RIDUNA: Reduce IDentified UNcontrolled Asthma
Study Details
Study Description
Brief Summary
The purpose of Reduce IDentified UNcontrolled Asthma (RIDUNA) is to determine the benefit of real-time identification of uncontrolled asthma by electronic administrative records linked to real-time notification of uncontrolled status to patients and asthma specialists with recommended guideline directed intervention by physicians. The investigators hypothesize that real-time outreach following National guideline asthma care recommendations, after real-time identification of an uncontrolled asthma event in persistent asthmatics on inhaled corticosteroids will lead to better improvements in asthma control (impairment and risk) compared to standard asthma care outreach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Co-primary Objectives: Determine the effectiveness of real-time identification administratively of uncontrolled asthma and real-time outreach administratively to optimize National asthma care guideline implementation compared to standard KP asthma outreach to improve asthma control (subsequent asthma impairment and risk, separately).
Hypothesis 1: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard Kaiser Permanente (KP) asthma outreach will reduce subsequent asthma impairment and risk, separately.
Hypothesis 2: Real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
Hypothesis 3: The real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will lead to increased step-up care that will reduce subsequent asthma impairment and risk.
Hypothesis 4: Specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) will be associated with a differential response in the intervention group.
Study Objectives:
- Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will reduce subsequent asthma impairment and risk, separately.
2: Determine whether real-time notification of uncontrolled asthma status to asthma specialists and patients compared to standard KP asthma outreach will increase the proportion of patients who receive step-up care for impairment and risk.
3: Determine whether the real-time notification of uncontrolled asthma status to asthma specialists and patients will lead to increased step-up care that will reduce subsequent asthma impairment and risk compared to standard KP asthma outreach.
4: Determine whether there exist specific demographic characteristics (older age, female gender, non-Hispanic white ethnicity, higher census block education/income level) that are associated with a greater differential efficacy in the intervention group.
- Determine in an exploratory analysis the frequency, characteristics (demographic, asthma severity, prior health care utilization, etc) and clinical outcomes (impairment and risk) of patients placed on omalizumab step-up therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Usual care
|
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| Experimental: Real-time asthma care outreach
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Other: Real-time asthma care outreach
Real-time asthma care identification of uncontrolled asthma and real-time notification of patients and their physicians of uncontrolled asthma and directions to improve care. Patients without an asthma specialist visit in the prior 3 years are offered an expedited allergy department referral.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Oral corticosteroid courses for asthma exacerbations in risk cohort. [1 year]
Measure in the follow-up year (1) frequency of patients requiring 2 or more oral corticosteroid courses in cohort with uncontrolled asthma based on risk
- Short-acting beta-agonist dispensings. [1 year]
Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.
Secondary Outcome Measures
- Frequency of patients with documented step-up care. [1 year]
- Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
KPSC members at time of uncontrolled event:
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12-56 years of age
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Continuously enrolled and with pharmacy benefit for the past year
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Dispensed inhaled corticosteroid (ICS) in the past 6 months.
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Uncontrolled asthma: defined within the past year
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Impairment cohort: 7th short-acting beta-agonist (SABA) canister dispensed and/or
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Risk (exacerbation) cohort: 2nd oral corticosteroid (OCS)dispensing with provider asthma exacerbation encounter within 2 days and at least 1 month after the first OCS dispensing.
Exclusion Criteria:
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Patients with chronic obstructive lung disease,
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emphysema,
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cystic fibrosis,
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chronic bronchitis,
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bronchiectasis,
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Churg Strauss,
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Wegener's,
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sarcoidosis,
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pulmonary hypertension or other clinically relevant non-asthma pulmonary disorder such as autoimmunity,
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immune deficiency,
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cancer,
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HIV,
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steroid dependent asthma,
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omalizumab therapy within the past 3 months, and
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requirement for an interpreter.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Southern California Region | San Diego | California | United States | 92111 |
Sponsors and Collaborators
- Kaiser Permanente
- Genentech, Inc.
Investigators
- Principal Investigator: Robert S Zeiger, MD, PhD, Kaiser Permanente Southern California Region
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Kaiser Permanente Research and Evaluation Department Clinical Trials
- Kaiser Permanente Health Research
Publications
- Schatz M, Zeiger RS. Improving asthma outcomes in large populations. J Allergy Clin Immunol. 2011 Aug;128(2):273-7. doi: 10.1016/j.jaci.2011.03.027. Epub 2011 Apr 17. Review.
- Zeiger RS, Schatz M, Li Q, Zhang F, Purdum AS, Chen W. Step-up care improves impairment in uncontrolled asthma: an administrative data study. Am J Manag Care. 2010;16(12):897-906.
- IRB # 5808