Leave Me Out! Patients’ Characteristics and Reasons for Opting Out of a Pragmatic Clinical Trial

Join us as this presenter discusses this poster live on May 25, 2021 | Track A at 1:00 PM Mountain

PRESENTER
LISA CAPUTO SANDY
University of Colorado Anschutz Medical Campus
BACKGROUND
Pragmatic clinical trials (PCT) aim to inform healthcare decisions and treatment effectiveness based on data from real-world settings and populations. This generally requires that data be collected from a large and representative population, which in turn necessitates minimizing costs and burdens for patients and clinicians that can be associated with traditional clinical research, such as elaborate written informed consent processes. Opt out consent practices are sometimes used as a means to promote patients’ autonomous preferences regarding research participation while reducing both patient and researcher burden. Despite this, little is known about the characteristics of patients who choose to opt-out of research and their reasons for doing so. Therefore, we gathered such information in a large PCT seeking to improve medication adherence via evidence-based text messages employing nudge theory.
SETTING/POPULATION
This trial included patients from the VA Eastern Colorado Health Care System and Denver Health and Hospital Authority aged 18 – 89 years of age diagnosed with least one cardiovascular condition and prescribed at least one medication to treat the condition(s). Patients that did not speak English or Spanish, did not have a cell phone or home address on file, or did not reside within the State of Colorado were excluded.
METHODS
Eligible patients identified through Electronic Health Records were sent informational material about the study and were provided an opportunity to opt out. Those who opted out were asked to complete a voluntary survey regarding their reasons for choosing not to participate. Demographic data and reasons for opting out were compared with patients enrolling in the study using chi-squared tests.
RESULTS
Of 9,444 patients eligible for the trial, 895 (9.5%) patients opted out. Of those who opted out, 451 (50.1%) returned the opt out survey. Patients who opted out were more likely to be older, male, white, and non-Hispanic than those that did not (p<0.001 for all). Nearly half (46.6%) of respondents reported concerns about time as a reason to opt out of the study. Perceptions of not needing the intervention (19.5%) and discomfort with technology (18.6%) were the next most common responses. Conclusions: In this PCT focused on medication adherence improvement, less than 10% of patients opted out of participation, with significant differences in age, race, gender, and ethnicity between patients that opted out and those that did not. Future trials may wish to provide additional information to address the most commonly cited reasons by patients for opting out of a low-risk trial. The impact additional patient characteristics may have on opting out will be analyzed in April and May.
POSTER

Loader Loading...
EAD Logo Taking too long?

Reload Reload document
| Open Open in new tab

Posted in 2021 Poster Session, Community and Stakeholder Engagement.