Chronic Obstructive Pulmonary Disease (COPD), Exacerbation of Chronic Obstructive Pulmonary Disease, Exacerbation of COPD
Conditions
Keywords
chronic obstructive pulmonary disease (COPD), air pollution, wildfire smoke
Brief summary
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.
Detailed description
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.
Interventions
DEVICEN95 masks and indoor air cleaner
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.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
data analysts
Intervention model description
randomized in-home intervention pilot trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| feasibility (by percent of enrolled patients who complete all follow-up assessments) | 30 days | % of enrolled patients who complete all follow-up assessments |
| fidelity | 30 days | electrical sensors on the air cleaners showing the device was on for \>80% of follow-up time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| average screen-to-enrollment ratio | Through study completion, an average of 18 months | how many patients were contacted to enroll 1 patient |
| indoor and outdoor PM2.5 concentrations | 30 days | air quality monitoring devices inside and outside the home, which record data internally when not connected to the internet |
| respiratory quality of life | 30 days | 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 |
| effectiveness | 30 days | FEV1 improvement by portable spirometry |
| acceptability | 30 days | \>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 |
| Urine oxidative stress | 30 days | analysis of urinary F2-isoprostanes and Specific Gravity (SG) |
Countries
United States
Outcome results
None listed