JMIR Publications

ABSTRACT

Background:

Community advisors including patients, families, clinicians, and payers, are important partners who can guide clinical research; yet, there is little evidence documenting the impact of community engagement on study changes and outcomes.

Objective:

To describe the impact of community advisors on a pragmatic clinical trial.

Methods:

Using data from the PREPARE randomized pragmatic clinical trial studying the use of inhaled glucocorticoid (ICS) as part of rescue therapy for asthma, we examined the effect of protocol changes suggested by community advisors to address study implementation concerns.

Results:

Community advisors addressed two issues that threatened the success of overall research: low response rates to monthly outcomes surveys and low reported use of ICS with nebulizer rescue treatments. Initial low survey response rates were addressed by changing reminder frequency, shortening the survey, reducing the burden of logging in, and adding a raffle prize for timely responses. In the pilot phase of the study, the overall 3-month survey response rate was 66.7%. After protocol changes, the survey response rate over the first 3 months was 95.8% and was 87.4% for each individual’s final 3 months; the overall response rate for the full study was 92.3%. Early low use of ICS with nebulizers was addressed by additional communication, reminder stickers, and designing a method to attach a provided ICS inhaler to the nebulizers. For the full study 72% of participants completed all of their first three surveys compared with only 25% of pilot enrollees. The percent of people reporting use of 3 to 5 puffs of ICS with each nebulizer treatment rose from 42.1% (early full study) to 75.4% following protocol changes in which the participants received an extra ICS.

Conclusions:

Multi-component changes to the PREPARE protocol crafted by community advisors improved monthly survey rates and ICS adherence during nebulizer use. Clinical Trial: ClinicalTrials.gov number, NCT02995733