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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | Both intervention and control arms will receive education. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N95 masks and indoor air cleaner | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| feasibility (by percent of enrolled patients who complete all follow-up assessments) | % of enrolled patients who complete all follow-up assessments | 30 days |
| fidelity | electrical sensors on the air cleaners showing the device was on for >80% of follow-up time | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| average screen-to-enrollment ratio | how many patients were contacted to enroll 1 patient | Through study completion, an average of 18 months |
| indoor and outdoor PM2.5 concentrations | air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Northern California Division of Research | Pleasanton | California | 94588 | United States |
organizational guidance
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randomized in-home intervention pilot trial
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data analysts
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| 30 days |
| respiratory quality of life | via St George's respiratory questionnaire for COPD - Part 1 : Symptoms component (frequency & severity) with a 1-month recall; Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall (dichotomous (true/false) except last question (4-point Likert scale)); Scores range from 0 to 100, with higher scores indicating more limitations | 30 days |
| effectiveness | FEV1 improvement by portable spirometry | 30 days |
| acceptability | >90% reporting satisfied/very satisfied on 5-point Likert scale as well as in qualitative interviews for feedback about the intervention, specifically which aspect of the intervention was most/least helpful and most/least burdensome, including aspects that should be changed to increase participation in future trials | 30 days |
| Urine oxidative stress | analysis of urinary F2-isoprostanes and Specific Gravity (SG) | 30 days |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000087162 | N95 Respirators |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D012134 | Respiratory Protective Devices |
| D000067393 | Personal Protective Equipment |
| D011482 | Protective Devices |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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