High-risk, High-cost Medicaid Services UsersNCT01602848
A Patient Centered Intervention to Improve Health and Reduce Medicaid Costs
A study testing Intensive care management and coordination in people with High-risk, High-cost Medicaid Services Users, run by New York City Health and Hospitals Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk, High-cost Medicaid Services Users
- What is being tested?
- Intensive care management and coordination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to 1 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medicaid enrollees who are not fee-for-service Under age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
New York City Health and Hospitals Corporation Central Office, Office of Medical and Professional Affairs
New York, New York, 10012
About this study
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.
Read the detailed 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
- Being tested
- Intensive care management and coordination
- Keywords
- Medicaid, frequent users, heavy users, high risk, high cost, intervention to improve care and reduce Medicaid expenditures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive care management and coordinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention enrollee | 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 Receives: Other: Intensive care management and coordination |
| Eligible, not enrolled | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is change in health status as measured by the SF-12.
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.
Measured: 6-36 months
Secondary outcomes (3)
changes in ED visits and hospitalizations based on Medicaid claims data provided by the New York State Dept of Health
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
Measured: 6-36 months
changes in primary care outpatient care
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
Measured: 6-36 months
self reported health
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
Measured: 6-36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completion1 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High-risk, High-cost Medicaid Services UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York City Health and Hospitals Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health
- Responsible party
- Sponsor
- Investigators
- Maria C Raven, MD, MPH, MSc, Principal investigator, NYU SOM, HHC, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602848
- Sponsor's protocol ID
- 09-08-243-05-G
- Status last verified
- Apr 2018
- First submitted
- 17 May 2012
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Raven MC, Billings JC, Goldfrank LR, Manheimer ED, Gourevitch MN. Medicaid patients at high risk for frequent hospital admission: real-time identification and remediable risks. J Urban Health. 2009 Mar;86(2):230-41. doi: 10.1007/s11524-008-9336-1. Epub 2008 Dec 12.
PubMed 19082899Raven MC, Carrier ER, Lee J, Billings JC, Marr M, Gourevitch MN. Substance use treatment barriers for patients with frequent hospital admissions. J Subst Abuse Treat. 2010 Jan;38(1):22-30. doi: 10.1016/j.jsat.2009.05.009. Epub 2009 Jun 21.
PubMed 19540700Billings J, Mijanovich T. Improving the management of care for high-cost Medicaid patients. Health Aff (Millwood). 2007 Nov-Dec;26(6):1643-54. doi: 10.1377/hlthaff.26.6.1643.
PubMed 17978384
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient Centered Intervention to Improve Health and Reduce Medicaid Costs
- ClinicalTrials.gov ID
- NCT01602848
- Acronym / sponsor ID
- 09-08-243-05-G
- Keywords
- Medicaid, frequent users, heavy users, high risk, high cost, intervention to improve care and reduce Medicaid expenditures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- New York City Health and Hospitals CorporationUniversity, hospital or other
- Collaborators
- New York State Department of Health
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- 1 Nov 2013 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention enrollee | Experimental | Other: Intensive care management and coordinationHIgh 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 |
| Eligible, not enrolled | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Medicaid enrollees who are not fee-for-service Under age 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive care management and coordinationCare 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. | Other | Intervention enrollee |
Primary outcome
The primary outcome is change in health status as measured by the SF-12.
Time frame: 6-36 months
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Background: PubMed 19082899Raven MC, Billings JC, Goldfrank LR, Manheimer ED, Gourevitch MN. Medicaid patients at high risk for frequent hospital admission: real-time identification and remediable risks. J Urban Health. 2009 Mar;86(2):230-41. doi: 10.1007/s11524-008-9336-1. Epub 2008 Dec 12.
- Background: PubMed 19540700Raven MC, Carrier ER, Lee J, Billings JC, Marr M, Gourevitch MN. Substance use treatment barriers for patients with frequent hospital admissions. J Subst Abuse Treat. 2010 Jan;38(1):22-30. doi: 10.1016/j.jsat.2009.05.009. Epub 2009 Jun 21.
- Background: PubMed 17978384Billings J, Mijanovich T. Improving the management of care for high-cost Medicaid patients. Health Aff (Millwood). 2007 Nov-Dec;26(6):1643-54. doi: 10.1377/hlthaff.26.6.1643.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria C Raven, MD, MPH, MSc principal investigator
NYU SOM, HHC, UCSF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive care management and coordination in people with High-risk, High-cost Medicaid Services Users, run by New York City Health and Hospitals Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is change in health status as measured by the SF-12. (time frame: 6-36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018.