Overview

This trial is active, not recruiting.

Condition asthma
Treatment real-time asthma care outreach
Phase phase 4
Sponsor Kaiser Permanente
Collaborator Genentech, Inc.
Start date February 2011
End date December 2015
Trial size 3000 participants
Trial identifier NCT01449409, IRB # 5808

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(No Intervention)
(Experimental)
real-time asthma care outreach Expedited asthma care management
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.

Primary Outcomes

Measure
Oral corticosteroid courses for asthma exacerbations in risk cohort.
time frame: 1 year
Short-acting beta-agonist dispensings.
time frame: 1 year

Secondary Outcomes

Measure
Frequency of patients with documented step-up care.
time frame: 1 year
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy
time frame: 1 year

Eligibility Criteria

Male or female participants from 12 years up to 56 years old.

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.

Additional Information

Official title Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
Principal investigator Robert S Zeiger, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Kaiser Permanente.