NCT01449409

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

12.9 years

First QC Date

October 3, 2011

Last Update Submit

May 15, 2024

Conditions

Asthma

Keywords

Uncontrolled asthmaAsthma riskAsthma impairmentReal time asthma outreach program

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Frequency of patients with documented step-up care.

    1 year

  • Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy

    1 year

Study Arms (2)

Usual care

NO INTERVENTION

Real-time asthma care outreach

EXPERIMENTAL
Other: Real-time asthma care outreach

Interventions

Real-time asthma care outreachOTHER

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.

Also known as: Expedited asthma care management
Real-time asthma care outreach

Eligibility Criteria

Age12 Years - 56 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • KPSC members at time of uncontrolled event:
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Southern California Region

San Diego, California, 92111, United States

Location

Related Publications (2)

  • 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.

    PMID: 21348560BACKGROUND

  • 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.

    PMID: 21497885BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Robert S Zeiger, MD, PhD

    Kaiser Permanente Southern California Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Physician Investigator

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 10, 2011

Study Start

February 1, 2011

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations

US(1)