Cooperative Pain Education and Self-management: Expanding Treatment for Real-World

合作疼痛教育和自我管理：扩大现实世界的治疗范围

• 批准号: 10015199
• 负责人: Alicia Heapy
• 金额: $ 87.37万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10015199
• 关键词: Accident and Emergency department; Administrator; Alcohol consumption; Brief Pain Inventory; Caring; Clinic; Clinical; Cognitive Therapy; Data; Education; Effectiveness; Electronic Health Record; Emergency Care; Enrollment; Ethnic Origin; Evaluation; Evidence based intervention; Expenditure; Female; Future; Gender; Goals; Healthcare; Home environment; Improve Access; Institutional Review Boards; Intervention; Interview; Leadership; Location; Measures; Mental Health; Multi-Institutional Clinical Trial; Network-based; Outcome; Pain; Pain intensity; Pain management; Patients; Persons; Pharmacology; Phase; Preparation; Process; Provider; Psychotherapy; Race; Randomized; Research; Research Personnel; Secure; Self Management; Services; Site; Substance Use Disorder; Technology; Testing; Training; Travel; Treatment outcome; Variant; Veterans; Voice; Women' s Health; Work; base; budget impact; chronic pain; chronic pain patient; comorbidity; comparative effectiveness trial; cost; efficacy study; evidence base; experience; formative assessment; health administration; health practice; implementation research; improved functioning; male; medical specialties; pain reduction; patient-level barriers; point of care; pragmatic trial; primary endpoint; primary outcome; programs; psychologic; recruit; response; routine care; sex; treatment disparity; treatment group; trial comparing; trial design; uptake; urgent care; walking program

PROJECT SUMMARY/ABSTRACT Cognitive behavioral therapy for chronic pain (CBT-CP) is an evidence-based psychological intervention that is effective for reducing pain and improving function for patients with chronic pain. Numerous barriers exist to face-to-face delivery of this treatment, including patient travel limitations, the need for frequent in-person sessions, and the scarcity of trained therapists. Leveraging technology-based interventions, like interactive voice response (IVR), which allow patients to engage in treatment from their home, may improve access to CBT-CP. The overall goal of this project is to conduct a pragmatic trial to examine the real world effectiveness of an IVR-based form of CBT-CP called COoperative Pain Education and Self-management (COPES). In the spirit of pragmatic trials, our approach will minimize clinic disruption and avoid adding research staff in the field by using the VHA’s electronic health record (EHR) to facilitate recruitment and to collect data, all while delivering COPES from a centralized VA location. In preparation for the pragmatic trial, the initial study phase (UG3) will: a) identify facilities to participate in the trial from among the 60 Women’s Health Practice Based Network (WH-PBRN) sites, b) examine the adequacy of the EHR for providing outcome data, c) determine the feasibility of using EHR provider alerts to promote recruitment and d) secure all regulatory approvals along with support from leadership at selected sites. Phase two (UH3) will then compare outcomes among Veterans randomized to either: 1) COPES, a 10-week IVR-based CBT and walking program plus any provider prescribed pharmacological and non-pharmacological pain treatments (COPES+UC), or 2) in-person CBT-CP provided by clinicians, previously trained through VHA’s evidence based psychotherapy program plus any provider prescribed pharmacological and non-pharmacological treatments (VHA CBT-CP+UC). Patients will be compared on a composite measure of pain intensity and functioning, EHR pain intensity, and health care use including emergency department, urgent care, and specialty pain services along with pharmacological and non-pharmacological pain interventions. Uptake and variation in outcomes across groups will also be evaluated where treatment disparities are possible (e.g. by sex, race, mental health comorbidities). Additionally, the cost of the COPES intervention will be examined, including intervention delivery expenditures and budget impact analysis. Finally, evaluation of the intervention process will be informed by the Consolidated Framework for Implementation Research (CFIR). CFIR-guided interviews with study site clinicians and administrators will assess experiences with the COPES and CBT-CP interventions and implementation findings will be communicated with participating sites and stakeholders.

项目摘要/摘要 慢性疼痛（CBT-CP）的认知行为疗法是一种基于证据的心理干预措施 有效减轻慢性疼痛患者的疼痛和改善功能。存在许多障碍 该治疗的面对面交付，包括患者旅行限制，需要经常面对面 会议，以及训练有素的治疗师的稀缺性。利用基于技术的干预措施，例如交互式 语音反应（IVR）允许患者从家中进行治疗，可以改善获得的机会 CBT-CP。该项目的总体目标是进行务实的试验以检查现实世界的有效性 基于IVR的CBT-CP形式称为合作疼痛教育和自我管理（COPES）。在 务实试验的精神，我们的方法将最大程度地减少诊所的破坏并避免在现场增加研究人员 通过使用VHA的电子健康记录（EHR）来促进招聘并收集数据 从集中的VA地点交付应对。为了准备务实的试验，初始研究阶段 （UG3）将：a）确定从60位妇女健康实践中参与试验的设施 网络（WH-PBRN）站点，b）检查EHR提供结果数据的是否足够，c）确定 使用EHR提供商警报来促进招聘的可行性和D）确保所有监管部门的批准以及 选定站点领导的支持。然后，第二阶段（UH3）将比较退伍军人之间的结果 随机分配到：1）Copes，一个为10周IVR的CBT和步行计划以及任何提供商 处方药和非药物疼痛治疗（COPES+UC）或2）面对面的CBT-CP 由临床医生提供，以前接受过VHA的基于证据的心理治疗计划以及任何 提供者处方的药物和非药物治疗（VHA CBT-CP+UC）。患者会 比较疼痛强度和功能，EHR疼痛强度和医疗保健的综合测量 包括急诊科，紧急护理和专业疼痛服务以及药品和 非药物疼痛干预措施。跨组结果的吸收和差异也将是 评估治疗差异的位置（例如，通过性别，种族，心理健康合并症）。 此外，将检查COPES干预的费用，包括干预交付支出 和预算影响分析。最后，对干预过程的评估将由合并的 实施研究框架（CFIR）。 CFIR指导的研究网站临床医生和 管理员将评估COPES和CBT-CP干预措施的经验以及实施 调查结果将与参与的站点和利益相关者进行交流。