- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00385879
The Effects of Case Management in a Medicaid Managed Care Plan
October 10, 2006 updated by: Metropolitan Jewish Health System
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Russell E Hilliard, PhD, LCSW
- Phone Number: 718-491-7214
- Email: rhilliar@mjhs.org
Study Contact Backup
- Name: Eliot Fishman, PhD
- Phone Number: 718-491-7134
- Email: efishman@mjhs.org
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11220
- Recruiting
- Metropolitan Jewish Health System
-
Sub-Investigator:
- Eliot Fishman, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- participation in a Medicaid managed care plan
- resident of identified zip codes in Brooklyn, NY
- frequent hospitalizations and low frequency of primary doctor visits
Exclusion Criteria:
- residents outside the catchment area
- patients not being managed in a Medicaid managed care plan
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
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.
|
Secondary Outcome Measures
Outcome Measure |
---|
The outcomes for quality of life will be evaluated from the McGill Quality of Life Questionnaire.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barbara Paris, MD, Maimonides Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion
December 7, 2022
Study Completion
January 1, 2008
Study Registration Dates
First Submitted
October 9, 2006
First Submitted That Met QC Criteria
October 10, 2006
First Posted (Estimate)
October 11, 2006
Study Record Updates
Last Update Posted (Estimate)
October 11, 2006
Last Update Submitted That Met QC Criteria
October 10, 2006
Last Verified
October 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Health Plus at Home
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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