PHLT 8046 Week 11 Full Grant Proposal Example Example

Clean Bedrooms During Smoke Season: A Full Resubmitted Application for a Randomized, Sham-Controlled Trial of Portable HEPA Filtration and Children's Urgent Asthma Care in an Inland County

Student Name

Walden University

PHLT 8046: Grant Writing and Review for Public Health Research

Instructor Name

Month Day, Year

Clean Bedrooms During Smoke Season: A Full Resubmitted Application for a Randomized, Sham-Controlled Trial of Portable HEPA Filtration and Children's Urgent Asthma Care in an Inland County

Project Summary

Smoke from distant wildfires now settles over inland communities for days at a time, and children with asthma suffer more exacerbations when it does. Families are told to keep a clean room with a portable air cleaner, yet whether that advice prevents urgent asthma care has never been tested in a trial. This resubmitted application proposes a two-season randomized trial in which 300 young people with persistent asthma, between their sixth and eighteenth birthdays and all enrolled through Medicaid plans and community health centers, receive either a working HEPA cleaner or an identical unit without its filter. The trial will measure bedroom particle levels, count urgent asthma visits from records and track how often families run the units on smoke days. Results will tell health departments and payers whether distributing cleaners is a sound use of smoke preparedness funds.

Specific Aims

The long-term goal is evidence on which public agencies can base cleaner distribution for young asthma patients. Aim 1 will measure how far a bedroom HEPA cleaner lowers indoor fine particles on smoke days relative to outdoor levels, testing the prediction of at least a 40% lower indoor-to-outdoor ratio than in sham homes. Aim 2 will test whether working cleaners cut the rate of emergency, urgent care and unscheduled asthma visits across two fire seasons by at least 30%, with the largest difference expected during smoke periods. Aim 3 will identify what keeps families from running cleaners on smoke days and estimate the payer's cost per urgent visit prevented. Each prediction states the result that would count against it.

Research Strategy

Significance

Wildfire smoke reliably worsens asthma, as a critical review of the health literature concluded (Reid et al., 2016), and smoke from the 2007 San Diego fires was followed by more emergency care for respiratory illness among Medicaid enrollees (Hutchinson et al., 2018). Portable HEPA units can remove most fine particles from a room during smoke, though how well they perform in real homes varies with leakiness and use (Barn et al., 2008; Xiang et al., 2021). The one trial linking cleaners to fewer unscheduled asthma visits involved secondhand tobacco smoke, a steady daily exposure unlike episodic wildfire smoke (Lanphear et al., 2011). Agencies are already distributing cleaners and payers are weighing coverage; both are acting on an untested step between cleaner air and fewer emergencies. A positive result would justify those programs and show how to target them. A result showing lower particles but no fewer visits would redirect preparedness toward other measures.

Innovation

The trial is the first to randomize home filtration against a sham during wildfire smoke with a health care outcome taken from records. It pairs continuous indoor and outdoor sensing in every home with runtime metering, so that exposure reduction, actual use and health outcome are measured in the same children. It also builds community guidance into design and delivery, as the funding announcement requires.

Approach

The study runs in an inland county where regional smoke has lasted ten days or more in each of the past five seasons. Eligible children, whose asthma is persistent and who needed urgent care in the prior year, are identified from plan and health center records, invited by mail and enrolled at home by bilingual community health workers. Randomization is stratified by age band and housing type. Units come from a mid-priced commercial model with no ionizer, rated below 40 decibels on its night setting, a change made after a 12-home pilot in which noise was the leading reason for switching units off. Sham units keep their pre-filter and look and sound the same.

A smoke day requires both a satellite smoke plume over the county and a daily fine particle average above 35.4 micrograms per cubic meter at the regulatory monitor, a pairing that distinguishes fire smoke from other pollution (Henderson et al., 2011); a secondary definition uses a lower 12.0 threshold. For Aim 1, corrected low-cost sensors indoors and outdoors yield daily ratios analyzed with mixed models. For Aim 2, negative binomial regression compares visit rates by intention to treat; local claims from 2022 to 2024 show 1.7 urgent visits per eligible child across two fire seasons, so that 150 children per arm give 80% power to detect a 30% lower rate, and a neighboring-county cohort can be activated if early rates fall short. For Aim 3, metered runtime and baseline concerns enter mixed logistic models, and costs follow established methods for valuing filtration (Fisk & Chan, 2017). A short text on smoke days records where each child spent the day, and families guess their assignment at the end to test masking.

