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Health Care Hotspotting: A Randomized Controlled Trial
Last registered on June 17, 2017

Pre-Trial

Trial Information
General Information
Title
Health Care Hotspotting: A Randomized Controlled Trial
RCT ID
AEARCTR-0000329
Initial registration date
March 31, 2014
Last updated
June 17, 2017 10:31 AM EDT
Location(s)

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Primary Investigator
Affiliation
MIT
Other Primary Investigator(s)
PI Affiliation
PhD Program in Health Policy, Harvard University
PI Affiliation
Department of Family Medicine, Cooper Health System
PI Affiliation
Massachusetts Institute of Technology
PI Affiliation
National Bureau of Economic Research
Additional Trial Information
Status
In development
Start date
2014-03-26
End date
2020-07-01
Secondary IDs
ClinicalTrials.gov NCT02090426
Abstract
This randomized trial investigates the impact of the 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 and 2 or more chronic conditions - with intensive care-management services in the one to three months following hospital discharge. 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. Through random assignment to the intervention, we plan to study the impact of the Link2Care program, particularly on subsequent hospital use.
Registration Citation
Citation
Doyle, Joseph et al. 2017. "Health Care Hotspotting: A Randomized Controlled Trial." AEA RCT Registry. June 17. https://doi.org/10.1257/rct.329-2.0
Former Citation
Doyle, Joseph et al. 2017. "Health Care Hotspotting: A Randomized Controlled Trial." AEA RCT Registry. June 17. https://www.socialscienceregistry.org/trials/329/history/18781
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Experimental: Link2Care
Link2Care provides intensive care management and coordination for up to 6 months following hospital discharge. 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.

No Intervention: Standard Care
Individuals in the standard care arm receive standard discharge planning from the hospital with no followup by Link2Care team members.
Intervention Start Date
2014-03-26
Intervention End Date
2017-10-01
Primary Outcomes
Primary Outcomes (end points)
Any hospital readmission; Any emergency department use; Any hospital use (inpatient or ED); Inpatient readmission from the ED; Inpatient readmission not from the ED; Number of readmissions; Had 2+ readmissions; Number of days in the hospital; Hospital charges; Hospital receipts.
Primary Outcomes (explanation)
We are interested in measuring effects in the short-term while the program is actively providing services (30-days, 90-days), and longer-term outcomes (180-days, 365 days).
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The Link2Care program targets patients in Camden, New Jersey hospitals who have had at least two hospital admissions in the prior six months and have at least two chronic conditions. Enrollment in the trial will be conducted by CCHP in a process similar to the one currently used to enroll patients into Link2Care. Patients will be enrolled at the two major Camden hospitals: Cooper University Hospital and Our Lady of Lourdes.

Identification of eligible patients will rely on a Health Information Exchange (HIE) that CCHP helped to develop. Patients must satisfy the following criteria based on the records at the time of the index event:

• Is currently admitted to Cooper or Lourdes hospitals (still in hospital for recruitment)
• Is 19-80 years old
• Resides in the following ZIP codes: 08101 (PO ZIP code), 08102-08105, 08107
• Has >=2 hospital admissions in the past 6 months (to hospitals in the HIE3)
• 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 a mental health co-morbidity
• Is actively using drugs
• Is homeless

Patients will be excluded if they meet any of the following criteria:
• Already a subject in the 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
– A mental health issue only with no co-morbid conditions

A CCHP recruiter will approach individuals deemed eligible before the candidate is discharged from the hospital. The recruiter will explain the purpose, process, risks and benefits of the study, including the randomization process and intervention.
Experimental Design Details
Not available
Randomization Method
Random number generator by computer.
Randomization Unit
Individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
n/a
Sample size: planned number of observations
800 individuals
Sample size (or number of clusters) by treatment arms
400 treatment, 400 control
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We determined that with 80% power and a test size of 0.05, a sample size of 800 would provide the statistical power to detect a 30% reduction in our primary outcome: 180-day hospital readmission. Compared to the mean 180-day readmission rate of 0.30, this means that we would have the power to detect a drop to 0.21. Although this is a large effect, it is within the set of estimates found in the literature for intensive case management featuring home visits described in the literature review. Another 180-day outcome where we would have the power to detect a 30% decline is the likelihood of 2 or more “hospital visits”, defined as outpatient ED visits plus inpatient readmissions, which averages 0.32. Other 180-day outcomes where we have the power to detect a 20% change include any hospital visit (an outcome that averages 0.54) and the likelihood of any outpatient ED visit (an average of 0.42). If we have the power to detect a given percentage change in an outcome at six months, we have the power to detect an effect at twelve months as well (e.g. 365-day readmission). Other outcomes where we have the power to detect a 30% decline over the following 365 days include the number of hospital visits (which averages 2.7) and the likelihood of 3 or more visits (which averages 0.33). As a result of these power calculations, we plan to recruit until we attain a sample size of 800 subjects.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Harvard University-Area (ceding to Cooper University Hospital)
IRB Approval Date
2014-03-03
IRB Approval Number
IRB14-0179
IRB Name
NATIONAL BUREAU OF ECONOMIC RESEARCH, INC.
IRB Approval Date
2014-03-07
IRB Approval Number
FWA #00003692
IRB Name
MIT COUHES (ceding to Cooper University Hospital)
IRB Approval Date
2014-03-08
IRB Approval Number
FWA00004881
IRB Name
Cooper University Hospital Institutional Review Board Office
IRB Approval Date
2014-02-14
IRB Approval Number
13-171EX
Analysis Plan
Analysis Plan Documents
Health Care Hotspotting- A Randomized Controlled Trial Analysis Plan - Analysis Plan - 2014-03-07.pdf

MD5: 80aaeff234d209b3c94d3562cb2a93dc

SHA1: 191d7aefbde68c4e14f39f25b36f591da0a338ca

Uploaded At: March 26, 2014