Patient Education Video to Reduce OTC NSAIDs
NCT Number: NCT06575205
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Kidney Diseases|Heart Failure|Hypertension
Interventions: BEHAVIORAL: Educational video
Sponsor: Carilion Clinic
Collaborators: Virginia Polytechnic Institute and State University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1452
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2023-08-02
Completion Date: 2025-03-15
Locations: Carilion Clinic Riverside 1, Roanoke, Virginia, 24016, United States

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.

Primary Outcome Measures: Contemplation Ladder score, Intent to change behavior related to OTC NSAID use, scored from 0 (no intent to decrease OTC NSAID use) to 10 (already committed to decreasing OTC NSAID use). A higher score is the better outcome (greater intent to decrease high-risk OTC NSAIDs)., baseline prior to viewing VIDEO or CONTROL and within 10 minutes after viewing VIDEO or CONTROL and 4 weeks later|Self-reported OTC NSAID use, NSAID use over the past 30 days, reported as number of days during the past 30 that OTC NSAIDs were used. The range of responses is 0 to 30., baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Secondary Outcome Measures: Barriers to decreasing OTC NSAIDs use, Participant response to open-ended survey question: What is the biggest barrier to decreasing your use of OTC NSAIDs?, baseline prior to viewing VIDEO or CONTROL and 4 weeks later|Capability to decrease OTC NSAIDs use score, 2 survey questions focused on capability portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived capability., baseline prior to viewing VIDEO or CONTROL and 4 weeks later|Motivation to decrease OTC NSAIDs use score, 2 survey questions focused on motivation portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived motivation., baseline prior to viewing VIDEO or CONTROL and 4 weeks later|Rating of pain score, Response to question: rate your pain over the past 30 days. This will be scored on a 6-point likert scale with 0=no pain and 5=severe pain., baseline prior to viewing VIDEO or CONTROL and 4 weeks later|Opportunity to decrease OTC NSAIDs use score, 2 survey questions focused on opportunity portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived opportunity., baseline prior to viewing VIDEO or CONTROL and 4 weeks later