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

术后医院康复疼痛管理 (NOHARM) 实用临床试验中的非药物选择

基本信息

批准号：
10210513
负责人：
Andrea Lynne Cheville
金额：
$ 152.13万
依托单位：
MAYO CLINIC ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-30 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10210513
关键词：
Address Adoption American Amputation Bundling Caring Cesarean section Chronic Clinical Cluster randomized trial Colorectal Surgery Complex Conduction Anesthesia Consumption Data Collection Data Element Dependence Discipline Disease Education Ensure Evaluation Exercise Goals Guidelines Gynecologic Surgical Procedures Health system Healthcare Systems Hospitals Institution Intervention Joints Lead Lower Extremity Methods Modality Modeling Monitor Narcotics Operative Surgical Procedures Opioid Outcome Overdose Pain Pain management Parents Patient Preferences Patients Perioperative Perioperative Care Policies Population Postoperative Pain Postoperative Period Pragmatic clinical trial Procedures Public Health Quality of life Replacement Arthroplasty Reporting Research Resort Risk Role Site Specific qualifier value Symptoms System Testing Touch sensation Vendor Work addiction base body-mind care delivery chronic pain clinical decision support cohort design disability discrete data disparity reduction effective intervention evidence base health care model health care service organization high risk implementation research implementation strategy improved multimodality non-opioid analgesic novel opioid epidemic opioid misuse opioid use opioid user pain reduction pain rehabilitation pain relief patient oriented preference prescription opioid preservation risk benefit ratio safe patient satisfaction support tools surgery outcome trend uptake

项目摘要

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.

抽象的手术后用于缓解麻醉性疼痛的处方会导致意外地长期使用阿片类药物这种趋势加剧了阿片类药物的供应过剩。导致全国范围内的依赖、成瘾、转移和过量。药物疼痛护理是有效的，并被围手术期疼痛指南推荐同时提供更有利的风险收益比然而，非药物疼痛护理是。很少用作手术后的一线或二线治疗。干预措施可以有效鼓励以患者为中心和符合指南的护理，但是这些策略尚未在日常术后疼痛中进行实际测试 NOHARM 试验将首先确认面向患者和临床医生的可行性。面对嵌入 EHR 的循证捆绑包的决策支持组件（目标 1）。然后，我们将在 4 个健康中心的 18 个地点进行阶梯楔形、整群随机试验来测试我们的捆绑包隶属于一个使用通用 EHR 的国家医疗保健组织的系统（目标 2）我们将测试一个可以改变范式的可持续系统策略。围手术期疼痛管理转向非药物选择，以保留患者功能，尊重患者价值观并维持阿片类药物的可用性作为最后的手段。可以作为全国医疗保健组织的典范并可以传播通过我们机构与最大的国家电子病历供应商的持续合作，以确保。我们的方法是可持续的，我们还将研究所有研究地点的哪些方法有效，哪些无效（目标 3），重点关注母组织内表达了高风险的患者解决阿片类药物危机的高度承诺。