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.

项目概要/摘要 慢性疼痛认知行为疗法（CBT-CP）是一种基于证据的心理干预措施， 可有效减轻慢性疼痛患者的疼痛并改善其功能。存在许多障碍 面对面提供这种治疗，包括患者出行限制、需要经常亲自进行治疗 以及缺乏训练有素的治疗师。利用基于技术的干预措施，例如互动 语音应答 (IVR) 允许患者在家中接受治疗，可能会改善获得治疗的机会 CBT-CP。该项目的总体目标是进行务实的试验以检验现实世界的有效性 基于 IVR 的 CBT-CP 形式，称为合作疼痛教育和自我管理 (COPES)。在 本着务实试验的精神，我们的方法将最大限度地减少对诊所的干扰，并避免增加该领域的研究人员 通过使用 VHA 的电子健康记录 (EHR) 来促进招募和收集数据，同时 从 VA 集中地点提供 COPES。为做好务实试验的准备，初步研究阶段 (UG3) 将： a) 从 60 个基于妇女健康实践的机构中确定参与试验的机构 网络 (WH-PBRN) 站点，b) 检查 EHR 是否足以提供结果数据，c) 确定 使用 EHR 提供商警报来促进招聘的可行性，以及 d) 确保所有监管部门的批准 选定地点领导层的支持。第二阶段（UH3）将比较退伍军人的结果 随机选择：1) COPES，为期 10 周的基于 IVR 的 CBT 和步行计划以及任何提供者 处方药物和非药物疼痛治疗 (COPES+UC)，或 2) 现场 CBT-CP 由临床医生提供，之前接受过 VHA 循证心理治疗计划的培训以及任何 提供者规定药物和非药物治疗 (VHA CBT-CP+UC)。患者将会 比较疼痛强度和功能、EHR 疼痛强度和医疗保健使用的综合衡量标准 包括急诊科、紧急护理和专业疼痛服务以及药理学和 非药物疼痛干预措施。不同群体的接受程度和结果差异也将 在可能存在治疗差异的情况下进行评估（例如性别、种族、心理健康合并症）。 此外，还将审查 COPES 干预的成本，包括干预实施支出 和预算影响分析。最后，干预过程的评估将由综合 实施研究框架（CFIR）。 CFIR 引导下对研究中心临床医生的访谈 管理员将评估 COPES 和 CBT-CP 干预和实施的经验 研究结果将与参与地点和利益相关者进行沟通。