Reduce IDentified UNcontrolled Asthma

Asthma Clinical Trial

— RIDUNA  

Official title:

Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01449409
• Other study ID #: IRB # 5808
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2011
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 56 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Southern California Region	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral corticosteroid courses for asthma exacerbations in risk cohort.	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	1 year
Primary	Short-acting beta-agonist dispensings.	Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.	1 year
Secondary	Frequency of patients with documented step-up care.		1 year
Secondary	Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy		1 year

External Links

•   Kaiser Permanente Health Research
•   Kaiser Permanente Research and Evaluation Department Clinical Trials