NeoplasmsNCT00385879
The Effects of Case Management in a Medicaid Managed Care Plan
A study testing Case management in people with Neoplasms and Heart Diseases, run by Metropolitan Jewish Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Heart Diseases, Adrenal Cortex Diseases
- What is being tested?
- Case management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jan 2008
- 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
- participation in a Medicaid managed care plan
- resident of identified zip codes in Brooklyn, NY
- frequent hospitalizations and low frequency of primary doctor visits
Who cannot join
- residents outside the catchment area
- patients not being managed in a Medicaid managed care plan
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Metropolitan Jewish Health System
Brooklyn, New York, 11220
Eliot Fishman, PhD
About this study
The purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan.
Read the detailed description
This study will assign participants based on Zip Code to one of two conditions: control and experimental. In the control group, participants will receive telephonic assessments at baseline, three months, and six months. These assessments will be conducted by a member of the Medical Center's Department of Geriatrics under the supervision of the Principal Investigator. Participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. Assessments will be conducted at baseline, three months, and six months during routine homecare visits. Dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. Data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. To measure participants' quality of life, the Depression Self-Rating Scale and the Clinical Anxiety Scale will be utilized. Data will be compared between and within the groups via statistical analyses. The researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.
- Conditions
- Neoplasms, Heart Diseases, Adrenal Cortex Diseases
- Being tested
- Case management
- Medical subject headings
- Neoplasms, Heart Diseases, Adrenal Cortex Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome measure for the number of emergency room visits will be calculated from the medical record counting the number of hospital emergency room visits; for access to primary physicians, the medical record will be reviewed as well.
Secondary outcomes (1)
The outcomes for quality of life will be evaluated from the McGill Quality of Life Questionnaire.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2006 (estimated)
- Study startMay 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Metropolitan Jewish Health System
- Sponsor type
- University, hospital or other
- Investigators
- Barbara Paris, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385879
- Sponsor's protocol ID
- Health Plus at Home
- Status last verified
- Oct 2006
- First submitted
- 9 Oct 2006
- Last updated
- 11 Oct 2006
- Results posted
- No
Publications
Chattopadhyay A, Bindman AB. The contribution of Medicaid managed care to the increasing undercount of Medicaid beneficiaries in the Current Population Survey. Med Care. 2006 Sep;44(9):822-6. doi: 10.1097/01.mlr.0000218835.78953.53.
PubMed 16932133
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Case Management in a Medicaid Managed Care Plan
- ClinicalTrials.gov ID
- NCT00385879
- Acronym / sponsor ID
- Health Plus at Home
- Conditions
- Neoplasms, Heart Diseases, Adrenal Cortex Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants
- Lead sponsor
- Metropolitan Jewish Health SystemUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Jan 2008
- First posted
- 11 Oct 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 purpose of this study is to evaluate whether or not case management by a social worker and nurse can decrease the number of emergency room visits, increase the number of primary care doctor visits, and increase quality of life of people in a Medicaid managed care plan.
Detailed description
This study will assign participants based on Zip Code to one of two conditions: control and experimental. In the control group, participants will receive telephonic assessments at baseline, three months, and six months. These assessments will be conducted by a member of the Medical Center's Department of Geriatrics under the supervision of the Principal Investigator. Participants in the experimental group will receive medical case management provided by a nurse and social worker in the homecare setting including an in-home assessment. Assessments will be conducted at baseline, three months, and six months during routine homecare visits. Dependent variables being measured include: access to primary care physicians, emergent hospitalizations/admissions, articulation of advance directives, and quality of life. Data will be collected through the participants' medical claims and records to analyze the number of emergent hospitalizations/admissions, documentation of advance directives, and number of visits to primary care physicians. To measure participants' quality of life, the Depression Self-Rating Scale and the Clinical Anxiety Scale will be utilized. Data will be compared between and within the groups via statistical analyses. The researcher will conduct pre-post comparisons of utilization and other database-derived outcomes for both groups, comparing the 12 months prior to and up to 20 months following enrollment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participation in a Medicaid managed care plan
- resident of identified zip codes in Brooklyn, NY
- frequent hospitalizations and low frequency of primary doctor visits
Key exclusion criteria (2 listed)
- residents outside the catchment area
- patients not being managed in a Medicaid managed care plan
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 |
|---|---|---|
| Case management | Behavioural | – |
Primary outcome
The outcome measure for the number of emergency room visits will be calculated from the medical record counting the number of hospital emergency room visits; for access to primary physicians, the medical record will be reviewed as well.
1 secondary outcome
The outcomes for quality of life will be evaluated from the McGill Quality of Life Questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2006.
- Results publication: PubMed 16932133Chattopadhyay A, Bindman AB. The contribution of Medicaid managed care to the increasing undercount of Medicaid beneficiaries in the Current Population Survey. Med Care. 2006 Sep;44(9):822-6. doi: 10.1097/01.mlr.0000218835.78953.53.
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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.
Barbara Paris, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case management in people with Neoplasms and Heart Diseases, run by Metropolitan Jewish Health System 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Oct 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Russell E Hilliard, PhD, LCSW (718-491-7214, rhilliar@mjhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The outcome measure for the number of emergency room visits will be calculated from the medical record counting the number of hospital emergency room visits; for access to primary physicians, the medical record will be reviewed as well.. 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 NCT00385879, which also lists 1 linked publication.
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 11 Oct 2006.