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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video | Experimental | An original brief 3 to 5 minute educational video, covering themes such as: defining OTC NSAIDs and their uses, potential harms of NSAIDs, and broad general alternatives. Will involve suggestion to speak to their healthcare provider. |
|
| Control | No Intervention | A static image of a standardized FDA warning label for OTC NSAIDs covering themes such as: uses of OTC NSAIDs, potential harms of NSAIDs, and suggestion to speak to their healthcare provider. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational video | Behavioral | Participants will view a brief 3-to-5-minute educational video (VIDEO), covering information that is already printed on FDA labels for OTC NSAIDs, on their own device covering themes such as: defining OTC NSAIDs, potential harms of NSAIDs, and alternatives. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Rockwell, PhD, RD | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Clinic Riverside 1 | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17325246 | Background | Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA; American Heart Association. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007 Mar 27;115(12):1634-42. doi: 10.1161/CIRCULATIONAHA.106.181424. Epub 2007 Feb 26. No abstract available. | |
| 27682515 |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006333 | Heart Failure |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
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 |
| Arfe A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G; Safety of Non-steroidal Anti-inflammatory Drugs (SOS) Project Consortium. Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. BMJ. 2016 Sep 28;354:i4857. doi: 10.1136/bmj.i4857. |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |