Reduce IDentified UNcontrolled Asthma

Not Applicable

Active, not recruiting

• Conditions: Asthma
• Interventions: Other: Real-time asthma care outreach

• Registration Number: NCT01449409
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study Start: 2011-02-01
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Primary Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 3000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time asthma care outreach	Real-time asthma care outreach	-

Primary Outcome Measures

Name	Time	Method
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.
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

Secondary Outcome Measures

Name	Time	Method
Frequency of patients with documented step-up care.	1 year
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy	1 year

Trial Locations

Locations (1)

Kaiser Permanente Southern California Region; 🇺🇸 San Diego, California, United States