Overview

This trial is active, not recruiting.

Condition high-risk, high-cost medicaid services users
Treatments intensive care management and coordination, usual care
Sponsor New York City Health and Hospitals Corporation
Collaborator New York State Department of Health
Start date August 2009
End date September 2011
Trial size 1000 participants
Trial identifier NCT01602848, 09-08-243-05-G

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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
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)
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.
usual care
usual care including services for which patients are eligible via fee for service medicaid

Primary Outcomes

Measure
The primary outcome is change in health status as measured by the SF-12.
time frame: 6-36 months

Secondary Outcomes

Measure
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
changes in primary care outpatient care
time frame: 6-36 months
self reported health
time frame: 6-36 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Patient Centered Intervention to Improve Health and Reduce Medicaid Costs
Principal investigator Maria C Raven, MD, MPH, MSc
Description Though patients with frequent hospital admissions comprise a small percentage of all patients, they account for a disproportionate share of visits and costs. Their substantial use of health care resources is often a result of the simultaneous presence of severe medical and social co-morbidities. These high cost cases have caught the attention of policy makers, and have created a movement by states to shift Medicaid patients from fee-for-service into managed care models or "high risk" case management programs. Such state initiatives create an impetus for hospitals and health care providers to better understand and control expenditures for the highest users of health services. The work proposed for this application will address this gap in the literature through the use of a group-randomized trial design using quantitative to evaluate outcomes. This proposal is a logical extension of our previous work: for the past three years, we have been conducting research on improving care coordination for this patient population via in-depth needs assessment, model program development, and implementation of a pilot initiative at a safety net hospital for a limited number of patients to determine feasibility. Most recently, the New York City Health and Hospitals Corporation (HHC) was awarded one of seven New York State Department of Health Chronic Illness Demonstration Project (CIDP) grants of over $5 million and spanning 3 years, to expand this work to enroll and intervene with similar high-risk patients throughout the system. In order to evaluate the impact of the CIDP initiative, the intervention is currently designed as a group-randomized trial that will track and compare the health care utilization and costs in intervention and control groups using Medicaid claims data. However, no provision has been made for contacting or characterizing control group members, or for surveying control group members regarding issues such as depression, social support, behavioral health needs, or satisfaction with current care, leaving the question of which intervention components correlate with changes in health services utilization unanswered. The ability of the evaluation to analyze the effect of important factors we anticipate will be improved by this innovative care redesign initiative (e.g., social support, housing status) on health services utilization is thus sharply curtailed, limiting the outcomes being studied to those derivable from administrative claims data. We thus propose to conduct an in-depth evaluation of the HHC CIDP enrollees to determine 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. We will then relate these benefits to program costs using standard cost-effectiveness analysis techniques. Our program model is innovative in its approach, employing Care Management Teams comprised of social workers, community based care managers, and dedicated clinicians who work to meet patients' needs in both the health care setting and the community. Specific Aim 1 To compare changes in outcomes related to health status, quality of life, and care satisfaction between high-risk intervention patients and controls using quantitative and qualitative methods. Associated hypotheses Compared to baseline assessments administered at the time of enrollment, 1.1 Intervention patients will have measurable improvements in health status as measured by the SF-12 and the PHQ-9 at 12-month follow-up. Enrollees will have measurable improvements in quality of life as measured by the Perceived Availability of Support scale, the CHAOS scale, and housing status at 12- and 24-month follow-up. 1.2 Intervention patients will have measurable improvements in personal satisfaction with health care as measured by the PSQ-18 at 12 and 24-month follow-up. Specific Aim 2 To determine if improvements in linkage to primary care (defined as 3 visits to the same clinic within 12 months), and reduced use of acute care services (emergency department visits and hospital admissions) are associated with improved health status, quality of life, and personal satisfaction with health care . Associated hypotheses 2.1 Improvements in measures of health status are associated with improved linkage to primary care and reductions in use of acute care services. 2.2 Improvements in measures of quality of life are associated with improved linkage to primary care and reductions in use of acute care services. 2.3 Improvements in measures of personal satisfaction are associated with improved linkage to primary care and reductions in use of acute care services. Specific Aim 3 To understand the economic impact of the intervention by measuring its component financial and societal costs, and to perform a cost- effectiveness analysis for primary and secondary outcomes. Associated hypotheses 3.1 The overall reduction in health care costs will meet or exceed the cost of the intervention accounting for all intervention-related costs. 3.2 The intervention will have favorable value compared to alternative uses of healthcare resources for this priority population. 3.2.a. The cost of the intervention per hospitalization averted (and associated mortality) will be favorable. 3.2.b The cost of the intervention per improvement in QALY will be favorable
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by New York City Health and Hospitals Corporation.