Redmond Sarah, Tilburt Jon, Cheville Andrea
Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic Rochester, 200 1st St SW, Rochester, MN, 55905, USA.
Division of General Internal Medicine, Mayo Clinic Scottsdale, 13400 East Shea Blvd., Scottsdale, AZ, 85259, USA.
Pain Ther. 2022 Sep;11(3):1037-1053. doi: 10.1007/s40122-022-00393-x. Epub 2022 Jun 3.
Opioids may be necessary for guideline-concordant acute perioperative pain management, but their use carries risks for unintended prolonged use and addiction. Guidelines recommend use of validated non-pharmacological pain care (NPPC) approaches in conjunction with prescribed opioids and other analgesics. Our protocol outlines a population-level, pragmatic trial that will test a bundled intervention comprised of an electronic health record (EHR) portal-based conversation guide, EHR clinical decision support (CDS), and a suite of self-management educational and support materials to encourage and advance NPPC use.
We are conducting a stepped-wedge, cluster-randomized pragmatic trial spanning seven surgical specialties across six geographically diverse locations within the Mayo Clinic Enterprise. Thirty two surgical practices across six locations (Rochester, Minnesota; Mankato, Minnesota; La Crosse, Wisconsin; Eau Claire, Wisconsin; Phoenix, Arizona; Jacksonville, Florida) comprise 22 distinct practice clusters that are randomly assigned to one of five steps using constrained randomization. Steps "go live" by initiating the intervention at 7-month intervals between March 2021 and July 2023. Patients over 18 years of age who are scheduled for qualifying procedures within "live" consenting practices are sent a Healing After Surgery guide via their patient portals pre-operatively, directing them to identify their preferred NPPC modalities among 13 approaches. These selections create CDS options for care teams to support patients with self-management materials that reinforce safe NPPC use.
Patients' clinical, demographic, and outcome data will be abstracted from the Epic EHR. Primary outcomes will be the Patient Reported Outcomes Measurement Information System (PROMIS) pain interference and physical functioning computer adaptive tests (CAT) collected at 1, 2, and 3 months postoperatively via the patient portal. We will mail printed versions of the 6-item PROMIS short forms to portal non-responders to minimize bias. Secondary outcomes will include the PROMIS anxiety CAT, opioid consumption, and self-reported NPPC use.
ClinicalTrials.gov identifier, NCT04570371.
阿片类药物可能是符合指南的围手术期急性疼痛管理所必需的，但使用它们存在意外长期使用和成瘾的风险。指南建议将经过验证的非药物疼痛护理（NPPC）方法与处方阿片类药物及其他镇痛药联合使用。我们的方案概述了一项针对人群的实用试验，该试验将测试一种综合干预措施，该措施包括基于电子健康记录（EHR）门户的对话指南、EHR临床决策支持（CDS）以及一套自我管理教育和支持材料，以鼓励和促进NPPC的使用。
我们正在进行一项阶梯式楔形整群随机实用试验，涉及梅奥诊所企业内六个地理位置不同的七个外科专科。六个地点（明尼苏达州罗切斯特；明尼苏达州曼卡托；威斯康星州拉克罗斯；威斯康星州欧克莱尔；亚利桑那州凤凰城；佛罗里达州杰克逊维尔）的32个外科科室组成22个不同的科室集群，使用受限随机化方法将其随机分配到五个步骤之一。各步骤在2021年3月至2023年7月期间每隔7个月启动干预措施“上线”。18岁以上且计划在“上线”的同意参与试验的科室进行符合条件手术的患者，术前会通过其患者门户收到一份《术后康复指南》，指导他们在13种方法中确定自己偏爱的NPPC方式。这些选择为护理团队创建了CDS选项，以便通过强化安全NPPC使用的自我管理材料来支持患者。
患者的临床、人口统计学和结果数据将从Epic EHR中提取。主要结果将是通过患者门户在术后1、2和3个月收集的患者报告结果测量信息系统（PROMIS）疼痛干扰和身体功能计算机自适应测试（CAT）。我们将把6项PROMIS简表的印刷版邮寄给未回复门户的患者，以尽量减少偏差。次要结果将包括PROMIS焦虑CAT、阿片类药物消耗以及自我报告的NPPC使用情况。
ClinicalTrials.gov标识符，NCT04570371。
