Partnered Evidence-based Policy Resource Center, VA Boston Healthcare System, Boston, Massachusetts, USA.
Bouvé College of Health Sciences, Northeastern University, Boston, Massachusetts, USA.
BMJ Open. 2018 Jun 27;8(6):e020097. doi: 10.1136/bmjopen-2017-020097.
There is an epidemic of opioid use related to adverse events and deaths in the USA. The rates of chronic pain, mental illness and substance use disorder are higher at the Veterans Health Administration (VHA) compared with the general US population. The 2016 Comprehensive Addiction and Recovery Act requires the VHA to improve opioid therapy strategies in treating patients and to ensure responsible prescribing practices. The Stratification Tool for Opioid Risk Mitigation (STORM) is a web-based dashboard that prioritises review of VHA patients receiving opioids based on their risk. The VHA Partnered Evidence-based Policy Resource Center is coordinating a multiyear evaluation of STORM and aspects of the VHA policy that mandate case review of patients identified by STORM as very high risk.
This stepped-wedge cluster randomised controlled trial will test two hypotheses: (1) VHA medical centres randomised to facilitation for not meeting the targeted case review rate will achieve lower opioid-related serious adverse events (SAEs), relative to facilities not randomised to facilitation and (2) Patients whose cases are required to be reviewed will have a lower rate of opioid-related SAEs compared with comparable risk patients whose cases are not required to be reviewed. Patients who receive an opioid prescription at VHA medical centres will be followed for a minimum of 3 months after their first opioid prescription. Follow-up will continue until the last day of the project or death. The data will be analysed using an intention-to-treat approach with patient-month-level Cox proportional hazards models for both interventions.
Evaluation of the randomised roll-out was approved by the VA Boston Healthcare System Institutional Review Board (IRB) and Research & Development Committees (Protocol # 3069). Findings will be published in peer-reviewed journals and presentations at national conference meetings.
ISRCTN16012111.
在美国，阿片类药物的使用与不良事件和死亡有关，出现了流行趋势。与普通美国人群相比，退伍军人健康管理局（VHA）的慢性疼痛、精神疾病和物质使用障碍的发病率更高。2016 年《综合成瘾和康复法案》要求 VHA 改善治疗患者的阿片类药物治疗策略，并确保负责任的处方实践。分层阿片类药物风险缓解工具（STORM）是一个基于网络的仪表板，根据患者的风险对接受阿片类药物治疗的 VHA 患者进行优先审查。VHA 合作循证政策资源中心正在协调对 STORM 以及要求根据 STORM 确定的极高风险患者进行病例审查的 VHA 政策的多个方面进行为期多年的评估。
这项阶梯式楔形集群随机对照试验将检验两个假设：（1）未达到目标病例审查率的 VHA 医疗中心随机接受促进措施，与未随机接受促进措施的设施相比，阿片类药物相关严重不良事件（SAE）的发生率将更低；（2）需要进行病例审查的患者的阿片类药物相关 SAE 发生率将低于不需要进行病例审查的具有可比性风险患者。在 VHA 医疗中心接受阿片类药物处方的患者将在首次开具阿片类药物处方后至少 3 个月进行随访。随访将持续到项目结束或患者死亡。将使用意向治疗方法对数据进行分析，对两种干预措施分别采用患者月水平 Cox 比例风险模型。
VA 波士顿医疗保健系统机构审查委员会（IRB）和研究与发展委员会（Protocol # 3069）批准了对随机推出的评估。研究结果将发表在同行评议的期刊上，并在全国会议上进行介绍。
ISRCTN16012111。
