Bachhuber Marcus A, Nash Denis, Southern William N, Heo Moonseong, Berger Matthew, Schepis Mark, Cunningham Chinazo O
Division of General Internal Medicine, Montefiore Medical Center/Albert Einstein College of Medicine, New York City, New York, USA.
Institute for Implementation Science in Population Health, City University of New York (CUNY), New York City, New York, USA.
BMJ Open. 2018 Apr 20;8(4):e019559. doi: 10.1136/bmjopen-2017-019559.
As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising intervention to reduce prescribing.
This study is a prospective cluster randomised controlled trial with two parallel arms. Primary care sites (n=32) and emergency departments (n=4) will be randomised in matched pairs to either a modification of the EHR so that new opioid analgesic prescriptions default to a dispense quantity of 10 tablets (intervention) or to no EHR change (control). The dispense quantity will remain fully modifiable by providers in both arms. From 6 months preintervention to 18 months postintervention, patient-level data will be analysed (ie, the patient is the unit of inference). Patient eligibility criteria are: (A) received a new opioid analgesic prescription, defined as no other opioid analgesic prescription in the prior 6 months; (B) age ≥18 years; and (C) no cancer diagnosis within 1 year prior to the new opioid analgesic prescription. The primary outcome will be the quantity of opioid analgesics prescribed in the initial prescription. Secondary outcomes will include opioid analgesic reorders and health service utilisation within 30 days after the initial prescription. Outcomes will be compared between study arms using a difference-in-differences analysis.
This study has been approved by the Montefiore Medical Center/Albert Einstein College of Medicine Institutional Review Board with a waiver of informed consent (2016-6036) and is registered on ClinicalTrials.gov (NCT03003832, 6 December 2016). Findings will be disseminated through publication, conferences and meetings with health system leaders.
NCT03003832; Pre-results.
随着阿片类镇痛药使用量的增加，阿片类药物使用障碍及与阿片类药物相关的过量用药情况也在增多。减少为急性非癌性疼痛开具的阿片类镇痛药数量，有可能降低接受处方者以及可能无意或有意服用任何剩余药片的其他人的风险。在电子健康记录（EHR）中减少新的阿片类镇痛药处方的默认配药量，是一种很有前景的减少处方开具的干预措施。
本研究是一项前瞻性整群随机对照试验，有两个平行组。初级保健机构（n = 32）和急诊科（n = 4）将按匹配对随机分组，一组对EHR进行修改，使新的阿片类镇痛药处方默认配药量为10片（干预组），另一组EHR不做更改（对照组）。两组中，配药量仍可由医护人员完全修改。从干预前6个月到干预后18个月，将对患者层面的数据进行分析（即患者为推断单位）。患者入选标准为：（A）接受新的阿片类镇痛药处方，定义为在过去6个月内未开具其他阿片类镇痛药处方；（B）年龄≥18岁；（C）在开具新的阿片类镇痛药处方前1年内无癌症诊断。主要结局将是初始处方中开具的阿片类镇痛药数量。次要结局将包括阿片类镇痛药的再次开药情况以及初始处方后30天内的医疗服务利用情况。将使用差分分析在研究组之间比较结局。
本研究已获得蒙特菲奥里医疗中心/阿尔伯特·爱因斯坦医学院机构审查委员会批准，豁免知情同意（2016 - 6036），并在ClinicalTrials.gov上注册（NCT03003832，2016年12月6日）。研究结果将通过发表文章、参加会议以及与卫生系统领导者会面等方式进行传播。
NCT03003832；预结果
