HIV InfectionsNCT00577811
Evaluation of Enrollment, Dynamics of Care and Patient Outcomes in the NYS Medicaid HIV Special Needs Plans
An observational study of HIV Infections and Mental Health, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to find out how people's needs are being met and what people do about problems with treatment, symptoms, substance use, mental health, and social services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Mental Health
- How many people
- 628 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to Jan 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The NYSDOH AIDS Institute will obtain Case Report Forms from Special Need Plans. and if they have agreed to receive mail and/or telephone calls regarding the plan they have signed up for. All patients will be informed at the time they join a Special Needs Plan that they may be contacted by evaluators working with the NYSDOH AIDS Institute who willwant to ask them about enrollment and care in the plan. Patients who have not agreed to receive mail will only be contacted by telephone.At this time, a call will be made to conduct screening using the Enrollment module and ask the selected Special Needs Plan patient about their willingness toparticipate in the study.
Who may be able to join
- PWHA must meet the following criteria:
- Medicaid Special Needs Plans or Fee For Service as health insurance at the timeof enrollment;
- Age 18 years or older
- A current resident of New York State
- Able to respond to interview questions in English or Spanish.
- Express willingness and ability to complete a series of one-hour long interviews (interviews may be completed over two telephone sessions, if PWHAs prefer)
- Have cognitive and physical capacity to comprehend and complete the informed consent
Who cannot join
- Enrollment onto the study at an earlier site (we may encounter the same PWHA at more than one FFS recruitment site) • Staff members from Special Needs Plans or FFS Recruitment site determine that it is inadvisable to refer a PWHA to this study for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Slaon-Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to find out how people's needs are being met and what people do about problems with treatment, symptoms, substance use, mental health, and social services. We are also interested in finding out about changes that people make in their health care team and the reasons for making those changes.
Read the detailed description
This is a longitudinal study to examine access to care, perceived quality of life, member satisfaction and patient-reported outcomes among HIV+ adult Medicaid recipients. Special Needs Plans represent a new approach to managed care tailored to patients with complicated medical and psychosocial problems,requiring a high level of service. These plans combine HIV primary and specialty care, mental health services, substance use treatment, care for dependent children and social services into a single comprehensive program that also includes comprehensive case management and other provisions to retain patients in care. Special Needs Plans represent an alternative to both, Medicaid Fee for Service (FFS) and to mainstream Medicaid managed care.Seven different Special Needs Plans will be implemented, serving in New York City and the surrounding suburbs. A separate non-profit corporation administers each SpecialNeeds Plan. Each plan encompasses a network of hospitals, providers, and communitybased organizations. Although all plans offer many of the same basic services, they differ in terms of organization and coordination of care, approaches to case management,specific program enhancements (e.g., patient education, wellness programs, or complementary medicine) and special provisions to meet the needs of subgroups of patients (e.g., women, substance users, young gay men, Latinos). The HIV Special Needs Plans represent an innovation in health service delivery and financing that is being evaluated as a national model for Medicaid service delivery by the federal government, including HRSA and HCFA. This protocol represents a component of that evaluation,from the patients' perspective.This study is being conducted in collaboration with the New York State Department of Health (NYSDOH) AIDS Institute. As a component of their Quality Management and Improvement Programs, Special Need Plans have agreed to assist with recruitment of participants to this evaluation. We will recruit 120 patients sampled from each of the six plans and follow these patients for initially a year with a possibility of continuing to interview them for up to two years. We will also recruit a sample of 360 current Medicaid fee for service patients to serve as comparison group. This sampling strategy will allow us to examine experiences in care and outcomes for different subgroups of patients within the plans, distinguish the affects of service differences among the plans and compare different plan enrollees to similar patients who remain in the Medicaid FFS program. Our longitudinal design will also permit us to examine prospective influences on comparison group patients' decisions to switch their coverage from Medicaid FFS to Special Needs Plans.
- Conditions
- HIV Infections, Mental Health
- Keywords
- Special Need Plans, Fee for Services, Access to Care, Medicaid
- Medical subject headings
- HIV Infections, Psychological Well-Being
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 |
|---|---|---|
| 1 | Patients from 6 different Special Need Plans | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study makes use of several new assessment approaches designed to provide a more in depth understanding of access to care, changes in care, and patient-reported outcomes.
