Laying the Foundation for Building a Resilient KPNC Community in the Face of Worsening Air Quality Due to Wildfire Smoke

N/AEnrolling By InvitationNCT07118189

Kaiser Permanente20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)Exacerbation of COPD Exacerbation of Chronic Obstructive Pulmonary Disease

Interventions

N95 masks and indoor air cleanerDEVICE

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaiser Permanente Northern California Division of Research

Pleasanton, California, United States

Outcomes

Primary Outcomes

feasibility (by percent of enrolled patients who complete all follow-up assessments)

% of enrolled patients who complete all follow-up assessments

Time frame: 30 days

fidelity

electrical sensors on the air cleaners showing the device was on for \>80% of follow-up time

Time frame: 30 days

Secondary Outcomes

average screen-to-enrollment ratio

how many patients were contacted to enroll 1 patient

Time frame: 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

Time frame: 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

Time frame: 30 days

effectiveness

FEV1 improvement by portable spirometry

Time frame: 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

Data from ClinicalTrials.gov

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