Reduce IDentified UNcontrolled Asthma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - 56 |
| Updated: | 4/17/2018 |
| Start Date: | February 1, 2011 |
| End Date: | December 31, 2018 |
Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
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.
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.
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.
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.
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.
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