ISRCTN15819828进行中（未招募）未知
A 3-year cluster randomised controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.
Observational & Pragmatic Research Institute0 个研究点目标入组 1,512 人开始时间: 2021年10月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,512
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Criteria for participants (primary care practices):
- •1. Primary care (GP) practice in England
- •2. Has a minimum of 12 modifiable high-risk” COPD patients
- •Modifiable high-risk patients suitable for quality improvement programme:
- •Diagnosed COPD at baseline, i.e., already-diagnosed”:
- •1. Diagnosed with COPD at trial baseline
- •2. Aged 40 years or older at trial baseline
- •3. In baseline period: two or more moderate, or one or more severe, exacerbations in the 24 months preceding randomization, including at least one exacerbation in the last 12 months
- •4. Therapy at baseline: no therapy, on a short-acting bronchodilator (SABA, SAMA or SABA-SAMA), on monotherapy with a long-acting ß2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroid (ICS), or on dual therapy with LAMA-LABA or ICS-LABA
- •Undiagnosed patients with potential modifiable high-risk COPD:
- •1. No diagnosis of COPD at trial baseline
- •2. Aged 40 years or older by trial baseline
- •3. Current smoker, or ex-smoker with a significant smoking history (10+ years smoking duration or 10+ pack-years)
- •4. In baseline period: two or more moderate, or one or more severe exacerbations of potential COPD in the 24 months preceding randomization, including at least one exacerbation in the last 12 months
- •5. Therapy at baseline: no therapy, on a short-acting bronchodilator (SABA, SAMA or SABA-SAMA), on monotherapy with a long-acting ß2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroid (ICS), or on dual therapy with LAMA-LABA or ICS-LABA
排除标准
- •Criteria for participants (primary care practices):
- •1. Practices that are in the process of, or planning to change the electronic medical records system (also called GP clinical system) or practice ownership within the study period
- •2. Practices engaged in active research studies or COPD related Quality Improvement Programs which might impact the ability to implement the quality improvement programme (intervention)
- •Modifiable high-risk patients (diagnosed and undiagnosed COPD) not suitable for quality improvement programme:
- •1. Patients with a ‘consent refusal’ code in electronic medical records indicating opt-out for the usage of their data for research
- •2. Women who are pregnant at randomization or who become pregnant
- •3. Patients with a current asthma diagnosis and evidence of an asthma consultation in the last 24 months (applies to undiagnosed COPD only)
研究者
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