The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.
The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain.
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DOI：
10.1016/j.cct.2021.106545
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发表时间：
2021-10
影响因子：
2.2
通讯作者：
Morone NE
中科院分区：
文献类型：
--
作者：
Greco CM;Gaylord SA;Faurot K;Weinberg JM;Gardiner P;Roth I;Barnhill JL;Thomas HN;Dhamne SC;Lathren C;Baez JE;Lawrence S;Neogi T;Lasser KE;Castro MG;White AM;Simmons SJ;Ferrao C;Binda DD;Elhadidy N;Eason KM;McTigue KM;Morone NE
基于正念的压力减轻(MBSR)是一种基于证据的非药理学方法，用于治疗慢性下腰痛(CLBP)，但在初级保健诊所并不容易获得或得到报销。希望避免开阿片类药物和其他药物的初级保健提供者(PCP)通常对他们的cLBP患者几乎没有选择。我们提出了一项实用的临床试验方案，题为最佳(使用正念优化医疗环境中的疼痛治疗)。最佳方案是通过远程健康在线提供的，包括带PCP的医疗团体探视(MGV)和模仿MBSR为慢性下腰痛患者提供的正念冥想干预。在美国不同的医疗保健环境中，如安全网医院、联邦合格的卫生中心和大型学术卫生系统，450名患者将被随机分配到MGV+MBSR或仅接受常规的PCP护理。参与者将在基线、8周计划之后以及6个月和12个月的随访中完成自我报告调查。卫生保健利用数据将通过电子健康记录和参与者完成的每月简要调查获得。主要的结果测量是6个月随访时的PEG值(疼痛、快乐和一般活动)。此外，我们还将评估心理功能、医疗资源使用和阿片类药物处方。这项试验是NIH Hear Initiative的一部分，通过将PCP就诊与仿照MBSR的非药物治疗相结合，有可能加强cLBP的初级保健治疗。由于它是在线提供的，并集成到初级保健中，因此预计它将可扩展，并可供服务不足的患者使用。
Mindfulness-based stress reduction (MBSR) is an evidence-based non-pharmacological approach for chronic low back pain (cLBP), yet it is not readily available or reimbursable within primary care clinics. Primary care providers (PCPs) who wish to avoid prescribing opioids and other medications typically have few options for their cLBP patients. We present the protocol of a pragmatic clinical trial entitled OPTIMUM (Optimizing Pain Treatment In Medical settings Using Mindfulness). OPTIMUM is offered online via telehealth and includes medical group visits (MGV) with a PCP and a mindfulness meditation intervention modeled on MBSR for persons with cLBP. In diverse health-care settings in the US, such as a safety net hospital, federally qualified health centers, and a large academic health system, 450 patients will be assigned randomly to the MGV+MBSR or to usual PCP care alone. Participants will complete self-report surveys at baseline, following the 8-week program, and at 6- and 12-month follow-up. Health care utilization data will be obtained through electronic health records and via brief monthly surveys completed by participants. The primary outcome measure is the PEG (Pain, enjoyment, and general activity) at the 6-month follow-up. Additionally, we will assess psychological function, healthcare resource use, and opioid prescriptions. This trial, which is part of the NIH HEAL Initiative, has the potential to enhance primary care treatment of cLBP by combining PCP visits with a non-pharmacological treatment modeled on MBSR. Because it is offered online and integrated into primary care, it is expected to be scalable and accessible to underserved patients.
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影响因子：
39.2
作者：
McNeely J;Wu LT;Subramaniam G;Sharma G;Cathers LA;Svikis D;Sleiter L;Russell L;Nordeck C;Sharma A;O'Grady KE;Bouk LB;Cushing C;King J;Wahle A;Schwartz RP
通讯作者：
Schwartz RP
影响因子：
3.1
作者：
Dresner, Danielle;Barnett, Katherine Gergen;Gardiner, Paula
通讯作者：
Gardiner, Paula
CDC规定慢性疼痛的阿片类药物的指南 - 美国，2016年。
DOI：
10.1001/jama.2016.1464
发表时间：
2016-04-19
期刊：
JAMA
影响因子：
--
作者：
Dowell D;Haegerich TM;Chou R
通讯作者：
Chou R
DOI：
10.1007/s11136-015-1178-1
发表时间：
2016-07
期刊：
Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation
影响因子：
--
作者：
Greco CM;Yu L;Johnston KL;Dodds NE;Morone NE;Glick RM;Schneider MJ;Klem ML;McFarland CE;Lawrence S;Colditz J;Maihoefer CC;Jonas WB;Ryan ND;Pilkonis PA
通讯作者：
Pilkonis PA
影响因子：
5.7
作者：
Krebs, Erin E.;Lorenz, Karl A.;Bair, Matthew J.;Damush, Teresa M.;Wu, Jingwei;Sutherland, Jason M.;Asch, Steven M.;Kroenke, Kurt
通讯作者：
Kroenke, Kurt