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Reduce IDentified UNcontrolled Asthma (RIDUNA)

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Real-time asthma care outreach
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Uncontrolled asthma, Asthma risk, Asthma impairment, Real time asthma outreach program

Eligibility Criteria

12 Years - 56 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente Southern California Region

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Real-time asthma care outreach

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Frequency of patients with documented step-up care.
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy

Full Information

First Posted
October 3, 2011
Last Updated
April 8, 2022
Sponsor
Kaiser Permanente
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01449409
Brief Title
Reduce IDentified UNcontrolled Asthma
Acronym
RIDUNA
Official Title
Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2011 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Uncontrolled asthma, Asthma risk, Asthma impairment, Real time asthma outreach program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Title
Real-time asthma care outreach
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Real-time asthma care outreach
Other Intervention Name(s)
Expedited asthma care management
Intervention Description
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 Outcome Measure Information:
Title
Oral corticosteroid courses for asthma exacerbations in risk cohort.
Description
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
Time Frame
1 year
Title
Short-acting beta-agonist dispensings.
Description
Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Frequency of patients with documented step-up care.
Time Frame
1 year
Title
Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: KPSC members at time of uncontrolled event: 12-56 years of age Continuously enrolled and with pharmacy benefit for the past year Dispensed inhaled corticosteroid (ICS) in the past 6 months. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Zeiger, MD, PhD
Organizational Affiliation
Kaiser Permanente Southern California Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California Region
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21348560
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.
Results Reference
background
PubMed Identifier
21497885
Citation
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.
Results Reference
background
Links:
URL
http://www.kp-scalresearch.org/ClinicalTrials/ClinicalTrials.aspx
Description
Kaiser Permanente Research and Evaluation Department Clinical Trials
URL
http://xnet.kp.org/newscenter/aboutkp/research-ctrs.html
Description
Kaiser Permanente Health Research

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Reduce IDentified UNcontrolled Asthma

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