Reduce IDentified UNcontrolled Asthma: A Real-time Randomized Administrative Outreach Study to Promote Asthma Guideline Implementation (RIDUNA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Short-acting beta-agonist dispensings.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 56 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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,
- •steroid dependent asthma,
- •omalizumab therapy within the past 3 months, and
- •requirement for an interpreter.
研究组 & 干预措施
Usual care
Real-time asthma care outreach
干预措施: Real-time asthma care outreach (Other)
结局指标
主要结局
Short-acting beta-agonist dispensings.
时间窗: 1 year
Frequency of patients requiring 7 or more short-acting beta-agonist dispensings in cohort with uncontrolled asthma based on impairment.
Oral corticosteroid courses for asthma exacerbations in risk cohort.
时间窗: 1 year
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
次要结局
- Frequency of patients with documented step-up care.(1 year)
- Frequency, characteristics, and exacerbations of patients placed on omalizumab therapy(1 year)
研究者
Robert S. Zeiger, MD, PhD
Adjunct Physician Investigator
Kaiser Permanente