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.

项目概要这项多中心、务实、随机临床试验的总体目标是适应和测试远程协作对生活在农村地区的退伍军人进行慢性疼痛的护理干预。在为期1年的UG3阶段，我们将应用基于证据的质量改进策略来调整我们的远程协作疼痛护理干预措施在四个不同地理位置的退伍军人事务部医疗机构中实施；试点和细化招聘，研究地点的干预和数据收集协议；并与疼痛管理部门合作协作协调中心，为在实验室中进行的所有活动制定标准操作程序 UH3临床试验阶段。参与小组将告知干预措施和所有组成部分的调整临床试验的方法。在为期 4 年的 UH3 阶段，我们将实施和评估在一项为期 12 个月的实用有效性试验中，对患有高影响慢性疼痛的农村退伍军人进行干预。我们计划从四个临床中心各招募 152 名退伍军人（总共 N=608），他们的出生性别、种族、和种族。参与者将被随机分配接受远程协作疼痛护理或最低限度的治疗加强平时护理。该干预措施基于协作护理模式，包括初始阶段由护士护理经理进行生物心理社会慢性疼痛评估、随访和参与疼痛教育集团。护士护理经理将接受疼痛科医生的咨询，参与者可以转诊接受针对慢性疼痛的非药物、补充和综合健康治疗。这护士护理经理还将跟进农村退伍军人，帮助他们在 VA 和社区卫生服务。我们假设接受远程协作疼痛护理的农村退伍军人，相对于最低程度增强的常规护理，将有证据表明疼痛严重程度和干扰减少，增加身体机能和生活质量、心理健康症状严重程度下降和自杀意念下降行为、改善睡眠以及增加非药物、补充和综合的利用健康疼痛治疗。我们进一步假设农村地区女性与男性的治疗效果将持续存在退伍军人和那些被认为是非西班牙裔白人与少数族裔或族裔的人。最后，我们将进行实施过程评估和增量成本效益分析，为发展提供信息一个实施工具包。研究结果将为未来在农村地区推出远程协作疼痛护理提供信息全国退伍军人。