Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care.
Study protocol for a type III hybrid effectiveness-implementation trial to evaluate scaling interoperable clinical decision support for patient-centered chronic pain management in primary care.
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DOI：
10.1186/s13012-022-01217-4
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发表时间：
2022-07-15
影响因子：
7.2
通讯作者：
Harle, Christopher A.
中科院分区：
文献类型：
--
作者：
Salloum, Ramzi G.;Bilello, Lori;Bian, Jiang;Diiulio, Julie;Paz, Laura Gonzalez;Gurka, Matthew J.;Gutierrez, Maria;Hurley, Robert W.;Jones, Ross E.;Martinez-Wittinghan, Francisco;Marcial, Laura;Masri, Ghania;McDonnell, Cara;Militello, Laura G.;Modave, Francois;Khoa Nguyen;Rhodes, Bryn;Siler, Kendra;Willis, David;Harle, Christopher A.
美国继续面临与慢性疼痛和阿片类药物过量有关的公共卫生危机。30%的美国人患有慢性非癌症疼痛，估计每年的成本超过6000亿美元。大多数慢性疼痛患者求助于初级保健临床医生，他们必须根据相对风险和好处、患者病史、可用资源、症状和目标从无数治疗方案中进行选择。最近，随着对阿片类药物相关风险的关注，处方数量有所下降。然而，临床专家反驳说，一些与阿片类药物相关的好处大于风险的患者可能会不适当地停止使用阿片类药物。不幸的是，初级保健临床医生缺乏可用的工具来帮助他们与患者合作选择疼痛治疗方案，在患者病史、资源、症状和目标的背景下最好地平衡风险和收益。因此，初级保健临床医生和患者将受益于这种共享决策过程的以患者为中心的临床决策支持(CDS)。这个为期3年的项目的目标是研究在One佛罗里达临床研究联盟的新临床环境中，在量身定制的实施支持下，现有的可互操作的CDS工具在疼痛治疗共享决策中的适应和实施。我们的中心假设是，量身定制的实施支持将增加CDS的采用和共享决策。我们进一步假设，共同决策的增加将导致患者结果的改善，特别是疼痛和身体功能。CDS的实施将以探索、准备、实施、持续(EPIS)框架为指导。评估将按REACH、有效性、采用、实施和维护(RE-AIM)框架组织。我们将调整和定制PainManager，这是一个开源的可互操作的CDS工具，用于在One佛罗里达临床研究联盟附属的初级保健诊所实施。我们将评估量身定制的实施支持对PainManager采用疼痛治疗共享决策的影响。这项评估将确定可行性并获得初步数据，为多地点务实试验做准备，目标是PainManager的有效性，以及在共享决策和患者报告的疼痛和身体功能方面提供量身定制的实施支持。这项研究将为在新的临床环境中跨不同类型的电子健康记录(EHR)实施可互操作的CDS的战略提供证据。这项研究还将为量身定做的执行战略提供信息，以便在随后的混合效力-执行试验中进一步测试。总之，这些努力将带来重要的新技术和证据，患者、临床医生和卫生系统可以利用这些技术和证据来改善数百万患有疼痛和其他慢性病的美国人的护理。ClinicalTrials.gov，NCT05256394，注册于2022年2月25日。网上版载有补充材料，可在10.1186/s13012-022-01217-4查阅。
The US continues to face public health crises related to both chronic pain and opioid overdoses. Thirty percent of Americans suffer from chronic noncancer pain at an estimated yearly cost of over $600 billion. Most patients with chronic pain turn to primary care clinicians who must choose from myriad treatment options based on relative risks and benefits, patient history, available resources, symptoms, and goals. Recently, with attention to opioid-related risks, prescribing has declined. However, clinical experts have countered with concerns that some patients for whom opioid-related benefits outweigh risks may be inappropriately discontinued from opioids. Unfortunately, primary care clinicians lack usable tools to help them partner with their patients in choosing pain treatment options that best balance risks and benefits in the context of patient history, resources, symptoms, and goals. Thus, primary care clinicians and patients would benefit from patient-centered clinical decision support (CDS) for this shared decision-making process. The objective of this 3-year project is to study the adaptation and implementation of an existing interoperable CDS tool for pain treatment shared decision making, with tailored implementation support, in new clinical settings in the OneFlorida Clinical Research Consortium. Our central hypothesis is that tailored implementation support will increase CDS adoption and shared decision making. We further hypothesize that increases in shared decision making will lead to improved patient outcomes, specifically pain and physical function. The CDS implementation will be guided by the Exploration, Preparation, Implementation, Sustainment (EPIS) framework. The evaluation will be organized by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. We will adapt and tailor PainManager, an open source interoperable CDS tool, for implementation in primary care clinics affiliated with the OneFlorida Clinical Research Consortium. We will evaluate the effect of tailored implementation support on PainManager’s adoption for pain treatment shared decision making. This evaluation will establish the feasibility and obtain preliminary data in preparation for a multi-site pragmatic trial targeting the effectiveness of PainManager and tailored implementation support on shared decision making and patient-reported pain and physical function. This research will generate evidence on strategies for implementing interoperable CDS in new clinical settings across different types of electronic health records (EHRs). The study will also inform tailored implementation strategies to be further tested in a subsequent hybrid effectiveness-implementation trial. Together, these efforts will lead to important new technology and evidence that patients, clinicians, and health systems can use to improve care for millions of Americans who suffer from pain and other chronic conditions. ClinicalTrials.gov, NCT05256394, Registered 25 February 2022. The online version contains supplementary material available at 10.1186/s13012-022-01217-4.
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
影响因子：
2.8
作者：
Boonstra A;Broekhuis M
通讯作者：
Broekhuis M
影响因子：
39.2
作者：
Bohnert, Amy S. B.;Guy, Gery P., Jr.;Losby, Jan L.
通讯作者：
Losby, Jan L.
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
影响因子：
4
作者：
Gaskin, Darrell J.;Richard, Patrick
通讯作者：
Richard, Patrick