Chronic Conditions Faced by Medicaid Recipients With DisabilitiesNCT00940511
Effects of Coordinated Care for Disabled Medicaid Recipients
A study testing Coordinated care in people with Chronic Conditions Faced by Medicaid Recipients With Disabilities, run by MDRC at 1 site in United States.
Trial summary
The purpose of this study is to improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. Although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Conditions Faced by Medicaid Recipients With Disabilities
- What is being tested?
- Coordinated care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,618 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Disabled, in fee-for-service Medicaid
Who cannot join
- Under age 18, over age 64
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. Although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the right doctors, helping them make and keep appointments, and helping them comply with medical or dietary recommendations. To understand the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and disabled Medicaid recipients in the Denver area.
- Being tested
- Coordinated care
- Keywords
- All conditions faced by disabled Medicaid recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Coordinated care | Experimental | Individuals will be passively enrolled in Medicaid managed care. Those who do not opt out of managed care will be provided with care coordination. Receives: Behavioral: Coordinated care |
| Usual care | No intervention | The usual care group will remain in fee-for-service Medicaid and receive services normally available through that system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health care use through Medicaid
Measured: Two years
Secondary outcomes (3)
Primary and preventive care
Measured: Six months, two years
Emergency department use
Measured: Six months, two years
Hospital admissions
Measured: Six months, two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Conditions Faced by Medicaid Recipients With DisabilitiesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDRC
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Care Strategies, Robert Wood Johnson Foundation, Colorado Department of Health Care Policy and Financing, Kaiser Permanente
- Responsible party
- Principal investigator, Charles Michalopoulos, MDRC
- Investigators
- Charles Michalopoulos, Ph.D., Principal investigator, MDRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940511
- Sponsor's protocol ID
- MDRC-CO-02
- Status last verified
- Mar 2016
- First submitted
- 14 Jul 2009
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Michalopoulos C, Manno MS, Warren A, Somers J. Managing Health Care for Medicaid Recipients with Disabilities: Final Report on the Kaiser Permanente Colorado Coordinated Care Pilot Program. New York: MDRC
Kim SE, Michalopoulos C, Kwong RM, Warren A, Manno MS. Telephone care management's effectiveness in coordinating care for Medicaid beneficiaries in managed care: a randomized controlled study. Health Serv Res. 2013 Oct;48(5):1730-49. doi: 10.1111/1475-6773.12060. Epub 2013 Apr 5.
PubMed 23557249
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coordinated Care for Disabled Medicaid Recipients
- ClinicalTrials.gov ID
- NCT00940511
- Acronym / sponsor ID
- MDRC-CO-02
- Keywords
- All conditions faced by disabled Medicaid recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,618 participants (actual)
- Lead sponsor
- MDRCUniversity, hospital or other
- Collaborators
- Center for Health Care Strategies, Robert Wood Johnson Foundation, Colorado Department of Health Care Policy and Financing, Kaiser Permanente
- Study start
- Aug 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Jul 2009 (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 improve the quality of care for individuals with multiple chronic conditions, health care systems have begun turning to coordinated care. Although coordinated care can refer to many different things, it usually includes activities such as assessing patients' needs, referring them to the right doctors, helping them make and keep appointments, and helping them comply with medical or dietary recommendations. To understand the effects of coordinated care for high-needs Medicaid recipients, MDRC is conducting a randomized trial of a pilot coordinated care program run by Kaiser Permanente for blind and disabled Medicaid recipients in the Denver area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated care | Experimental | Behavioral: Coordinated careIndividuals will be passively enrolled in Medicaid managed care. Those who do not opt out of managed care will be provided with care coordination. |
| Usual care | No intervention | –The usual care group will remain in fee-for-service Medicaid and receive services normally available through that system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Disabled, in fee-for-service Medicaid
Key exclusion criteria (1 listed)
- Under age 18, over age 64
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 |
|---|---|---|
| Coordinated care | Behavioural | Coordinated care |
Primary outcome
Health care use through Medicaid
Time frame: Two years
3 secondary outcomes
Primary and preventive care
Time frame: Six months, two years
Emergency department use
Time frame: Six months, two years
Hospital admissions
Time frame: Six months, two years
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 16 Mar 2016.
- Results publicationMichalopoulos C, Manno MS, Warren A, Somers J. Managing Health Care for Medicaid Recipients with Disabilities: Final Report on the Kaiser Permanente Colorado Coordinated Care Pilot Program. New York: MDRC
- Results publication: PubMed 23557249Kim SE, Michalopoulos C, Kwong RM, Warren A, Manno MS. Telephone care management's effectiveness in coordinating care for Medicaid beneficiaries in managed care: a randomized controlled study. Health Serv Res. 2013 Oct;48(5):1730-49. doi: 10.1111/1475-6773.12060. Epub 2013 Apr 5.
- Published reportsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Charles Michalopoulos, Ph.D. principal investigator
MDRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated care in people with Chronic Conditions Faced by Medicaid Recipients With Disabilities, run by MDRC 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 16 Mar 2016. 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?
Health care use through Medicaid (time frame: Two years). 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 NCT00940511, which also lists 2 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 16 Mar 2016.