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startFeb 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Bruce Rapkin, Ph.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577811
- Sponsor's protocol ID
- 03-011
- Status last verified
- Jan 2009
- First submitted
- 18 Dec 2007
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enrollment, Dynamics of Care and Patient Outcomes in the NYS Medicaid HIV Special Needs Plans
- ClinicalTrials.gov ID
- NCT00577811
- Acronym / sponsor ID
- 03-011
- Conditions
- HIV Infections, Mental Health
- Keywords
- Special Need Plans, Fee for Services, Access to Care, Medicaid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 20 Dec 2007 (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 purpose of this study is to find out how people's needs are being met and what people do about problems with treatment, symptoms, substance use, mental health, and social services. We are also interested in finding out about changes that people make in their health care team and the reasons for making those changes.
Detailed description
This is a longitudinal study to examine access to care, perceived quality of life, member satisfaction and patient-reported outcomes among HIV+ adult Medicaid recipients. Special Needs Plans represent a new approach to managed care tailored to patients with complicated medical and psychosocial problems,requiring a high level of service. These plans combine HIV primary and specialty care, mental health services, substance use treatment, care for dependent children and social services into a single comprehensive program that also includes comprehensive case management and other provisions to retain patients in care. Special Needs Plans represent an alternative to both, Medicaid Fee for Service (FFS) and to mainstream Medicaid managed care.Seven different Special Needs Plans will be implemented, serving in New York City and the surrounding suburbs. A separate non-profit corporation administers each SpecialNeeds Plan. Each plan encompasses a network of hospitals, providers, and communitybased organizations. Although all plans offer many of the same basic services, they differ in terms of organization and coordination of care, approaches to case management,specific program enhancements (e.g., patient education, wellness programs, or complementary medicine) and special provisions to meet the needs of subgroups of patients (e.g., women, substance users, young gay men, Latinos). The HIV Special Needs Plans represent an innovation in health service delivery and financing that is being evaluated as a national model for Medicaid service delivery by the federal government, including HRSA and HCFA. This protocol represents a component of that evaluation,from the patients' perspective.This study is being conducted in collaboration with the New York State Department of Health (NYSDOH) AIDS Institute. As a component of their Quality Management and Improvement Programs, Special Need Plans have agreed to assist with recruitment of participants to this evaluation. We will recruit 120 patients sampled from each of the six plans and follow these patients for initially a year with a possibility of continuing to interview them for up to two years. We will also recruit a sample of 360 current Medicaid fee for service patients to serve as comparison group. This sampling strategy will allow us to examine experiences in care and outcomes for different subgroups of patients within the plans, distinguish the affects of service differences among the plans and compare different plan enrollees to similar patients who remain in the Medicaid FFS program. Our longitudinal design will also permit us to examine prospective influences on comparison group patients' decisions to switch their coverage from Medicaid FFS to Special Needs Plans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients from 6 different Special Need Plans |
| 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The NYSDOH AIDS Institute will obtain Case Report Forms from Special Need Plans. and if they have agreed to receive mail and/or telephone calls regarding the plan they have signed up for. All patients will be informed at the time they join a Special Needs Plan that they may be contacted by evaluators working with the NYSDOH AIDS Institute who willwant to ask them about enrollment and care in the plan. Patients who have not agreed to receive mail will only be contacted by telephone.At this time, a call will be made to conduct screening using the Enrollment module and ask the selected Special Needs Plan patient about their willingness toparticipate in the study.
Key inclusion criteria (7 listed)
- Medicaid Special Needs Plans or Fee For Service as health insurance at the timeof enrollment;
- Age 18 years or older
- A current resident of New York State
- Able to respond to interview questions in English or Spanish.
- Express willingness and ability to complete a series of one-hour long interviews (interviews may be completed over two telephone sessions, if PWHAs prefer)
Key exclusion criteria (1 listed)
- Enrollment onto the study at an earlier site (we may encounter the same PWHA at more than one FFS recruitment site) • Staff members from Special Needs Plans or FFS Recruitment site determine that it is inadvisable to refer a PWHA to this study for any reason.
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
This study makes use of several new assessment approaches designed to provide a more in depth understanding of access to care, changes in care, and patient-reported outcomes.
Time frame: 2010
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 15 Jan 2009.
- Memorial Sloan-Kettering Cancer websiteLink provided by the sponsor.
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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.
Bruce Rapkin, Ph.D. principal investigator
Memorial Sloan Kettering Cancer Center
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 HIV Infections and Mental Health, run by Memorial Sloan Kettering Cancer Center 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 7 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 15 Jan 2009. 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?
This study makes use of several new assessment approaches designed to provide a more in depth understanding of access to care, changes in care, and patient-reported outcomes. (time frame: 2010). 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 15 Jan 2009.