Reduce IDentified UNcontrolled Asthma (RIDUNA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Robert S. Zeiger, MD, PhD, Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01449409
First received: October 3, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Other: Real-time asthma care outreach
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Oral corticosteroid courses for asthma exacerbations in risk cohort. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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

  • Short-acting beta-agonist dispensings. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.


Secondary Outcome Measures:
  • Frequency of patients with documented step-up care. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Expedited asthma care management

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.

  Eligibility

Ages Eligible for Study:   12 Years to 56 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449409

Locations
United States, California
Kaiser Permanente Southern California Region
San Diego, California, United States, 92111
Sponsors and Collaborators
Kaiser Permanente
Genentech
Investigators
Principal Investigator: Robert S Zeiger, MD, PhD Kaiser Permanente Southern California Region
  More Information

Additional Information:
Publications:
Responsible Party: Robert S. Zeiger, MD, PhD, Adjunct Physician Investigator, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01449409     History of Changes
Other Study ID Numbers: IRB # 5808
Study First Received: October 3, 2011
Last Updated: April 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Uncontrolled asthma
Asthma risk
Asthma impairment
Real time asthma outreach program

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014