Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial

摘要 手术后麻醉镇痛处方导致阿片类药物非预期长期使用， 成千上万的美国人。这一趋势助长了阿片类药物的过度供应， 在全国范围内导致依赖、成瘾、转移和过量。非- 药物疼痛护理是有效的，并建议围手术期疼痛指南 同时提供更有利的风险收益比。然而，非药物性疼痛护理是 很少用作手术后的一线或二线治疗。患者和临床医生决策支持 干预措施在鼓励以患者为中心和与指南一致的护理方面是有效的，但 这些策略还没有在每天的术后疼痛中作为一个捆绑包进行实际测试 在乎NOHARM试验将首先确认面向患者以及临床医生的可行性， 面向EHR嵌入的循证包（目标1）的决策支持组件。 然后，我们将在4个健康中心的18个地点进行一项逐步楔形分组随机试验， 系统（目标2）附属于一个使用通用EHR的国家医疗保健组织 平台我们将测试一种可持续的系统战略， 围手术期疼痛管理向非药物选择的方式， 病人的功能，尊重病人的价值观，并保持阿片类药物作为最后手段的可用性。这 可以作为全国医疗机构的典范， 通过我们机构与最大的国家EHR供应商的持续合作。确保 我们的方法是可持续的，我们还将研究在所有研究地点什么有效，什么无效。 (Aim 3），重点关注母组织内的高风险患者，这些患者表达了高- 致力于解决阿片类药物危机。

ABSTRACT Prescriptions for narcotic pain relief after surgery result in unintended prolonged opioid use for hundreds of thousands of Americans. That trend fuels an excess supply of opioids that can lead to dependence, addiction, diversion, and overdoses on a national scale. Non- pharmacological pain care is effective and recommended by guidelines for perioperative pain while offering a more favorable risk benefit ratio. However, nonpharmacological pain care is rarely used as first or second-line therapy after surgery. Patient and clinician decision support interventions are effective in encouraging patient centered and guideline-concordant care, but these strategies have not been tested pragmatically as a bundle in every day postoperative pain care. The NOHARM trial will first confirmed the feasibility of patient-facing as well as clinician- facing decision support components of an EHR-imbedded evidence-based bundle (Aim 1). Then we will test our bundle in a step-wedge, cluster randomized trial at 18 sites in 4 Health Systems (Aim 2) affiliated with one national healthcare organization that uses a common EHR platform. We will test a sustainable system strategy that could change the paradigm of perioperative pain management toward nonpharmacological options in a manner that preserves patient function, honors patient values and maintains availability of opioids as a last resort. This could serve as a model for healthcare organizations nationally and could be disseminated through our institution’s ongoing partnership with the largest national EHR vendor. To ensure our approach is sustainable, we will also study what worked and what did not at all study sites (Aim 3), focusing on high-risk patients within a parent organization that has expressed a high- level commitment to addressing the opioid crisis.