Clinical trial NCT06575205: Patient Education Video to Reduce OTC NSAIDs
Official title: A Brief Patient Educational Video to Reduce Potentially Harmful Over-the-counter Nonsteroidal Anti-inflammatory Drug (NSAID) Use
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Heart Failure
Hypertension
Keywords: Chronic Kidney Diseases
Heart Failure
Hypertension
Over the Counter NSAIDS
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: Virginia Polytechnic Institute and State University
First posted: 2024-08-28
Enrollment: 1452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to assess the efficacy of a brief 3 to 5-minute educational video on influencing intent to change behavior regarding potentially harmful over-the-counter (OTC) NSAID use in adults with chronic kidney disease (CKD), heart failure (HF), and/or hypertension (HTN). Informed by the COM-B model of behavior change, the video reviews identifying OTC NSAIDs, potential risks of NSAIDs, and general alternatives to potentially harmful NSAIDs. Participants with CKD, HF, and/or HTN identified as regular OTC NSAID users will be randomized to the VIDEO or CONTROL group. They will complete surveys immediately and 4 weeks after viewing the VIDEO or CONTROL to assess actual NSAIDs use, intent to change behavior related to NSAIDs use, capability/opportunity/motivation to change behavior, pain, and barriers to decreasing OTC NSAIDs. Findings will inform future population health initiatives to reduce potentially harmful OTC NSAIDs use.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Carilion Clinic patients
* Age \> = 18 years
* Diagnosis of CKD, HTN, and/or HF
* E-mail address or phone number on file.
* Able to speak and read English
* Able to respond to an online survey and view a video

Exclusion Criteria:

* Not Carilion Clinic patients
* Age \< 18
* No diagnosis of CKD, HTN, or HF
* No e-mail address or phone number on file
* Cannot speak or read English
* Not able to respond to an online survey or view a video

Primary outcomes:
measure: Contemplation Ladder score
timeFrame: baseline prior to viewing VIDEO or CONTROL and within 10 minutes after viewing VIDEO or CONTROL and 4 weeks later
measure: Self-reported OTC NSAID use
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Secondary outcomes:
measure: Barriers to decreasing OTC NSAIDs use
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
measure: Capability to decrease OTC NSAIDs use score
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
measure: Motivation to decrease OTC NSAIDs use score
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
measure: Rating of pain score
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
measure: Opportunity to decrease OTC NSAIDs use score
timeFrame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic Riverside 1
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Michelle Rockwell, PhD, RD
role: PRINCIPAL_INVESTIGATOR
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