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主要症状，存在于高达90%的复发性胰腺炎患者中。 急性胰腺炎（RAP）和慢性胰腺炎（CP）。随着疼痛的严重性和持续性的增加， 与显著的发病率相关，包括抑郁和焦虑症状，身体功能低下， 睡眠障碍和低生活质量，以及高经济和社会负担。痛苦的RAP和CP是 最常使用慢性阿片类药物治疗，不幸的是，这种药物的疗效有限， 不良副作用该应用程序的重点是解决疼痛管理中的这一治疗差距， 良好的非药物干预。我们的团队已经建立了一个互联网交付的效率 认知行为疗法（CBT）干预慢性疼痛，最近将其用于胰腺炎疼痛 (the胰腺炎疼痛课程），显示出减少这一人群的疼痛和残疾的希望。我们提出 混合有效性-实施设计类型1试验，以实现快速转化收益，主要目标是 收集关于CBT治疗对RAP患者胰腺炎疼痛和疼痛干预的影响的数据 和CP，次要目标是收集实施数据，以告知胰腺炎的传播 疼痛课程到现实世界的设置。我们的中心假设是胰腺炎疼痛课程将是有效的 减少疼痛性RAP和CP患者的疼痛干扰和严重程度。我们的具体目标是：（1） 确定胰腺炎疼痛疗程在改善胰腺炎疼痛结局方面的有效性，2） （探索性）探索健康的社会决定因素与疼痛干预变化的调节作用 和严重程度，以及3）确定实施促进者，挑战和解决方案， 结构和过程，有助于胰腺炎疼痛过程的无缝整合， 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）联盟，一个NIDDK赞助的U 01联盟，从他们的 九个临床中心，并通过与国家胰腺组织的合作，在社区中自我转诊 基金会采用多中心随机对照临床试验，我们将招募280名个体 将患有疼痛性CP的患者纳入临床试验，并将其随机分配至CBT， 学习疼痛自我管理技能的课程（例如，放松、活动步调、目标设定）或教育控制 （访问关于RAP和CP疼痛的教育网站）。我们将在基线时收集患者报告的结局， 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 管理人员）将参与过程评估，为诊所和社区的未来实施提供信息 设置.拟议的研究将显着推进CP非阿片类药物疼痛管理的解决方案。 如果成功的话，我们的项目将最大限度地减少护理方面的差距，并解决对低成本、可获得的 疼痛自我管理的个人与痛苦的CP。