Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in treating pain and
inflammation, but are also associated with multiple risks for some patients. Numerous
organizations recommend that older adults and patients with chronic diseases such as
kidney disease, heart failure, and hypertension avoid chronic use of NSAIDs. However,
high-risk use persists at undesirable rates. The goal of this study is to assess the
efficacy of an original, brief, 3 to 5 minute educational video, on influencing intent to
change behavior regarding potentially harmful over-the-counter (OTC) NSAID use. The study
population will involve adult patients from a large regional health system in the
southeastern U.S. with a diagnosis of chronic kidney disease (CKD), heart failure (HF),
and/or hypertension (HTN) as NSAID use is contraindicated in this population.
All patients with a diagnosis of CKD, HF, and/or HTN, who have an email address on file
will be invited to participate via email/REDCap. Upon clicking the link, general study
information will be provided for participant informed consent and a printable IRB subject
informational sheet will be made available to all potential participants and
participants. After acknowledgment by the participant, a pre-educational survey will
assess recent use of over-the-counter NSAIDs and general demographic information. Those
who meet criteria for regular NSAIDs use (>3 doses per week over previous 3 months) will
be immediately invited to participate in a randomized controlled trial (Education Tool
Survey accompanied by VIDEO or CONTROL).
Participants will answer 3 additional baseline pain level survey questions and 1
additional question regarding their baseline intent to change their current use of OTC
NSAIDs. Participants will then immediately be randomized to either view the brief 3 to 5
minute educational video (VIDEO) on their own device covering themes that are already
covered on the FDA warning label such as: defining OTC NSAIDs, potential harms of NSAIDs,
and alternatives or participants will view a standard OTC NSAIDs FDA warning label
(CONTROL). Trial participants will complete a survey electronically immediately after
viewing VIDEO or CONTROL covering questions about intent to change behaviors related to
OTC NSAID use and barriers, capability, opportunity, and motivation to change behaviors.
This portion of the study will take less than 10 minutes to complete.
Trial participants will complete a survey electronically again 4 weeks later regarding
questions about intent to change the use of OTC NSAIDs, actual use of OTC NSAIDs (for the
recent 4 week time period), levels of pain, and barriers, capability, opportunity, and
motivation to change behaviors. REDCap will auto-send the 4 week survey 4 weeks after
completion of the Education Tool Survey. This portion of the study will take less than 5
minutes to complete.
The study team will perform a multivariable linear regression to evaluate the association
of demographics on OTC NSAID use. The study team will use paired t-tests to evaluate
group and time differences. The study team will use stepwise forward multivariable linear
regression to evaluate the relative impact of secondary outcomes (barriers, capability,
opportunity, and motivation to change behaviors, and ratings of pain) on intent to change
NSAID use. Spearman's correlation analysis will also be performed between all variables.
Significance will be set at the 0.05 level.
Results of this study will inform population health interventions to reduce potentially
harmful OTC NSAIDs use.