Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, 760 Press Avenue, Ste. 260, Lexington, KY, 40536, USA.
Department of Biostatistics, College of Public Health, University of Kentucky, Lexington, KY, USA.
BMC Oral Health. 2024 Apr 4;24(1):414. doi: 10.1186/s12903-024-04201-0.
Dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. Most opioids are prescribed after tooth extraction, but non-opioid analgesics provide similar analgesia and are recommended by multiple professional organizations.
This multi-site stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists/oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of prescriber education via academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen and ibuprofen. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics. The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to usual practice. Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management. Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.).
This real-world study will address an important need, providing information on the effectiveness of a multicomponent intervention at modifying dental prescribing behavior and reducing opioid prescriptions to AYA.
GOV: NCT06275191.
牙医和口腔外科医生是向青少年和年轻人(AYA)开具阿片类药物的主要医生,他们在首次接触后有很高的发展成问题性阿片类药物使用的风险。大多数阿片类药物是在拔牙后开具的,但非阿片类镇痛药提供类似的镇痛效果,并得到多个专业组织的推荐。
这项多地点、阶梯式楔形群随机试验将评估一种多成分行为干预措施是否可以影响牙医和口腔外科医生的阿片类药物处方行为,与常规做法相比。在多达 12 个临床实践点(集群)中,多达 33 名牙医/口腔外科医生(提供者参与者)将被招募,他们为 12-25 岁的个体进行拔牙。在入组后,所有提供者参与者将根据其所在集群的随机顺序在特定时间内接受干预。干预措施包括通过学术详细信息进行处方医生教育,以及提供标准化的患者拔牙后说明和乙酰氨基酚和布洛芬的泡罩包装。提供者参与者将自行决定向接受拔牙的 AYA 分发泡罩包装和分发患者说明,无论是否使用额外的镇痛药。主要结果是电子拔牙后阿片类药物处方的二元、患者水平指标。在整个研究过程中,将每季度从提供者参与者的电子健康记录中收集主要结局数据。提供者参与者将在过渡到干预条件之前和大约 3 个月后完成一项调查,以评估实施结果。接受拔牙的 AYA 患者将被提供一项调查,以评估他们在拔牙后一周的疼痛控制和对疼痛管理的满意度。主要分析将使用广义估计方程比较干预条件下与常规做法相比患者水平的阿片类药物处方指标。次要分析将评估提供者参与者对干预措施的可行性和适当性的看法,以及患者报告的疼痛控制和对疼痛管理的满意度。分析将调整患者水平因素(例如,性别、拔牙数量等)。
这项真实世界的研究将满足一个重要需求,提供有关多成分干预措施改变牙科处方行为和减少 AYA 阿片类药物处方的有效性信息。
美国政府:NCT06275191。