Chronic IllnessNCT00399373
Structuring the Integration of Care Management Services For Medicaid Enrollees Recipients With Chronic Illness, Substance Abuse Problems and Possible Psychiatric Disorders
An observational study of Chronic Illness, run by Johns Hopkins University at 1 site in United States.
Trial summary
The study seeks to measure the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Illness
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Oct 2008
- Phase
- Observational
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We determined the size of the quality improvement initiative sample by the case management resources available at JHHC. Without adding personnel, the maximum number of new cases that can be assumed by the 3.5 (FTE) JHHC case managers for the Eastern Shore is 130.
Who may be able to join
- 21 years of age or older;
- Resident of one of the following Maryland counties: Caroline, Cecil, Kent, Queen Anne's, Talbot, Dorchester, Somerset, Wicomico, Worcester, Allegheny, Frederick, Garrett, Washington, Calvert, Charles, or St. Mary's; or
- Chronic medical condition(s) identified by ACG Case Mix software (e.g. an ACG score => 0.10) as likely to incur high costs in the following year; and
- Substance use problem in the past 27 months as indicated by an ICD-9 code or CPT code on DHMH list for Special Needs Population.
Who cannot join
- 1) Enrolled in or eligible for enrollment in a Special Needs disease management program at JHHC: HIV/AIDS, Partners with Mom, Omega Life. It is necessary to exclude these programs because PPMCO members are already receiving intensive care management.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins HealthCare LLC
Glen Burnie, Maryland, 21060
About this study
Official title: Structuring the Integration of Services For Medicaid Recipients With Chronic Illness, Substance Abuse Problems and Possible Psychiatric Disorders
The study seeks to measure the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
Read the detailed description
Problem in context. In an environment of increased competition for governmental funding, Medicaid programs in every state are bracing for decreased resources being available for the care of their enrollees. A possible result of less funding is reduced quality of healthcare. In response to this threat, The Center for Health Care Strategies, Inc, (CHCS) a non-profit organization dedicated to improving the quality of publicly financed health care, issued an RFP for participation in a multisite project to expand or enhance existing efforts to improve the way care for Medicaid enrollees with multiple chronic conditions is delivered, integrated, measured and financed.
Present knowledge. While there is strong documentation of improved population health status with care management, the evidence for the immediate economic effects of care management initiatives is mixed for commercial and absent for Medicaid populations. CHCS is presently conducting a multisite study (in which we participate) of whether or not a business case (return on investment) can be made for quality improvement initiatives in a Medicaid population.
Research question. What is the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
The primary goal of the project will be to improve the coordination of medical, substance abuse and mental health services for a group of Medicaid beneficiaries with chronic medical conditions. We hypothesize that the recipients of integrated care management (on the Eastern Shore) will have lower total medical costs (pharmacy, inpatient and outpatient), higher utilization of mental health and substance abuse services and lower use of emergency department services than those who received customary care (in western Maryland).
The secondary goal of this project will be to assist in the further development and piloting of information systems within MHA that will facilitate sharing of clinical information necessary for the coordination of behavioral (mental health and substance abuse) and medical care management between a Medicaid MCO (JHHC's PPMCO) and the mental health carve-out ASO, MAPS-MD. The outcome measurement for the secondary objective will be the extent to which an information system for coordination of care and population based queries has been established within MHA and is, with proper oversight by MHA, accessible to responsible entities.
Significance. The project targets a vulnerable population within Medicaid enrollees that are challenged when accessing care and are responsible for high total medical costs. The results of the project should be helpful to other the MCOs in Maryland's Health Partners, as well as to states with similar Medicaid systems as they seek to provide integrated healthcare services to their populations.
- Conditions
- Chronic Illness
- Keywords
- disease management, substance abuse
- Medical subject headings
- Chronic Disease, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Quality Improvement Initiative | The initial step in the quality improvement initiative was a letter sent from JHHC Care Management Department to the quality improvement initiative group, inviting them to take advantage of the case management services that are part of their current benefits in the Priority Partners MCO. It is similar to the standard letter sent to PPMCO members who are appropriate for a JHHC disease or case management program. A substance abuse outreach staff initiated telephonic contact with the members in the intervention group. The staff member then refered to substance abuse treatment when possible and appropriate and refered to medical case management. | |
| Control group | No additional improvement modalities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total medical costs (per member per month)
Measured: monthly average, calculated at the end of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter J Fagan, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399373
- Sponsor's protocol ID
- NA_00001352
- Other IDs
- 100326 (CHCS)
- Status last verified
- Dec 2017
- First submitted
- 13 Nov 2006
- Last updated
- 7 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structuring the Integration of Services For Medicaid Recipients With Chronic Illness, Substance Abuse Problems and Possible Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT00399373
- Acronym / sponsor ID
- NA_00001352
- Conditions
- Chronic Illness
- Keywords
- disease management, substance abuse
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 Nov 2006 (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.
