Clinical trial NCT02090426: Health Care Hotspotting: A Randomized Controlled Trial
Official title: Health Care Hotspotting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Utilizers of Hospital Care
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: The Cooper Health System
name: National Bureau of Economic Research, Inc.
name: Massachusetts Institute of Technology
name: Harvard University
First posted: 2014-03-18
Enrollment: 800
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The Camden Coalition of Healthcare Providers' Care Management Program, Link2Care, targets "super-utilizers" of the health care system. These are individuals with medically and socially complex needs who have frequent hospital admissions. Specifically, the Link2Care program targets patients in specific Camden hospitals who have had at least two hospital admissions in the last six months and have at least two chronic conditions.

Such heavy utilizers of hospital care account for a disproportionate share of healthcare spending. For example, CCHP analyzed hospital admission and emergency department use at three Camden hospital systems from 2002-2007 and found that 20% of patients accounted for 90% of the costs (Green et al., 2010). As described below, when we compare patients admitted to Camden hospitals, in the year prior to an admission, a typical patient targeted by the program has 2.5 times more admissions in the prior six months due to the targeting. They are also much more likely to be readmitted to the hospital over the year following the hospital stay, accruing $73,000 in hospital charges over that time compared to $6600 for other patients.

Link2Care provides intensive care management and coordination for up to 6 months following hospital discharge. From October 2012 to January 2014, the median length of the intervention for those who completed it was 85 days.

The approach aims to improve the self-sufficiency of patients in navigating the healthcare and social-service systems. It has the potential to reduce healthcare costs and improve patient health, as patients learn to use primary care to prevent an escalation of symptoms that leads to rehospitalization.

Participants are assigned to a multidisciplinary care team 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. Link2Care, 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.

The patient is enrolled in the program while still in the hospital. Upon discharge, the care team works to visit the patient at home within 3 days of discharge. The care team also works to schedule a primary care visit within 7 days of discharge, and appropriate specialist visits as necessary At the initial home visit, the care team (1) performs medication reconciliation-an inventory of the medications prescribed to gauge appropriateness and patient understanding, (2) conducts an assessment of the patient's perception of the discharge experience and care coordination, medical/health needs, activity/mobility, service needs, and stage of readiness to change, and (3) collaboratively sets goals with the individual, such as compliance with the discharge plan. The care team then works closely with the patient to achieve these goals; as is needed, the team assists the patient in scheduling necessary physician visits, accompanies the patient to those visits, completes applications for social services, and coaches the patient in self-care. Subsequent home visits evaluate the patient's and the team's progress. The end of the intervention is determined based on hospital utilization, individual factors (health education/literacy, disease self-management, skills development, level of engagement, self-efficacy) and some systemic factors (access to, and the quality of, care, social support, etc.). The person receives a graduation certificate. The person is expected to meet their healthcare needs in the future through their primary care physician.

In an earlier, non-randomized evaluation, this program has been found to improve health outcomes, decrease utilization of emergency and inpatient services, and decrease costs for a cohort of 36 "high utilizers" from $1.2 million monthly to $534,000 monthly, a savings of 56% over five years (Green et al., 2010).

Due to staff and financial constraints, Link2Care is currently administered for only a subset of the patients who meet the eligibility criteria, and the patients who are currently approached are chosen in an ad-hoc manner. This study would establish a formal process for determining - via random assignment - which subset of eligible individuals are offered the intervention. This random assignment, which will not reduce the number of individuals who benefit from the services, will allow us to isolate the causal effects of the CCHP Link2Care Program.

Eligibility 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

Primary outcomes:
measure: Any Hospital Readmission
timeFrame: 180-day from indexed hospital discharge
Secondary outcomes:
measure: Any Emergency Department Use
timeFrame: 180-day from indexed hospital discharge
measure: Any Hospital Use (Inpatient or ED)
timeFrame: 180-day from indexed hospital discharge
measure: Inpatient Readmission From the ED
timeFrame: 180-day from indexed hospital discharge
measure: Inpatient Readmission Not From the ED
timeFrame: 180-day from indexed hospital discharge
measure: Number of Readmissions
timeFrame: 180-day from indexed hospital discharge
measure: Had 2+ Readmissions
timeFrame: 180-day from indexed hospital discharge
measure: Number of Days in the Hospital
timeFrame: 180-day from indexed hospital discharge
measure: Hospital Charges
timeFrame: 180-day from indexed hospital discharge
measure: Hospital Receipts
timeFrame: 180-day from indexed hospital discharge
Other outcomes:
measure: Number of Readmissions
timeFrame: 30-day from indexed hospital discharge
measure: Number of Readmissions
timeFrame: 90-day from indexed hospital discharge
measure: Number of Readmissions
timeFrame: 365-day from indexed hospital discharge
measure: Any Hospital Use (Inpatient or ED)
timeFrame: 365-day from indexed hospital discharge
measure: Time to Readmission (Days)
timeFrame: Up to 365 days from indexed hospital discharge
measure: Number of Readmissions (for Patients With 3+ Readmissions in the Prior Year)
timeFrame: 180-day from indexed hospital discharge
measure: Number of Readmissions (for Patients With 2 Readmissions in the Prior Year)
timeFrame: 180-day from indexed hospital discharge
measure: Number of Readmissions (for English Speaking Patients)
timeFrame: 180-day from indexed hospital discharge
measure: Number of Readmissions (for Non-English Speaking Patients)
timeFrame: 180-day from indexed hospital discharge
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
Study officials:
affiliation: The Abdul Latif Jameel Poverty Action Lab/MIT
name: Amy N Finkelstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cooper Health System
name: Jeffery Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.