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个体化处方画像以减少初级保健中阿片类药物初治患者不合理使用阿片类药物镇痛:一项随机对照试验方案。

Individualized prescribing portraits to reduce inappropriate initiation of opioid analgesics to opioid naïve patients in primary care: Protocol for a randomized controlled trial.

机构信息

British Columbia Centre on Substance Use, 400-1045 Howe Street, Vancouver, BC V6Z 1Y6, Canada; Department of Family Practice, Innovation Support Unit, University of British Columbia, 5950 University Boulevard, Vancouver, BC V6T 1Z3, Canada.

British Columbia Centre on Substance Use, 400-1045 Howe Street, Vancouver, BC V6Z 1Y6, Canada.

出版信息

Contemp Clin Trials. 2021 Aug;107:106462. doi: 10.1016/j.cct.2021.106462. Epub 2021 May 31.

Abstract

Background Opioid analgesics are frequently initiated for chronic and acute pain despite weak evidence of benefit, although prescribing rates of some analgesics decreased in the context of the epidemic. In some populations, up to a quarter of opioid naïve persons prescribed opioids for non-cancer pain develop prescription opioid use disorder (OUD). Audit and feedback interventions rely on constructive use of routinely collected data to align professional behaviours and clinical practice with best evidence. These interventions have been shown to help reduce inappropriate initiation. However, effectiveness and acceptability of individualized "portraits" of physicians' prescribing patterns, to reduce inappropriate initiation of opioid analgesics to opioid naïve persons, have not been evaluated. Methods REDONNA is a mixed-methods randomized study testing the effectiveness of individualized prescribing Portraits to reduce inappropriate initiation of opioid analgesics. This intervention to improve safety of opioid prescribing in primary care in British Columbia (BC), Canada involves mailing individual prescribing portraits to an 'early group' of 2604 family physicians, followed in 6 months by a mailing to 2553 family physicians in the 'delayed group'. Primary outcome is number of new opioid prescriptions initiated in opioid naïve people, measured using administrative data from a centralized medication monitoring database covering all prescription opioids dispensed from BC community pharmacies. Secondary endpoints will compare prescribing impact between the two groups. A qualitative sub-study will examine feasibility among a purposive sample of physicians and patients. Discussion This trial provides important evidence on the intervention's potential to steer policy and practice on inappropriate opioid analgesics initiation. Trial registration: The study was registered prospectively on 30 March 2020 at the ISRCTN Register (https://www.isrctn.com/ISRCTN34246811).

摘要

背景 尽管证据表明益处有限,但阿片类镇痛药仍常被用于慢性和急性疼痛,尽管在疫情背景下某些镇痛药的处方率有所下降。在某些人群中,高达四分之一的首次接受阿片类药物治疗的非癌性疼痛患者会出现处方阿片类药物使用障碍(OUD)。审核和反馈干预措施依赖于对常规收集数据的建设性使用,以调整专业行为和临床实践与最佳证据保持一致。这些干预措施已被证明有助于减少不合理的起始治疗。然而,尚未评估针对医生处方模式的个体化“画像”以减少首次接受阿片类药物治疗的患者不合理起始使用阿片类药物的有效性和可接受性。

方法 REDONNA 是一项混合方法随机研究,旨在测试个体化处方画像以减少首次接受阿片类药物治疗的患者不合理起始使用阿片类药物的有效性。这项在加拿大不列颠哥伦比亚省(BC)改善初级保健中阿片类药物处方安全性的干预措施包括向 2604 名家庭医生的“早期组”邮寄个人处方画像,然后在 6 个月内向“延迟组”的 2553 名家庭医生邮寄。主要结局是通过集中药物监测数据库中的行政数据测量在首次接受阿片类药物治疗的人群中新开的阿片类药物处方数量,该数据库涵盖了从 BC 社区药房分发的所有处方阿片类药物。次要结局将比较两组之间的处方影响。一项定性子研究将在医生和患者的目的样本中检查可行性。

讨论 这项试验提供了关于该干预措施在指导政策和实践方面避免不合理起始使用阿片类镇痛药的潜力的重要证据。

试验注册

该研究于 2020 年 3 月 30 日在 ISRCTN 注册处(https://www.isrctn.com/ISRCTN34246811)前瞻性注册。

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