The study seeks to measure the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
Detailed description
Problem in context. In an environment of increased competition for governmental funding, Medicaid programs in every state are bracing for decreased resources being available for the care of their enrollees. A possible result of less funding is reduced quality of healthcare. In response to this threat, The Center for Health Care Strategies, Inc, (CHCS) a non-profit organization dedicated to improving the quality of publicly financed health care, issued an RFP for participation in a multisite project to expand or enhance existing efforts to improve the way care for Medicaid enrollees with multiple chronic conditions is delivered, integrated, measured and financed.
Present knowledge. While there is strong documentation of improved population health status with care management, the evidence for the immediate economic effects of care management initiatives is mixed for commercial and absent for Medicaid populations. CHCS is presently conducting a multisite study (in which we participate) of whether or not a business case (return on investment) can be made for quality improvement initiatives in a Medicaid population.
Research question. What is the effect of increased coordination of care on medical costs, treatment utilization and selected clinical indicators among a Medicaid population with chronic medical conditions and substance abuse problems? We shall address this question by conducting a demonstration project consisting of the provision of integrated care management (somatic and behavioral) to Medicaid enrollees living on the Eastern Shore of Maryland and who have both chronic medical conditions and problems with substance abuse. A specific component of the study will be the participation of Maryland's Mental Health Administration (MHA) and MAPS, the administrator of psychiatric services for the Medicaid enrollees in Maryland. We shall compare the results of the integrated care management for the study sample on the Eastern Shore with a control group from the counties of western Maryland.
The primary goal of the project will be to improve the coordination of medical, substance abuse and mental health services for a group of Medicaid beneficiaries with chronic medical conditions. We hypothesize that the recipients of integrated care management (on the Eastern Shore) will have lower total medical costs (pharmacy, inpatient and outpatient), higher utilization of mental health and substance abuse services and lower use of emergency department services than those who received customary care (in western Maryland).
The secondary goal of this project will be to assist in the further development and piloting of information systems within MHA that will facilitate sharing of clinical information necessary for the coordination of behavioral (mental health and substance abuse) and medical care management between a Medicaid MCO (JHHC's PPMCO) and the mental health carve-out ASO, MAPS-MD. The outcome measurement for the secondary objective will be the extent to which an information system for coordination of care and population based queries has been established within MHA and is, with proper oversight by MHA, accessible to responsible entities.
Significance. The project targets a vulnerable population within Medicaid enrollees that are challenged when accessing care and are responsible for high total medical costs. The results of the project should be helpful to other the MCOs in Maryland's Health Partners, as well as to states with similar Medicaid systems as they seek to provide integrated healthcare services to their populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quality Improvement Initiative | – | –The initial step in the quality improvement initiative was a letter sent from JHHC Care Management Department to the quality improvement initiative group, inviting them to take advantage of the case management services that are part of their current benefits in the Priority Partners MCO. It is similar to the standard letter sent to PPMCO members who are appropriate for a JHHC disease or case management program. A substance abuse outreach staff initiated telephonic contact with the members in the intervention group. The staff member then refered to substance abuse treatment when possible and appropriate and refered to medical case management. |
| Control group | – | –No additional improvement modalities |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We determined the size of the quality improvement initiative sample by the case management resources available at JHHC. Without adding personnel, the maximum number of new cases that can be assumed by the 3.5 (FTE) JHHC case managers for the Eastern Shore is 130.
Key inclusion criteria (4 listed)
- 21 years of age or older;
- Resident of one of the following Maryland counties: Caroline, Cecil, Kent, Queen Anne's, Talbot, Dorchester, Somerset, Wicomico, Worcester, Allegheny, Frederick, Garrett, Washington, Calvert, Charles, or St. Mary's; or
- Chronic medical condition(s) identified by ACG Case Mix software (e.g. an ACG score => 0.10) as likely to incur high costs in the following year; and
- Substance use problem in the past 27 months as indicated by an ICD-9 code or CPT code on DHMH list for Special Needs Population.
Key exclusion criteria (1 listed)
- 1) Enrolled in or eligible for enrollment in a Special Needs disease management program at JHHC: HIV/AIDS, Partners with Mom, Omega Life. It is necessary to exclude these programs because PPMCO members are already receiving intensive care management.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total medical costs (per member per month)
Time frame: monthly average, calculated at the end of 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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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.
Peter J Fagan, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Illness, run by Johns Hopkins University 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 4 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: stopped early, as of the sponsor's last update on 7 Dec 2017. 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 was stopped early. Results are not available in the source record.
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?
Total medical costs (per member per month) (time frame: monthly average, calculated at the end of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2017.