Division of Biostatistics, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis, MN, USA.
Contemp Clin Trials. 2022 Oct;121:106905. doi: 10.1016/j.cct.2022.106905. Epub 2022 Aug 31.
Primary care is a frequent source of pain treatment and opioid prescribing. The objective of the Prescribing Interventions for Chronic Pain using the Electronic health record (PRINCE) study is to assess the effects of two behavioral economics-informed interventions embedded within the electronic health record (EHR) on guideline-concordant pain treatment and opioid prescribing decisions in primary care settings.
Setting: The setting for this study is 43 primary care clinics in Minnesota.
The PRINCE study uses a cluster-randomized 2 × 2 factorial design to test the effects of two interventions. An adaptive design allows for the possibility of secondary randomization to test if interventions can be titrated while maintaining efficacy.
One intervention alters the "choice architecture" within the EHR to nudge clinicians toward non-opioid treatments for opioid-naïve patients and toward tapering for patients currently receiving a "high risk" opioid. The other intervention integrates the prescription drug monitoring program (PDMP) directly within the EHR.
The primary outcome for opioid-naïve patients is whether an opioid is prescribed in a primary care visit without a non-opioid alternative pain treatment. The primary outcome for current opioid-using patients is whether opioid prescriptions were tapered with a documented rationale.
The PRINCE study will provide real-world evidence on two approaches to improving pain treatment in primary care using the EHR. The adaptive study design strikes a balance between establishing intervention efficacy and testing whether efficacy varies with intervention intensity.
初级保健是疼痛治疗和阿片类药物处方的主要来源。使用电子健康记录（PRINCE）进行慢性疼痛处方干预研究的目的是评估两种行为经济学指导的干预措施在电子健康记录（EHR）中对符合指南的疼痛治疗和阿片类药物处方决策的影响，这些干预措施在初级保健环境中。
设置：本研究的设置是明尼苏达州的 43 个初级保健诊所。
PRINCE 研究采用了集群随机 2×2 析因设计来测试两种干预措施的效果。适应性设计允许进行二次随机化的可能性，以测试干预措施是否可以在保持疗效的同时进行滴定。
一种干预措施改变了 EHR 中的“选择架构”，以促使临床医生为阿片类药物初治患者选择非阿片类药物治疗，并为当前接受“高风险”阿片类药物的患者选择减少剂量。另一种干预措施将处方药物监测计划（PDMP）直接集成到 EHR 中。
对于阿片类药物初治患者，主要结果是在初级保健就诊时是否开了阿片类药物而没有非阿片类替代疼痛治疗。对于当前使用阿片类药物的患者，主要结果是开阿片类药物处方是否减少，并附有记录的理由。
PRINCE 研究将提供使用 EHR 改善初级保健中疼痛治疗的两种方法的真实世界证据。适应性研究设计在确定干预效果和测试效果是否随干预强度而变化之间取得了平衡。
