Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.
Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy.
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一项远程随机多中心临床试验的设计考虑，该试验评价了接受阿片类药物治疗的慢性疼痛患者的电子健康自我管理计划。
DOI：
10.1016/j.cct.2020.106245
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发表时间：
2021-03
影响因子：
2.2
通讯作者：
Vonder Meulen MB
中科院分区：
文献类型：
--
作者：
Winhusen T;Wilson M;Dolor RJ;Theobald J;Lewis D;Regan SL;Vonder Meulen MB
基于长期阿片类药物治疗(LOT)的不良后果和有效性证据不足，CDC提出了减少接受LOT患者使用LOT和吗啡当量剂量(MED)的建议。然而，这些患者中的大多数报告说，阿片类药物治疗对疼痛管理有显著的好处，并对减少/减少其使用犹豫不决。雪上加霜的是，由于保险报销结构和有限的疼痛服务可获得性，许多患者很难获得非药物治疗。Empower是一项意向治疗、双臂、开放标签、随机对照试验，在两个随机对照试验中评估了基于网络的自我管理慢性疼痛计划(E-Health)，该计划已被发现可以减少自我报告的MED，同时还可以减少疼痛。大约400名慢性疼痛患者在位于北卡罗来纳州和俄亥俄州的两个美国医疗保健系统之一接受每天平均处方的MED≥20毫克的Lot治疗，将以1：1的比例随机分为常规治疗(TAU)或TAU加E-Health(E-Health+)。Tau由开处方的临床医生提供的大量药物组成。电子健康+参与者可获得为期4个月的电子健康订阅(积极治疗阶段)。所有参与者将在基线、积极治疗阶段结束和积极治疗后6个月完成基于网络的自我报告措施。阿片类药物处方信息将从参与者的电子健康记录(EHR)中收集，从基线到积极治疗后6个月。本文描述了这项独特的试验的设计考虑因素，该试验完全远程进行，没有面对面的访问，并利用电子病历来识别参与者和收集初步结果。
Based on the adverse consequences and inadequate evidence of effectiveness for long-term opioid therapy (LOT), the CDC developed recommendations to decrease the use of LOT and morphine equivalent dose (MED) for patients receiving LOT. However, the majority of these patients report that opioid medication is significantly beneficial for pain management and are hesitant to reduce/decrease its use. Compounding the problem is poor access to nonpharmacologic therapies for many patients due to insurance reimbursement structures and limited pain-service availability. EMPOWER is an intent-to-treat, two-arm, open-label, randomized controlled trial evaluating a web-based self-management chronic pain program (E-health) that has been found to reduce self-reported MED, while also decreasing pain, in two randomized controlled trials. Approximately 400 chronic pain patients receiving LOT at a daily average prescribed MED ≥ 20 mg at one of two U.S. healthcare systems, located in North Carolina and Ohio, will be randomized in a 1:1 ratio to treatment as usual (TAU) or TAU plus E-health (E-health+). TAU consists of LOT from a prescribing clinician. E-health+ participants are provided with a 4-month E-health subscription (active treatment phase). All participants will complete web-based self-report measures at baseline, the end of the active treatment phase, and 6-months post-active treatment. Opioid prescription information will be collected from the participants’ electronic health record (EHR) from baseline through 6 months post-active treatment. This paper describes design considerations for this unique trial which is conducted completely remotely, with no in-person visits, and utilizes the EHR for participant identification and primary outcome collection.
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影响因子：
3.1
作者：
Frank, Joseph W.;Levy, Cari;Binswanger, Ingrid A.
通讯作者：
Binswanger, Ingrid A.
DOI：
10.1097/ajp.0b013e3181f195ba
发表时间：
2010-11
期刊：
The Clinical journal of pain
影响因子：
--
作者：
Butler SF;Budman SH;Fanciullo GJ;Jamison RN
通讯作者：
Jamison RN
影响因子：
7.4
作者：
Butler, Stephen F.;Budman, Simon H.;Jamison, Robert N.
通讯作者：
Jamison, Robert N.
影响因子：
3.6
作者：
Cramm JM;Strating MM;Tsiachristas A;Nieboer AP
通讯作者：
Nieboer AP
影响因子：
3.4
作者：
Bonomi, AE;Wagner, EH;VonKorff, M
通讯作者：
VonKorff, M