A Patient Centered Intervention to Improve Health and Reduce Medicaid Costs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by New York City Health and Hospitals Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier:
NCT01602848
First received: May 17, 2012
Last updated: May 18, 2012
Last verified: June 2011
  Purpose

Medicaid-insured patients with frequent hospitalizations account for a disproportionate share of visits and costs, and have caught the attention of policy makers, creating an impetus for hospitals and health care providers to better understand and control associated expenditures. Many such patients have specific unmet health and social needs. Based on our extensive pilot work with this population, the New York State Department of Health recently awarded the New York City Health and Hospitals Corporation one of seven statewide contracts to implement a Chronic Illness Demonstration Project, aimed at improving care and reducing healthcare expenditures for high cost Medicaid patients. Within this framework, the investigators propose a group-randomized trial design to test whether specific outcomes related to health, functional status, and quality of life resulting from a patient-centered, intensive care coordination and management intervention correlate with improved linkage to primary care while reducing hospitalizations and emergency department visits. The investigators will then relate these benefits to program costs using standard cost-effectiveness analysis techniques. Given that there are few examples of successful interventions for this population and currently unparalleled Medicaid spending, there is an urgent need to demonstrate that interventions to improve care coordination and optimize patients' use of the health and social care system result in more efficient and less costly care.


Condition Intervention
High-risk, High-cost Medicaid Services Users
Other: Intensive care management and coordination
Other: usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Patient Centered Intervention to Improve Health and Reduce Medicaid Costs

Resource links provided by NLM:


Further study details as provided by New York City Health and Hospitals Corporation:

Primary Outcome Measures:
  • The primary outcome is change in health status as measured by the SF-12. [ Time Frame: 6-36 months ] [ Designated as safety issue: No ]
    The SF-12 is a shorter yet comparable version of the SF-36 and is an accepted measure for evaluating treatment effectiveness in clinical trials.45-46 The SF-12 has both a mental and physical health component, and provides both a physical component summary (PCS) score and mental component summary (MCS) score. This type of health measure is ideal for this study population, which has high rates of chronic disease including mental health diagnoses.


Secondary Outcome Measures:
  • changes in ED visits and hospitalizations based on Medicaid claims data provided by the New York State Dept of Health [ Time Frame: 6-36 months ] [ Designated as safety issue: No ]
    We'll evaluate changes in the numbers of ED visits and hospitalizations for enrollees before and after enrollment, and also compare differences between enrollees and those who were eligible for enrollment but not enrolled

  • changes in primary care outpatient care [ Time Frame: 6-36 months ] [ Designated as safety issue: No ]
    For intervention enrollees, we'll evaluate changes in the numbers who report they have a primary care provider before and after enrollment, as well as the number of outpatient primary care visits before and after enrollment

  • self reported health [ Time Frame: 6-36 months ] [ Designated as safety issue: No ]
    changes in self-reported health using the SF-12 for intervention enrollees comparing the baseline report at time of enrollment to 6-12 month intervals after enrollment


Estimated Enrollment: 1000
Study Start Date: August 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention enrollee
HIgh risk fee for service Medicaid recipients identified as eligible by the New York State Dept of Health and enrolled in the intensive care management and coordination intervention
Other: Intensive care management and coordination
Care Management Teams comprised of social workers, community based care managers, and dedicated clinicians work to meet patients' needs in both the health care setting and the community. The CIDP model incorporates motivational interviewing, harm reduction, access to housing through our community partners utilizing a Housing First approach, and provides cellular phones for patients when needed, to better enable regular communication with program staff.
No Intervention: Eligible, not enrolled
Medicaid fee-for-service patients who are identified as eligible for the intervention but are not enrolled. These patients receive usual services provided by Medicaid.
Other: usual care
usual care including services for which patients are eligible via fee for service medicaid

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Fee-for-service Medicaid over age 18 identified as high-risk (risk score over 30 based on validated case-finding algorithm) by the New York State Department of Health, residing in pre-specified zip codes in the HHC catchment area

Exclusion Criteria:

Medicaid enrollees who are not fee-for-service Under age 18

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602848

Locations
United States, New York
New York City Health and Hospitals Corporation Central Office, Office of Medical and Professional Affairs
New York, New York, United States, 10012
Sponsors and Collaborators
New York City Health and Hospitals Corporation
New York State Department of Health
Investigators
Principal Investigator: Maria C Raven, MD, MPH, MSc NYU SOM, HHC, UCSF
  More Information

Publications:
Responsible Party: New York City Health and Hospitals Corporation
ClinicalTrials.gov Identifier: NCT01602848     History of Changes
Other Study ID Numbers: 09-08-243-05-G
Study First Received: May 17, 2012
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York City Health and Hospitals Corporation:
Medicaid
frequent users
heavy users
high risk
high cost
intervention to improve care and reduce Medicaid expenditures

ClinicalTrials.gov processed this record on October 29, 2014