Meisel Zachary F, Goldberg Erica B, Dolan Abby R, Bansal Esha, Rhodes Karin V, Hess Erik P, Cannuscio Carolyn C, Schapira Marilyn M, Perrone Jeanmarie, Rodgers Melissa A, Zyla Michael M, Bell Jeffrey J, McCollum Sharon, Shofer Frances S
Center for Emergency Care Policy and Research, Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
Department of Population Health Management, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, United States.
JMIR Res Protoc. 2020 Sep 24;9(9):e19496. doi: 10.2196/19496.
Prescription opioid misuse in the United States is a devastating public health crisis; 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.
Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain.
This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative-enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge.
A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms.
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, and stakeholder involvement as well as dissemination considerations.
ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19496.
美国处方阿片类药物滥用是一场毁灭性的公共卫生危机；许多慢性阿片类药物使用者最初是因急性疼痛而被开具此类药物。视频叙事增强的风险沟通可能会改善患者的治疗效果，比如对阿片类药物风险的认知以及急性疼痛发作后的阿片类药物使用行为。
我们的目的是评估概率性和叙事增强的阿片类药物风险沟通对因背痛和肾结石疼痛前往急诊科就诊患者报告的结局的影响，这些结局包括知识、阿片类药物使用情况以及患者偏好。
这是一项多中心随机对照试验。在美国四个地理位置和种族多样的医院中心的急性护理机构就诊且患有急性肾绞痛疼痛或肌肉骨骼性背痛和/或颈痛的患者有资格参加此随机对照试验。将接受一般风险信息的对照组患者与两个干预组进行比较：一组接受风险信息表加个性化的视觉概率性阿片类药物风险工具（ORT），另一组接受风险信息表加视频叙事增强的概率性ORT。我们将研究概率性和叙事增强的阿片类药物风险沟通对以下方面的影响：入组后14天的风险意识和回忆、急诊科就诊后阿片类药物使用减少或偏好、以及与患者偏好和医生处方的一致性。为评估这些结局，我们在急性护理入院期间进行基线患者调查，并在出院后3个月内的预定时间进行随访调查。
在24个月内共招募了1302名患者。参与者的平均年龄为40岁（标准差14），1302名中有692名（53.15%）为女性，1302名中有556名（42.70%）为白人，1302名中有498名（38.25%）为黑人，1302名中有1002名（76.96%）有背痛，1302名中有334名（25.65%）处于中度或高风险。人口统计学和ORT评分在各分组中均匀分布。
本研究旨在评估叙事增强的、基于风险的沟通在急性护理环境中急性疼痛管理中的潜在临床作用。本文概述了用于实施该研究的方案，并强调了关键的方法学、统计学以及利益相关者的参与情况以及传播方面的考虑因素。
ClinicalTrials.gov NCT03134092；https://clinicaltrials.gov/ct2/show/NCT03134092。
国际注册报告标识符（IRRID）：DERR1-10.2196/19496。
