AsthmaNCT00137722
Outcomes From an Asthma Disease Management Program
An observational study of Asthma, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review data from a Medicaid Health Maintenance… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Education of providers and their staff, Case management and Payment for desired behaviors
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Aug 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Health plan members who have undergone disease management and who have a diagnosis of asthma (ICD9 code of 493.xx)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108
About this study
Official title: Identification of Outcomes From an Asthma Disease Management Program
Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review data from a Medicaid Health Maintenance Organization (HMO) to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients. The investigators wish to publish this so that other health plans can benefit from the investigators experience.
Read the detailed description
Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, we will review data from a Medicaid HMO to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients.
Data on subjects already exists in the Health Management database. We will use data that has been collected between January 1, 2000 and August 18, 2005. We will use a convenience sample consisting of available subjects meeting the program criteria. The total FHP database includes approximately 50,000 members from which approximately 6,000 have been identified as having asthma.
We will create a research database that will not contain any patient-specific data. Instead, an intermediate workstation will be programmed to query the health management database and send the resulting aggregated and de-identified data to the research database for analysis on another workstation. The research database will never contain any patient identifiers nor will it contain individual patient data. It only will contain aggregated data provided by the intermediate query workstation.
Here is a complete list of variables that will be housed in the research database for subsequent analysis:
Categorical variables: Asthma severity (intermittent, mild, moderate or severe persistent), Provider office, Quarter when seen, Medication type (controller or reliever), Age category (0-4, 5-9, 10-17, >17years), active status (active or inactive), Location (ER, Inpatient, Routine visit), Case managed (yes, no), Gender, Psychosocial issues, Diagnosis (asthma, not asthma)
Continuous variables: Cost of care, Number of visits, Number of prescriptions, Number of members in the above categories, Mean Quality of life
- Conditions
- Asthma
- Being tested
- Education of providers and their staff, Case management, Payment for desired behaviors
- Keywords
- Asthma, Disease Management, Outcomes, Utilization
- Medical subject headings
- Asthma, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education of providers and their staffBehavioural
Case managementBehavioural
Payment for desired behaviorsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJan 2000
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Jay M Portnoy, MD, Principal investigator, Children's Mercy Hospitals & Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137722
- Sponsor's protocol ID
- 05 08-110X
- Status last verified
- Dec 2008
- First submitted
- 29 Aug 2005
- Last updated
- 4 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Outcomes From an Asthma Disease Management Program
- ClinicalTrials.gov ID
- NCT00137722
- Acronym / sponsor ID
- 05 08-110X
- Conditions
- Asthma
- Keywords
- Asthma, Disease Management, Outcomes, Utilization
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jan 2000
- Study completion
- Aug 2005
- First posted
- 30 Aug 2005 (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.
Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, the investigators at Children's Mercy Hospitals and Clinics, will review data from a Medicaid Health Maintenance Organization (HMO) to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients. The investigators wish to publish this so that other health plans can benefit from the investigators experience.
Detailed description
Disease management is used to manage patients who have asthma and who are enrolled in a managed care health plan. To understand the effect of disease management on asthma severity and utilization, we will review data from a Medicaid HMO to determine the number of health plan members with different asthma severities and what their outcomes are. This will help us to improve the service provided to these patients.
Data on subjects already exists in the Health Management database. We will use data that has been collected between January 1, 2000 and August 18, 2005. We will use a convenience sample consisting of available subjects meeting the program criteria. The total FHP database includes approximately 50,000 members from which approximately 6,000 have been identified as having asthma.
We will create a research database that will not contain any patient-specific data. Instead, an intermediate workstation will be programmed to query the health management database and send the resulting aggregated and de-identified data to the research database for analysis on another workstation. The research database will never contain any patient identifiers nor will it contain individual patient data. It only will contain aggregated data provided by the intermediate query workstation.
Here is a complete list of variables that will be housed in the research database for subsequent analysis:
Categorical variables: Asthma severity (intermittent, mild, moderate or severe persistent), Provider office, Quarter when seen, Medication type (controller or reliever), Age category (0-4, 5-9, 10-17, >17years), active status (active or inactive), Location (ER, Inpatient, Routine visit), Case managed (yes, no), Gender, Psychosocial issues, Diagnosis (asthma, not asthma)
Continuous variables: Cost of care, Number of visits, Number of prescriptions, Number of members in the above categories, Mean Quality of life
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Health plan members who have undergone disease management and who have a diagnosis of asthma (ICD9 code of 493.xx)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education of providers and their staff | Behavioural | – |
| Case management | Behavioural | – |
| Payment for desired behaviors | Behavioural | – |
Primary outcome
Not reported in the source record.
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 4 Feb 2015.
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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.
Jay M Portnoy, MD principal investigator
Children's Mercy Hospitals & Clinics
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 Asthma, run by Children's Mercy Hospital Kansas City 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 0 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 4 Feb 2015. 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.
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 4 Feb 2015.