ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Care Hotspotting: A Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02090426
Recruitment Status : Recruiting
First Posted : March 18, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
The Cooper Health System
National Bureau of Economic Research, Inc.
Massachusetts Institute of Technology
Harvard University
Information provided by (Responsible Party):
Abdul Latif Jameel Poverty Action Lab

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.

Condition or disease Intervention/treatment Phase
High Utilizers of Hospital Care Other: Link2Care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Health Care Hotspotting: A Randomized Controlled Trial
Study Start Date : March 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Standard Care
Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
Experimental: Link2Care
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



Primary Outcome Measures :
  1. Any hospital readmission [ Time Frame: 180-day from indexed hospital discharge ]

Secondary Outcome Measures :
  1. Any emergency department use [ Time Frame: 180-day from indexed hospital discharge ]
  2. Any hospital use (inpatient or ED) [ Time Frame: 180-day from indexed hospital discharge ]
  3. Inpatient readmission from the ED [ Time Frame: 180-day from indexed hospital discharge ]
  4. Inpatient readmission not from the ED [ Time Frame: 180-day from indexed hospital discharge ]
  5. Number of readmissions [ Time Frame: 180-day from indexed hospital discharge ]
  6. Had 2+ readmissions [ Time Frame: 180-day from indexed hospital discharge ]
  7. Number of days in the hospital [ Time Frame: 180-day from indexed hospital discharge ]
  8. Hospital charges [ Time Frame: 180-day from indexed hospital discharge ]
  9. Hospital receipts [ Time Frame: 180-day from indexed hospital discharge ]

Other Outcome Measures:
  1. Number of readmissions [ Time Frame: 30-day from indexed hospital discharge ]
  2. Number of readmissions [ Time Frame: 90-day from indexed hospital discharge ]
  3. Number of readmissions [ Time Frame: 365-day from indexed hospital discharge ]
  4. Any hospital use (inpatient or ED) [ Time Frame: 365-day from indexed hospital discharge ]
  5. Time to readmission (days) [ Time Frame: Up to 365 days from indexed hospital discharge ]
  6. Number of readmissions (for patients with 3+ readmissions in the prior year) [ Time Frame: 180-day from indexed hospital discharge ]
  7. Number of readmissions (for patients with 2 readmissions in the prior year) [ Time Frame: 180-day from indexed hospital discharge ]
  8. Number of readmissions (for English speaking patients) [ Time Frame: 180-day from indexed hospital discharge ]
  9. Number of readmissions (for non-English speaking patients) [ Time Frame: 180-day from indexed hospital discharge ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02090426


Contacts
Contact: Aaron Truchil, MSc aaron@camdenhealth.org

Locations
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Our Lady of Lourdes Medical Center Not yet recruiting
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Abdul Latif Jameel Poverty Action Lab
The Cooper Health System
National Bureau of Economic Research, Inc.
Massachusetts Institute of Technology
Harvard University
Investigators
Principal Investigator: Amy N Finkelstein, PhD The Abdul Latif Jameel Poverty Action Lab/MIT
Principal Investigator: Jeffery Brenner, MD The Cooper Health System

Responsible Party: Abdul Latif Jameel Poverty Action Lab
ClinicalTrials.gov Identifier: NCT02090426     History of Changes
Other Study ID Numbers: JPAL-763
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018