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: 10225516
• 负责人: Alicia Heapy
• 金额: $ 93.73万
• 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/10225516
• 关键词: Accident and Emergency department; Administrator; Alcohol consumption; Brief Pain Inventory; Caring; Clinic; Clinical; Cognitive Therapy; Consolidated Framework for Implementation Research; Data; Education; Effectiveness; Electronic Health Record; Emergency Care; Enrollment; Ethnic Origin; Evaluation; Evidence based intervention; Expenditure; Female; Future; Gender; Goals; Healthcare; Home; 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; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Research; Research Personnel; Secure; Self Management; Services; Site; Substance Use Disorder; Technology; Testing; Training; Travel; Treatment outcome; Variant; Veterans; Veterans Health Administration; 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 practice; improved functioning; male; medical specialties; pain reduction; patient-level barriers; point of care; pragmatic trial; primary endpoint; primary outcome; programs; provider factors; psychologic; recruit; remote therapy; 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 慢性疼痛的认知行为疗法（CBT-CP）是一种循证心理干预， 对慢性疼痛患者有止痛和改善功能的作用。存在许多障碍， 面对面提供这种治疗，包括患者旅行限制，需要经常亲自 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，如互动 语音应答（IVR）允许患者在家中进行治疗， CBT-CP。本项目的总体目标是进行一次务实的试验，以检验真实的世界的有效性 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临床的干扰，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）来促进招聘和收集数据，同时 从一个集中的VA位置交付COPES。为准备实用性试验，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加试验的机构 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提供者警报来促进招聘的可行性，以及d）确保所有监管批准沿着 在选定地点得到领导的支持。第二阶段（UH 3）将比较退伍军人之间的结果 随机分配至：1）COPES，一项为期10周的基于IVR的CBT和步行计划加上任何提供者 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，以前通过VHA的循证心理治疗计划培训，加上任何 提供者处方的药物和非药物治疗（VHA CBT-CP+UC）。患者将 比较疼痛强度和功能，EHR疼痛强度和医疗保健使用的综合指标 包括急诊科，紧急护理和专业疼痛服务沿着药理学和 非药物性疼痛干预。各组之间结果的吸收和变化也将 在可能存在治疗差异的情况下进行评价（例如，按性别、种族、精神健康合并症）。 此外，还将审查COPES干预措施的成本，包括干预措施的实施支出 预算影响分析。最后，干预进程的评价将由联合国 实施研究框架（CFIR）。CFIR指导的研究中心临床医生访谈， 管理人员将评估COPES和CBT-CP干预和实施的经验 调查结果将与参与研究中心和利益相关者进行沟通。