Submit

October 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Any Hospital Readmission

    180-day from indexed hospital discharge

Secondary Outcomes (9)

  • Any Emergency Department Use

    180-day from indexed hospital discharge

  • Any Hospital Use (Inpatient or ED)

    180-day from indexed hospital discharge

  • Inpatient Readmission From the ED

    180-day from indexed hospital discharge

  • Inpatient Readmission Not From the ED

    180-day from indexed hospital discharge

  • Number of Readmissions

    180-day from indexed hospital discharge

  • +4 more secondary outcomes

Other Outcomes (9)

  • Number of Readmissions

    30-day from indexed hospital discharge

  • Number of Readmissions

    90-day from indexed hospital discharge

  • Number of Readmissions

    365-day from indexed hospital discharge

  • +6 more other outcomes

Study Arms (2)

Standard Care

NO INTERVENTION

Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.

Link2Care

EXPERIMENTAL

Participants are assigned to a multidisciplinary care team (Link2Care) comprised of a registered nurse, licensed practical nurse, social worker, intervention specialist, community health worker, and health coaches. A representative from the care team engages with the patient at bedside during the hospital admission and plans for the immediate period following discharge. The Program, as a whole, involves a series of home visits, scheduling of and accompaniment to initial primary care and specialty care visits, and support for individuals as they navigate various social service agencies to enroll in public programs including TANF, SNAP, and programs that promote housing stability.

Other: Link2Care

Interventions

Link2Care

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must satisfy the following criteria based on the records from the index event:
  • Is currently admitted to Cooper or Lourdes hospitals (still in hospital for recruitment)
  • Resides in the following zip codes: 08101 (PO zip code), 08102-08105, 08107s, 08110
  • Is 19-80 years old
  • Has \>=2 hospital admissions in the past 6 months (to Camden area hospitals in the Health Information Exchange )
  • Has \>=2 chronic conditions
  • Patients must meet at least three of the following criteria based largely on the electronic medical record:
  • Has \>=5 outpatient medications
  • Has difficulty accessing services
  • Lacks social support
  • Has mental health co-morbidity
  • Is actively using drugs
  • Is homeless

You may not qualify if:

  • Already subject in RCT (treatment or control)
  • Deceased or discharged prior to triage or recruitment
  • Uninsured
  • Cognitively impaired
  • Oncology patient
  • Index hospitalization is for: a surgical procedure for an acute problem, complications of a progressive chronic disease with limited treatments, or mental health issue only with no co-morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Our Lady of Lourdes Medical Center

Camden, New Jersey, 08103, United States

Location

Related Publications (2)

  • Yang Q, Wiest D, Davis AC, Truchil A, Adams JL. Hospital Readmissions by Variation in Engagement in the Health Care Hotspotting Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332715. doi: 10.1001/jamanetworkopen.2023.32715.

  • Finkelstein A, Zhou A, Taubman S, Doyle J. Health Care Hotspotting - A Randomized, Controlled Trial. N Engl J Med. 2020 Jan 9;382(2):152-162. doi: 10.1056/NEJMsa1906848.

Results Point of Contact

Title
Amy Finkelstein, PhD
Organization
Massachusetts Institute of Technology

Study Officials

  • Amy N Finkelstein, PhD

    The Abdul Latif Jameel Poverty Action Lab/MIT

    PRINCIPAL INVESTIGATOR
  • Jeffery Brenner, MD

    The Cooper Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 18, 2014

Study Start

June 2, 2014

Primary Completion

October 1, 2018

Study Completion

January 1, 2020

Last Updated

November 19, 2020

Results First Posted

March 11, 2020

Record last verified: 2020-10

Locations