Reduce IDentified UNcontrolled Asthma (RIDUNA)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Asthma
• Intervention / Treatment: Other: Real-time 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 Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92111
      • Kaiser Permanente Southern California Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 56 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Real-time asthma care outreach	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: Expedited asthma care management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Robert S Zeiger, MD, PhD, Kaiser Permanente Southern California Region

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Uncontrolled asthma; Asthma risk; Asthma impairment; Real time asthma outreach program
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: IRB # 5808