Tele-Collaborative Outreach to Rural Patients with Chronic Pain: The CORPs Trial

对患有慢性疼痛的农村患者进行远程协作外展：CORPs 试验

基本信息

批准号：
10591347
负责人：
Travis Ian Lovejoy
金额：
$ 73.06万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-14 至 2023-09-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10591347
关键词：
Activities of Daily Living Address Adult Affect Birth Care given by nurses Caring Case Manager Chronic Clinical Clinical Trials Cold Therapy Collaborations Communication Communities Community Health Services Community Health Systems Complementary Health Consultations Cost Effectiveness Analysis Data Data Collection Development Education Effectiveness of Interventions Ethnic Origin Exercise Therapy Feeling suicidal Female Foundations Future General Population Geography Goals Health Insurance Health Services Accessibility Health care facility Health system Heterogeneity Integrative Medicine Intensive Care Intervention Lead Letters Medicare/Medicaid Mental Health Methods Mindfulness Training Modality Modeling Not Hispanic or Latino Opioid Outcome Pain Pain Clinics Pain Measurement Pain intensity Pain interference Pain management Pain quality Participant Patient Education Patients Persistent pain Pharmacology Phase Physical Function Physical therapy Physicians Population Privatization Procedures Protocols documentation Provider Quality of life Race Randomized Randomized Clinical Trials Relaxation Therapy Reporting Research Resources Rural Rural Health Safety Self Management Severities Site Sleep Social support Symptoms System Term Birth Testing Therapeutic heat application United States Department of Veterans Affairs Veterans Veterans Health Administration Woman Work base biopsychosocial care coordination care systems chronic pain chronic pain management chronic pain patient clinical research site clinically significant collaborative care collaboratory compare effectiveness design effective intervention effectiveness testing evidence base experience follow-up future implementation implementation evaluation implementation intervention implementation process improved incremental cost-effectiveness male medical specialties operation outreach pain model pain self-management payment pilot test pragmatic trial prescription monitoring program primary outcome process evaluation programs recruit rural area rural patients secondary outcome sex substance use suicidal behavior telehealth treatment as usual treatment effect treatment services

项目摘要

Project Summary The overall goal of this multisite, pragmatic, randomized clinical trial is to adapt and test a tele-collaborative care intervention for chronic pain with veterans living in rural areas. During the 1-year UG3 phase, we will apply evidence-based quality improvement strategies to adapt our tele-collaborative pain care intervention for implementation across four geographically diverse VA health care facilities; pilot test and refine recruitment, intervention and data collection protocols at study sites; and, in collaboration with the Pain Management Collaboratory Coordinating Center, develop standard operating procedures for all activities to be conducted in the UH3 clinical trial phase. Engagement panels will inform adaptation of the intervention and all components of the methods of the clinical trial. During the 4-year UH3 phase, we will implement and evaluate the intervention among rural veterans with high impact chronic pain in a 12-month pragmatic effectiveness trial. We plan to recruit 152 veterans from each of four clinical sites (total N=608), diverse in terms of birth sex, race, and ethnicity. Participants will be randomized to receive either tele-collaborative pain care or minimally enhanced usual care. The intervention is based on the collaborative care model and includes an initial biopsychosocial chronic pain assessment with a nurse care manager, follow-up, and participation in a pain education group. The nurse care manager will receive consultation from a pain physician and participants may be referred for nonpharmacologic and complementary and integrative health treatments for chronic pain. The nurse care manager will also follow up with rural veterans and help them navigate care across VA and community health services. We hypothesize that rural veterans who receive tele-collaborative pain care, relative to minimally enhanced usual care, will evidence decreased pain severity and interference, increased physical functioning and quality of life, decreased mental health symptom severity and suicidal ideation and behavior, improved sleep, and increased utilization of nonpharmacologic and complementary and integrative health pain treatments. We further hypothesize that treatment effects will persist across female vs. male rural veterans and those who identify as white non-Hispanic vs. minoritized race or ethnicity. Finally, we will conduct an implementation process evaluation and an incremental cost-effectiveness analysis to inform development of an implementation toolkit. Study results will inform the future rollout of tele-collaborative pain care for rural veterans nationally.

项目摘要这个多站点的务实，随机临床试验的总体目标是适应和测试远程授权的与居住在农村地区的退伍军人的慢性疼痛的护理干预。在1年的UG3阶段，我们将采用基于证据的质量改进策略来调整我们的远程授权疼痛护理干预措施在四个地理上不同的VA医疗机构中实施；试点测试和完善招聘，研究地点的干预和数据收集方案；并且，与疼痛管理合作协作协调中心，为所有活动制定标准操作程序 UH3临床试验阶段。参与面板将告知改编干预措施和所有组件临床试验的方法。在4年UH3阶段，我们将实施并评估在一项为期12个月的务实有效性试验中，具有高影响慢性疼痛的农村退伍军人之间的干预。我们计划从四个临床部位（总n = 608）中的每一个招募152名退伍军人，在出生性，种族，种族，种族方面有所不同和种族。参与者将被随机接收远程促进疼痛或最少增强了通常的护理。干预措施基于协作护理模型，包括一个初始与护士护理经理，随访和参与疼痛的生物心理社会慢性疼痛评估教育小组。护士护理经理将获得疼痛医生的咨询，参与者可能会被转诊为非药物和互补和综合健康治疗方法，以缓解慢性疼痛。这护士护理经理还将与农村退伍军人进行跟进，并帮助他们在弗吉尼亚州进行护理以及社区卫生服务。我们假设接受远程监护疼痛护理的农村退伍军人，相对于最小增强的常规护理，将证据减轻疼痛严重程度和干扰，增加身体功能和生活质量，心理健康症状的严重程度降低和自杀念头和行为，改善睡眠以及增加非药物和互补和综合性的利用率健康疼痛治疗。我们进一步假设治疗效果将持续到女性与男性农村退伍军人和那些被认为是白人非西班牙裔与少数化种族或种族的人。最后，我们将进行实施过程评估和逐步的成本效益分析，以告知开发实施工具包。研究结果将为乡村的远程推出的未来推出全国退伍军人。