Internet-Delivered Pain Self-Management to Reduce Pain and Interference in Chronic Pancreatitis

互联网提供的疼痛自我管理可减少慢性胰腺炎的疼痛和干扰

• 批准号: 10753896
• 负责人: DARWIN LEWIS CONWELL
• 金额: $ 90.56万
• 依托单位: SEATTLE CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10753896
• 关键词: Abdominal Pain; Acute; Address; Anxiety; Behavioral; Chronic; Clinic; Clinical Cancer Center; Clinical Trials; Cognitive; Cognitive Therapy; Communities; Coupled; Data; Diabetes Mellitus; Disease; Dissemination and Implementation; Economics; Education; Enrollment; Evaluation; Evidence based intervention; Foundations; Gastrointestinal Diseases; Goals; Healthcare; Hospitalization; Hybrids; Individual; Internet; Intervention; Interview; Investigation; Learning; Malignant neoplasm of pancreas; Mental Depression; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Operative Surgical Procedures; Opioid; Pain; Pain Research; Pain interference; Pain management; Pancreas; Pancreatitis; Patient Outcomes Assessments; Patients; Phenotype; Physical Function; Population; Positioning Attribute; Practical Robust Implementation and Sustainability Model; Pragmatic clinical trial; Preparation; Process; Provider; Public Health; Quality of life; Randomized; Recurrence; Relaxation; Resources; Risk; Severities; Sleep disturbances; Structure; Symptoms; United States; United States National Institutes of Health; acute pancreatitis; anxiety symptoms; chronic pain; chronic pain management; chronic painful condition; chronic pancreatitis; clinical center; cohort; common symptom; community setting; cost; depressive symptoms; design; disability; economic cost; effectiveness evaluation; effectiveness testing; effectiveness/implementation design; evidence base; experience; follow-up; future implementation; health care disparity; health related quality of life; implementation facilitators; improved; mortality; non-opioid analgesic; opioid use; pain outcome; pain reduction; pain self-management; patient advocacy group; prescription opioid; primary outcome; process evaluation; programs; prospective; psychologic; randomized, clinical trials; recruit; secondary outcome; side effect; skills; sleep quality; social health determinants; societal costs; treatment effect; treatment response; web site

Project Summary Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, it is associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden. Painful RAP and CP is most often managed with chronic opioids, which unfortunately have limited efficacy and substantial risk for adverse side effects. This application focuses on addressing this treatment gap in pain management with a well-established nonpharmacologic intervention. Our team has established efficacy of an internet-delivered cognitive-behavioral therapy (CBT) intervention for chronic pain, and recently adapted it for pancreatitis pain (the Pancreatitis Pain Course), showing promise for reducing pain and disability in this population. We propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on CBT treatment effects on pancreatitis pain and pain interference in individuals with RAP and CP with a secondary goal of gathering implementation data to inform dissemination of the Pancreatitis Pain Course to real-world settings. Our central hypothesis is that the Pancreatitis Pain Course will be effective in reducing pain interference and severity in individuals with painful RAP and CP. Our specific aims are to 1) Determine the effectiveness of the Pancreatitis Pain Course in improving pancreatitis pain outcomes, 2) (Exploratory) Explore the moderating effects of social determinants of health with changes in pain interference and severity following treatment, and 3) Identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of the Pancreatitis Pain Course into clinical centers and the community. This study will leverage resources of the Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Consortium, a NIDDK-sponsored U01 consortium with recruitment from their nine clinical centers and from self-referral in the community through partnership with the National Pancreas Foundation. Using a multicenter randomized-controlled pragmatic clinical trial, we will enroll 280 individuals with painful CP into the clinical trial and randomize them to CBT, providing access to the Pancreatitis Pain Course to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or education control (access to education website about RAP and CP pain). We will collect patient-reported outcomes at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. The proposed investigation will significantly advance solutions for nonopioid pain management in CP. If successful, our project will minimize disparities in care, and address a critical need for low-cost, accessible pain self-management for individuals with painful CP.

项目摘要 严重的腹痛是胰腺炎的基本症状，多达90％的经常性患者出现 急性胰腺炎（RAP）和慢性胰腺炎（CP）。随着疼痛的严重程度和恒定性的增加，它是 与明显的发病率有关，包括抑郁症和焦虑症状，身体功能低， 睡眠障碍，生活质量较低，以及高经济和社会负担。痛苦的说唱和CP是 大多数经常使用慢性阿片类药物进行管理，不幸的是 不良副作用。本应用的重点是解决这种治疗差距，以 公认的非药物干预。我们的团队已经确立了互联网传递的功效 认知行为疗法（CBT）干预慢性疼痛，最近将其适应胰腺炎疼痛 （胰腺炎疼痛病程），显示出减少该人群疼痛和残疾的希望。我们建议 一个混合有效性 - 实现设计类型1试验，以实现主要目标的快速翻译增长 收集有关CBT治疗对RAP患者胰腺炎疼痛和疼痛干扰影响的数据 CP的次要目标是收集实施数据以告知胰腺炎的传播 现实环境的痛苦课程。我们的中心假设是胰腺炎疼痛病程将有效 在减少疼痛和CP患者的疼痛干扰和严重程度方面。我们的具体目的是1） 确定胰腺炎疼痛病程在改善胰腺炎疼痛结果方面的有效性，2） （探索性）探索健康的社会决定因素的调节作用，随着疼痛干扰的变化 以及治疗后的严重程度，以及3）确定实施促进者，挑战和解决方案 导致胰腺炎疼痛过程无缝整合到中的结构和过程 临床中心和社区。这项研究将利用慢性胰腺炎，糖尿病， 和胰腺癌（CPDPC）财团，一个由NIDDK赞助的U01联盟，并从其招募中招募 通过与国家胰腺合作，九个临床中心和社区中的自我推荐 基础。使用多中心随机控制的务实临床试验，我们将招募280个人 疼痛的CP进入临床试验，并将其随机与CBT，提供胰腺炎疼痛的访问权限 学习疼痛自我管理技能的课程（例如，放松，活动起搏，目标设定）或教育控制 （有关RAP和CP痛苦的教育网站）。我们将在基线时收集患者报告的结果 两个月和六个月的随访。相关利益相关者群体（患者，提供者，组织 经理）将参加流程评估，以告知未来在诊所和社区中的实施 设置。拟议的调查将大大提高CP中非阿片类药物疼痛管理的解决方案。 如果成功，我们的项目将最大程度地减少护理的差异，并满足对低成本，可访问的关键需求 CP疼痛的人的疼痛自我管理。