Abstract
Background: Prescription opioid abuse in the United States is a devastating public health crisis, of which many chronic opioid users were originally prescribed the medication for acute pain. Narrative enhanced risk communication may improve patient outcomes such as knowledge of opioid risk and opioid use behaviors in the setting of acute pain.
Methods & Design: Patients presenting to the acute care facilities of four geographically and ethnically diverse United States hospital centers with renal colic or musculoskeletal back pain will be eligible for this multicenter randomized clinical trial. A control group of patients receiving a standardized, general risk information sheet will be compared to two intervention groups, one receiving the risk information sheet plus a probabilistic opioid risk tool and another receiving the risk information sheet plus a 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 treatment preferences for fewer opioids; 2) reduced use of opioids as measured by quantity of opioids taken, functional improvement, and repeat use of unscheduled visits for pain; 3) patient-provider alignment as measured by concordance between patient preference and finalized prescription plan and the presence of shared decision making. To assess these outcomes, we will administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the ninety days after discharge.
Discussion: 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.
Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial
