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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要剧烈腹痛是胰腺炎的主要症状，高达 90% 的复发性胰腺炎患者会出现剧烈腹痛急性胰腺炎（RAP）和慢性胰腺炎（CP）。随着疼痛的严重程度和持续时间的增加，与显着的发病率相关，包括抑郁和焦虑症状、身体机能低下、睡眠障碍、生活质量低下以及较高的经济和社会负担。痛苦的 RAP 和 CP 是最常使用慢性阿片类药物进行治疗，不幸的是，其疗效有限且存在巨大的风险不良副作用。该应用程序的重点是解决疼痛管理中的这一治疗差距完善的非药物干预。我们的团队已经建立了互联网交付的有效性认知行为疗法 (CBT) 干预慢性疼痛，最近又将其用于治疗胰腺炎疼痛（胰腺炎疼痛课程），显示出减轻该人群疼痛和残疾的希望。我们建议混合有效性实施设计类型 1 试验，以实现主要目标的快速转化收益收集 CBT 治疗对 RAP 患者胰腺炎疼痛和疼痛干扰的数据 CP 的次要目标是收集实施数据以告知胰腺炎的传播痛苦课程到现实世界的设置。我们的中心假设是胰腺炎疼痛疗程会有效减少 RAP 和 CP 患者的疼痛干扰和严重程度。我们的具体目标是 1) 确定胰腺炎疼痛课程在改善胰腺炎疼痛结果方面的有效性，2) （探索性）探索健康社会决定因素对疼痛干扰变化的调节作用和治疗后的严重程度，以及 3) 确定实施促进因素、挑战和解决方案有助于将胰腺炎疼痛课程无缝整合到临床中心和社区。这项研究将利用慢性胰腺炎、糖尿病、和胰腺癌 (CPDPC) 联盟，这是一个由 NIDDK 赞助的 U01 联盟，从他们的组织中招募成员九个临床中心以及通过与国家胰腺组织合作在社区进行自我转介基础。采用多中心随机对照实用临床试验，我们将招募 280 名个体将患有疼痛的 CP 纳入临床试验并将其随机分配至 CBT，从而提供了解胰腺炎疼痛的途径学习疼痛自我管理技能（例如放松、活动节奏、目标设定）或教育控制的课程（访问有关 RAP 和 CP 疼痛的教育网站）。我们将收集患者报告的基线结果，两个月，以及六个月的随访。相关利益相关者群体（患者、提供者、组织管理人员）将参与流程评估，为未来在诊所和社区的实施提供信息设置。拟议的研究将显着推进脑瘫非阿片类药物疼痛管理的解决方案。如果成功，我们的项目将最大限度地减少护理方面的差异，并满足低成本、可及性的迫切需求疼痛性脑瘫患者的疼痛自我管理。