Changes Since the Previous Submission

In response to the panel, the application now rests its power calculation on local claims rather than a general estimate, makes smoke-day use a prespecified secondary outcome supported by pilot data, adds a lower-threshold sensitivity definition of smoke days and a measure of where children spend smoke days, and states plainly that the trial tests a bedroom intervention rather than total exposure reduction.

Protection of Human Subjects

The trial involves minimal risk and enrolls children under the federal provisions that permit such research with parental permission and child assent. Permission is sought in English or Spanish at home; children 7 and older give assent. Records, addresses and survey responses are stored separately under study numbers, and a Certificate of Confidentiality covers the data. A three-member monitoring board meets twice a year. Every sham-arm family receives a working cleaner from a county foundation when follow-up ends.

Community Engagement Plan

An advisory board of eight members, including parents of children with asthma, a school nurse, a promotora and representatives of a tenant organization, meets quarterly with paid stipends. The board reviewed recruitment materials in the pilot, chose the text wording for smoke alerts and will help interpret results and decide how findings return to families before publication.

Data Management and Sharing Plan

De-identified sensor, runtime, survey and outcome data, with a data dictionary and analysis code, will be deposited in a public repository within a year of the primary publication, following the federal data management and sharing policy (National Institutes of Health [NIH], 2020). Claims data cannot be shared under plan agreements, but derived, de-identified analysis files will be. Sensor data will be shared at daily resolution without addresses.

Timeline and Budget Overview

Year 1 covers agreements, hiring, advisory board formation and recruitment. The second and third years span the two smoke seasons, and the final two years cover claims follow-up, analysis, dissemination with the advisory board and transfer of cleaners to sham-arm families. The detailed budget, justified line by line, concentrates supply costs in years 2 and 3 and analysis costs in years 4 and 5.

References

Barn, P., Larson, T., Noullett, M., Kennedy, S., Copes, R., & Brauer, M. (2008). Infiltration of forest fire and residential wood smoke: An evaluation of air cleaner effectiveness. Journal of Exposure Science & Environmental Epidemiology, 18(5), 503-511. https://doi.org/10.1038/sj.jes.7500640

Fisk, W. J., & Chan, W. R. (2017). Effectiveness and cost of reducing particle-related mortality with particle filtration. Indoor Air, 27(5), 909-920. https://doi.org/10.1111/ina.12371

Henderson, S. B., Brauer, M., MacNab, Y. C., & Kennedy, S. M. (2011). Three measures of forest fire smoke exposure and their associations with respiratory and cardiovascular health outcomes in a population-based cohort. Environmental Health Perspectives, 119(9), 1266-1271. https://doi.org/10.1289/ehp.1002288

Hutchinson, J. A., Vargo, J., Milet, M., French, N. H. F., Billmire, M., Johnson, J., & Hoshiko, S. (2018). The San Diego 2007 wildfires and Medi-Cal emergency department presentations, inpatient hospitalizations, and outpatient visits: An observational study of smoke exposure periods and a bidirectional case-crossover analysis. PLoS Medicine, 15(7), Article e1002601. https://doi.org/10.1371/journal.pmed.1002601

Lanphear, B. P., Hornung, R. W., Khoury, J., Yolton, K., Lierl, M., & Kalkbrenner, A. (2011). Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics, 127(1), 93-101. https://doi.org/10.1542/peds.2009-2312

National Institutes of Health. (2020). Final NIH policy for data management and sharing (Notice No. NOT-OD-21-013).

Reid, C. E., Brauer, M., Johnston, F. H., Jerrett, M., Balmes, J. R., & Elliott, C. T. (2016). Critical review of health impacts of wildfire smoke exposure. Environmental Health Perspectives, 124(9), 1334-1343. https://doi.org/10.1289/ehp.1409277

Xiang, J., Huang, C.-H., Shirai, J., Liu, Y., Carmona, N., Zuidema, C., Austin, E., Gould, T., Larson, T., & Seto, E. (2021). Field measurements of PM2.5 infiltration factor and portable air cleaner effectiveness during wildfire episodes in US residences. Science of the Total Environment, 773, Article 145642. https://doi.org/10.1016/j.scitotenv.2021.145642