Clinical trial NCT01449409: Reduce IDentified UNcontrolled Asthma
Official title: Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Uncontrolled asthma
Asthma risk
Asthma impairment
Real time asthma outreach program
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2011-10-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

1. 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.

5. 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.

Eligibility criteria: Inclusion Criteria:

KPSC members at time of uncontrolled event:

1. 12-56 years of age
2. Continuously enrolled and with pharmacy benefit for the past year
3. Dispensed inhaled corticosteroid (ICS) in the past 6 months.
4. Uncontrolled asthma: defined within the past year

   * Impairment cohort: 7th short-acting beta-agonist (SABA) canister dispensed and/or
   * 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:

* Patients with chronic obstructive lung disease,
* emphysema,
* cystic fibrosis,
* chronic bronchitis,
* bronchiectasis,
* Churg Strauss,
* Wegener's,
* sarcoidosis,
* pulmonary hypertension or other clinically relevant non-asthma pulmonary disorder such as autoimmunity,
* immune deficiency,
* cancer,
* HIV,
* steroid dependent asthma,
* omalizumab therapy within the past 3 months, and
* requirement for an interpreter.

Primary outcomes:
measure: Oral corticosteroid courses for asthma exacerbations in risk cohort.
timeFrame: 1 year
measure: Short-acting beta-agonist dispensings.
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of patients with documented step-up care.
timeFrame: 1 year
measure: Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente Southern California Region
state: California
Study officials:
affiliation: Kaiser Permanente Southern California Region
name: Robert S Zeiger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.