Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- feasibility (by percent of enrolled patients who complete all follow-up assessments)
研究概览
简要总结
The overarching goal of this project is to conduct a pilot intervention in high-risk Kaiser Permanente Northern California patients with chronic obstructive pulmonary disease to mitigate their exposure to poor air quality and decrease exacerbations of lung disease.
详细描述
Over the past decade, the frequency and impact of wildfires has steadily worsened across California, a trend that is expected to continue as climate change becomes an urgent, everyday reality. This means that the number of Kaiser Permanente Northern California (KPNC) members exposed to unhealthy air quality due to wildfire smoke will increase dramatically. Unsurprisingly, vulnerable patients are disproportionately impacted, such as those with chronic obstructive pulmonary disease (COPD). In this rigorous pilot, we will deploy a pilot in-home intervention to non-smoking, oxygen-dependent patients who have frequent exacerbations of COPD to mitigate their exposure to poor air quality and reduce exacerbations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
data analysts
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •KPNC patients
- •enrolled in Care Plus
- •non-smoking
- •oxygen-dependent
- •adults aged ≥65 years old
- •have had membership for at least 1 year prior to data extraction not counting </=3mo gaps)
- •have known COPD (at least 2 encounters with COPD ICD codes over a 3 year period in the 10 years prior to data extraction using the following ICD codes: ICD-9 491.21, 491.22, 491.8, 491.9, 492.8, 493.2, 493.21, 493.22, 496 and ICD-10 J44.1, J44.0, J41.8, J44.9, J42)15
- •have picked up at least 1 controller inhaler at the pharmacy within 1 year prior to data extraction
- •at least 2 exacerbations of COPD treated in any setting (outpatient or acute care) within 1 year before to data extraction.
排除标准
- •with <1 year of continuous membership prior to the date they entered the cohort, allowing for 3-month, non-contiguous gaps
- •any diagnosis with any of the past or present problems: blindness, dementia, deaf or hearing impaired, hospice admission, "tracheostomy" procedure code or problems and/or attached to a ventilator
- •hearing, visually, physically, memory, and/or speech impaired
- •those on the "Do Not Call" list
- •non-English speakers.
研究组 & 干预措施
Intervention
Participants who are randomized into the intervention will receive N95 masks to be worn outdoors and an indoor air cleaner in the room that the participant spends the most time in their home. Both intervention and control arms will receive education.
干预措施: N95 masks and indoor air cleaner (Device)
Control
Both intervention and control arms will receive education.
结局指标
主要结局
feasibility (by percent of enrolled patients who complete all follow-up assessments)
时间窗: 30 days
% of enrolled patients who complete all follow-up assessments
fidelity
时间窗: 30 days
electrical sensors on the air cleaners showing the device was on for \>80% of follow-up time
次要结局
- acceptability(30 days)
- Urine oxidative stress(30 days)
- average screen-to-enrollment ratio(Through study completion, an average of 18 months)
- indoor and outdoor PM2.5 concentrations(30 days)
- respiratory quality of life(30 days)
- effectiveness(30 days)
- acceptability(30 days)
- Urine oxidative stress(30 days)
研究者
Laura Myers
Principal Investigator
Kaiser Permanente