Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 20, 2020
Date Accepted: Jul 21, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Using Stories to Communicate Individual Risk for Opioid Prescriptions: Study Protocol for the Life STORRIED Multicenter Randomized Clinical Trial
ABSTRACT
Background:
Prescription opioid misuse in the United States is a devastating public health crisis, of which many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative enhanced risk communication may improve patient outcomes such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain.
Objective:
We will study the effect of probabilistic and narrative enhanced opioid risk communication on: 1) knowledge as measured by risk awareness and recall at 14 days post-enrollment 2) reduced preference for or use of opioids after the emergency department episode.
Methods:
This is a multi-site randomized controlled trial (RCT). Patients presenting to the acute care facilities of four geographically and ethnically diverse United States hospital centers with acute renal colic or musculoskeletal back and/or neck pain are eligible for this RCT. A control group of patients receiving a standardized, general risk information is compared to two intervention groups, one receiving the risk information sheet plus an individualized, visual probabilistic opioid risk tool and another receiving the risk information sheet plus a video narrative enhanced probabilistic opioid risk tool. We will study the effect of probabilistic and narrative enhanced opioid risk communication on: 1) knowledge as measured by risk awareness and recall at 14 days post-enrollment 2) reduced preference for or use of opioids after the emergency department episode. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the ninety days after discharge.
Results:
1302 patients were enrolled over 24 months. Mean age was 40, 53% female, 43% white, 38% black, 75% back pain, and 25% were at medium or high risk. Demographics and ORT scores were equally distributed across arms.
Conclusions:
This study seeks to assess the potential clinical role of narrative enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, stakeholder involvement, and dissemination considerations. Clinical Trial: Registry name: ClinicalTrials.gov Registration number: NCT03134092 Date of registration: 3/21/2017
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