Rindal D Brad, Asche Stephen E, Gryczynski Jan, Kane Sheryl M, Truitt Anjali R, Shea Tracy L, Ziegenfuss Jeanette Y, Schwartz Robert P, Worley Donald C, Mitchell Shannon G
HealthPartners Institute, Bloomington, MN, United States.
Friends Research Institute Inc, Baltimore, MD, United States.
JMIR Res Protoc. 2021 Apr 12;10(4):e24342. doi: 10.2196/24342.
Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that, in most cases, the combination of ibuprofen and acetaminophen is an effective alternative to commonly prescribed opioid analgesics for the management of postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions.
We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions.
Using a prospective, 3-arm, cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to postimplementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for nonopioid analgesics, patients' perceptions of shared decision making, and patients' pain experiences following the extraction.
The HealthPartners Institutional Review Board approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested, and the protocol has been approved by the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms.
If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing.
ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24342.
处方阿片类镇痛药过量致死在美国一直是一场危机。阿片类镇痛药是牙医最常开具的药物之一。在美国，每年估计有500万人接受第三磨牙拔除术，术后会产生疼痛。研究表明，在大多数情况下，布洛芬和对乙酰氨基酚联合使用是治疗拔牙后疼痛的有效替代常用阿片类镇痛药的方法。然而，许多牙医在拔牙后仍常规开具阿片类药物。
我们描述了一项随机试验的基本原理、设计和方法，该试验旨在减少牙医开具阿片类药物的行为，同时在拔牙后使用有效的非阿片类镇痛药。
采用前瞻性、三臂、整群随机试验设计，以牙医作为随机分组单位，患者层面的处方数据作为主要结局指标，我们将比较不同策略，以减少对阿片类药物的依赖，并通过针对医护人员及其患者的信息支持工具增加替代疼痛管理方法的使用。该研究将测试两种干预措施在拔牙后减少阿片类药物处方的疗效：有患者教育的临床决策支持（CDS-E）和无患者教育的临床决策支持（CDS）。医护人员将被随机分配到CDS组、CDS-E组或标准治疗组。患者层面的结局将通过审查综合电子健康记录来确定。我们将比较各研究组在干预实施前后处方模式的差异变化。主要关注的结局指标是患者在拔牙当天是否接受阿片类药物处方的二元指标。我们还将检查非阿片类镇痛药的推荐或处方、患者对共同决策的看法以及拔牙后患者的疼痛体验。
健康伙伴机构审查委员会批准了该研究。所有研究材料，包括临床决策支持和患者教育材料均已开发并进行了预试验，该方案已获得国家牙科和颅面研究所的批准。干预措施于2020年2月实施，51名牙医被随机分配到三个组中的一组。
如果干预策略被证明是有效的，它们可以在阿片类药物处方量高的牙科环境中更广泛地实施。
ClinicalTrials.gov NCT03584789，https://clinicaltrials.gov/ct2/show/NCT03584789。
国际注册报告识别码（IRRID）：DERR1-10.2196/24342。
