AsthmaNCT00355069
Better Pediatric Asthma Outcomes Through Chronic Care
A study testing electronic (computer based) provider feedback tool in people with Asthma, run by UConn Health at 1 site in United States.
Trial summary
This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children. The specific aims are to: 1. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- electronic (computer based) provider feedback tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 548 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to May 2003
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- determined by provider to be asthmatic
- member of Medical Managed Care Organization partner group
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030
About this study
This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children.
The specific aims are to:
Read more
- Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;
- Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and
- Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.
The key product of the computer support system is a guideline prompt that serves as the mechanism for integrating patient specific data with standards of care. 548 children, ages 5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in CT, and receiving care at one of four Federally Qualified Community Health Centers will be recruited. All sites will have access to the computer support system and the to-be-developed, Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of prompts delivered at the point of care on patient outcomes will be compared to the effect of no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education will be assessed in combination with prompted care compared to no-prompt care and compared to no education. All patients will receive standard screening and outreach to keep appointments. Data will be obtained from medical records, medical and pharmacy claims data as well as patient and parent interviews at baseline and quarterly for 18 months.
- Conditions
- Asthma
- Being tested
- electronic (computer based) provider feedback tool
- Keywords
- pediatric, asthma, translational research, health information technology
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic (computer based) provider feedback toolBehavioural
Also called UCAN Control Asthma Program, Medication Assessment Prompt (MAP)
All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education Receives: Behavioral: electronic (computer based) provider feedback tool |
| 2 | Experimental | Received the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education Receives: Behavioral: electronic (computer based) provider feedback tool |
| 3 | Experimental | Received the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt Receives: Behavioral: electronic (computer based) provider feedback tool |
| 4 | Placebo comparator | Received the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education) Receives: Behavioral: electronic (computer based) provider feedback tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma control
Measured: assessed at all 5 study visits
guideline appropriate medicating by providers
Measured: assessed at all 5 study visits
patient knowledge
Measured: assessed at all 5 study visits
Secondary outcomes (2)
self efficacy
Measured: assessed at all 5 study visits
social support
Measured: assessed at all 5 study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startAug 2001
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 548 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Judith Fifield, UConn Health
- Investigators
- Judith Fifield, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355069
- Sponsor's protocol ID
- 1U18HS011068-01
- Other IDs
- U18HS011068
- Status last verified
- May 2014
- First submitted
- 19 Jul 2006
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Twiggs JE, Fifield J, Jackson E, Cushman R, Apter A. Treating asthma by the guidelines: developing a medication management information system for use in primary care. Dis Manag. 2004 Fall;7(3):244-60. doi: 10.1089/dis.2004.7.244.
PubMed 15669584Twiggs JE, Fifield J, Apter AJ, Jackson EA, Cushman RA. Stratifying medical and pharmaceutical administrative claims as a method to identify pediatric asthma patients in a Medicaid managed care organization. J Clin Epidemiol. 2002 Sep;55(9):938-44. doi: 10.1016/s0895-4356(02)00428-6.
PubMed 12393083Fifield J, McQuillan J, Martin-Peele M, Nazarov V, Apter AJ, Babor T, Burleson J, Cushman R, Hepworth J, Jackson E, Reisine S, Sheehan J, Twiggs J. Improving pediatric asthma control among minority children participating in medicaid: providing practice redesign support to deliver a chronic care model. J Asthma. 2010 Sep;47(7):718-27. doi: 10.3109/02770903.2010.486846.
PubMed 20812783
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Pediatric Asthma Outcomes Through Chronic Care
- ClinicalTrials.gov ID
- NCT00355069
- Acronym / sponsor ID
- 1U18HS011068-01
- Conditions
- Asthma
- Keywords
- pediatric, asthma, translational research, health information technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 548 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2001
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 21 Jul 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.
This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children.
The specific aims are to:
- Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;
- Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and
- Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.
The key product of the computer support system is a guideline prompt that serves as the mechanism for integrating patient specific data with standards of care. 548 children, ages 5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in CT, and receiving care at one of four Federally Qualified Community Health Centers will be recruited. All sites will have access to the computer support system and the to-be-developed, Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of prompts delivered at the point of care on patient outcomes will be compared to the effect of no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education will be assessed in combination with prompted care compared to no-prompt care and compared to no education. All patients will receive standard screening and outreach to keep appointments. Data will be obtained from medical records, medical and pharmacy claims data as well as patient and parent interviews at baseline and quarterly for 18 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: electronic (computer based) provider feedback toolReceived the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt AND family education |
| 2 | Experimental | Behavioral: electronic (computer based) provider feedback toolReceived the Basic Pediatric Chronic Care Model AND the Medication Assessment Prompt but NOT family education |
| 3 | Experimental | Behavioral: electronic (computer based) provider feedback toolReceived the Basic Pediatric Chronic Care Model AND family education but NOT the Medication Assessment Prompt |
| 4 | Placebo comparator | Behavioral: electronic (computer based) provider feedback toolReceived the Basic Pediatric Chronic Care Model only (NO Medication Assessment Prompt and NO family education) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- determined by provider to be asthmatic
- member of Medical Managed Care Organization partner group
Key exclusion criteria (1 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 |
|---|---|---|
| electronic (computer based) provider feedback toolAlso: UCAN Control Asthma Program, Medication Assessment Prompt (MAP)All sites received a Basic Pediatric Chronic Care Model; 2x2 factorial design allocated the additional Medication Assessment Prompt and family education across the four sites as well. | Behavioural | 1, 2, 3, 4 |
Primary outcome
asthma control
Time frame: assessed at all 5 study visits
guideline appropriate medicating by providers
Time frame: assessed at all 5 study visits
patient knowledge
Time frame: assessed at all 5 study visits
2 secondary outcomes
self efficacy
Time frame: assessed at all 5 study visits
social support
Time frame: assessed at all 5 study visits
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 28 May 2014.
- Background: PubMed 15669584Twiggs JE, Fifield J, Jackson E, Cushman R, Apter A. Treating asthma by the guidelines: developing a medication management information system for use in primary care. Dis Manag. 2004 Fall;7(3):244-60. doi: 10.1089/dis.2004.7.244.
- Background: PubMed 12393083Twiggs JE, Fifield J, Apter AJ, Jackson EA, Cushman RA. Stratifying medical and pharmaceutical administrative claims as a method to identify pediatric asthma patients in a Medicaid managed care organization. J Clin Epidemiol. 2002 Sep;55(9):938-44. doi: 10.1016/s0895-4356(02)00428-6.
- Results publication: PubMed 20812783Fifield J, McQuillan J, Martin-Peele M, Nazarov V, Apter AJ, Babor T, Burleson J, Cushman R, Hepworth J, Jackson E, Reisine S, Sheehan J, Twiggs J. Improving pediatric asthma control among minority children participating in medicaid: providing practice redesign support to deliver a chronic care model. J Asthma. 2010 Sep;47(7):718-27. doi: 10.3109/02770903.2010.486846.
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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.
Judith Fifield, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic (computer based) provider feedback tool in people with Asthma, run by UConn Health 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 2 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 28 May 2014. 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. Some participants in this study may receive a placebo. 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?
asthma control (time frame: assessed at all 5 study visits). The study lists 3 primary outcomes in all. 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 NCT00355069, which also lists 3 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 28 May 2014.