Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.
Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial.
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慢性疼痛的认知行为疗法（CBT-CP）是一种有效但未充分使用的高影响慢性疼痛治疗方法。增加获得CBT-CP疼痛服务的机会具有关键的公共卫生重要性，特别是对于农村和医疗服务不足的人群，由于这些服务集中在城市和高收入地区，他们的机会有限。使CBT-CP广泛可用且更便宜可以减少CBT-CP使用的障碍。作为美国国立卫生研究院帮助结束长期成瘾®（NIH HEAL）计划的一部分，我们设计并实施了一项比较有效性的3臂随机对照试验，将远程提供的电话/视频和基于CBT-CP的在线服务与高影响慢性疼痛患者的常规护理进行比较。RESOLVE试验正在位于明尼苏达州、格鲁吉亚、俄勒冈州和华盛顿州的4个大型综合医疗保健系统中进行，包括居住在城市和农村地区的人口统计学上多样化的人群。该试验比较了（1）8节，一对一，专业提供的电话/视频CBT-CP计划;（2）先前开发和测试的8节在线CBT-CP计划（painTRAINER）与（3）通过慢性疼痛管理书面指南增强的常规护理。参与者在分配后随访1年，并在基线和分配后3、6和12个月进行评估。主要结局是3个月时通过改良的11项简明疼痛量表简表评估的疼痛严重程度（疼痛强度和疼痛相关干扰的复合）的最小临床重要差异（MCID;降低≥ 30%）。次要结局包括疼痛严重程度、疼痛强度和疼痛相关干扰评分、生活质量指标以及患者在3、6和12个月时的总体变化印象。通过主要结局中每增加一例MCID患者的增量成本和每达到质量调整生命年的成本来评估成本-效果。结局评估对分组设盲。这项大规模试验提供了一个独特的机会，可以严格评估和比较两种相对低成本和可扩展的模式的临床和成本效益，为患有高影响慢性疼痛的人提供基于CBT-CP的治疗，包括居住在农村和其他医疗服务不足地区的人，这些服务有限。ClinicalTrials.gov NCT04523714。该试验于2020年8月24日登记。
Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use. As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment. This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services. ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020.
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影响因子：
7.6
作者：
BARON, RM;KENNY, DA
通讯作者：
KENNY, DA
影响因子：
7.4
作者：
Allen, Kelli D.;Somers, Tamara J.;Keefe, Francis J.
通讯作者：
Keefe, Francis J.
DOI：
10.1111/j.1526-4637.2009.00707.x
发表时间：
2009-10
期刊：
Pain medicine (Malden, Mass.)
影响因子：
--
作者：
Bair MJ;Matthias MS;Nyland KA;Huffman MA;Stubbs DL;Kroenke K;Damush TM
通讯作者：
Damush TM
影响因子：
39.2
作者：
DeBar L;Mayhew M;Benes L;Bonifay A;Deyo RA;Elder CR;Keefe FJ;Leo MC;McMullen C;Owen-Smith A;Smith DH;Trinacty CM;Vollmer WM
通讯作者：
Vollmer WM
DOI：
10.1001/jama.2016.2323
发表时间：
2016-03-22
期刊：
JAMA
影响因子：
--
作者：
Cherkin DC;Sherman KJ;Balderson BH;Cook AJ;Anderson ML;Hawkes RJ;Hansen KE;Turner JA
通讯作者：
Turner JA