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

项目摘要/摘要 慢性疼痛的认知行为疗法(CBT-CP)是一种基于证据的心理干预，即 能有效减轻慢性疼痛患者的疼痛，改善其功能。存在许多障碍以实现 面对面提供这种治疗，包括患者旅行的限制，需要经常面对面 会议，以及缺乏训练有素的治疗师。利用基于技术的干预措施，如交互式 语音应答(IVR)允许患者在家中进行治疗，这可能会改善获得 CBT-CP。这个项目的总体目标是进行一次务实的试验，以检验现实世界的有效性 一种基于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临床的干扰，并避免增加现场研究人员 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 从一个集中的退伍军人管理局地点交付COP。在为务实试验做准备时，初步研究阶段 (UG3)将：a)从60个妇女保健实践机构中确定参加试验的设施 网络(WH-PBRN)站点，b)检查EHR提供结果数据的充分性，c)确定 使用EHR提供商警报促进招聘的可行性，以及d)确保所有监管部门的批准以及 来自选定地点的领导层的支持。第二阶段(UH3)将比较退伍军人的结果 随机分为两组：1)COPS，为期10周的基于IVR的CBT和步行计划，外加任何提供商 处方药物和非药物疼痛治疗(COPES UC)，或2)面对面CBT-CP 由临床医生提供，之前通过VHA的循证心理治疗计划进行培训，以及任何 提供者开出的药理和非药理治疗(VHA、CBT-CP、UC)。病人将会是 比较疼痛强度和功能、EHR疼痛强度和医疗保健使用的综合测量 包括急诊科、紧急护理和特殊疼痛服务，以及药物和 非药物止痛干预。不同群体之间的吸收和结果差异也将是 评估可能存在治疗差异的地方(例如，性别、种族、精神健康并存)。 此外，将审查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综合 实施研究框架(CFIR)。CFIR指导下对研究现场临床医生和 管理人员将评估COPS和CBT-CP干预和实施方面的经验 调查结果将与参与网站和利益攸关方进行沟通。

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.