The research team will enroll 140 patients from the inpatient or outpatient setting from
the University of Chicago Medicine inpatient services, COPD/APN clinic, general medicine
clinic, and/or Pulmonary clinic until all participants have been enrolled (approximately
over the course of 12 months).
Patients will be randomized into one of two treatment conditions: one including use of
the inhaler training device and one with our standard brief intervention.
After obtaining informed consent, participants will complete assessments, including a
lung function test via spirometry, and inhaler education via either the Inhaler Trainer
Device learning program or standard education techniques. Participants randomized to the
inhaler training device arm will be trained on how to use their inhaler and the inhaler
trainer device. The Inhaler Trainer Device will monitor the patient's inspiratory
waveform to confirm technique compliance based on objective metrics and provide feedback
on how to better perform technique.
Participants will continue to use their inhaled medications with the inhaler trainer
device for 6 weeks post-baseline. They will return at 6 weeks post-initial instruction
for an in-person evaluation of their inhaler skills, lung function, and acute care
utilization. Finally, a post-study semi-structured interview will be conducted to gather
feedback on the device after the 6-week visit has been completed. This interview will
occur either during the 6-week follow-up visit or at a later time via phone call or zoom
call. In the interview, a standard elicitation framework guided by the Integrative Model
(IM) of Behavioral Prediction and Change will be used to generate feedback on training
experience. The research team will also prompt participants to give feedback on the
design, content, and functionality of the inhaler and training system. Additional prompts
and questions will be used to ensure that information is provided that speaks to
participants' perceptions of the positive and negative consequences related to using the
trainer.
The statistical team at the University of Chicago will conduct analyses including
descriptive summaries using means, medians, proportions, scatterplots, and histograms to
describe the data. McNemar's chi-squared tests will be used to compare 30-day follow-up
and inhaler misuse (≤10/12 steps correct) post-education vs. baseline. To model over
time, we will use generalized linear mixed method (GLMM) or generalized estimating
equations (GEE). A two-tailed p-value less than 0.05 will define statistical
significance. The sample size was powered on the primary outcome in Aim 1 for difference
in correct MDI use (>75% steps correct) between baseline and at 6 weeks.
