Reduce IDentified UNcontrolled Asthma

NCT ID: NCT01449409

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Real-time asthma care outreach

Group Type: EXPERIMENTAL

Real-time asthma care outreach

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Expedited asthma care management

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Robert S. Zeiger, MD, PhD

Adjunct Physician Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert S Zeiger, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente Southern California Region

Locations

Kaiser Permanente Southern California Region

San Diego, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21348560 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21497885 (View on PubMed)

Related Links

http://www.kp-scalresearch.org/ClinicalTrials/ClinicalTrials.aspx

Kaiser Permanente Research and Evaluation Department Clinical Trials

http://xnet.kp.org/newscenter/aboutkp/research-ctrs.html

Kaiser Permanente Health Research

Other Identifiers

IRB # 5808

Identifier Type: -

Identifier Source: org_study_id