EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder

EMBED：以用户为中心的临床决策支持的实用试验，以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍

• 批准号: 9928151
• 负责人: Gail D'Onofrio
• 金额: $ 38.22万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9928151
• 关键词: Accident and Emergency department; Adoption; Ambulatory Care; American; Appointment; Award; Buprenorphine; Caring; Clinic; Clinical; Clinical Decision Support Systems; Clinical Trials; Communities; Data; Data Collection; Data Coordinating Center; Distal; Eligibility Determination; Emergency Care; Emergency Department patient; Emergency department visit; Evaluation; Evidence Based Medicine; Family; Goals; Health; Health Services Accessibility; Healthcare Systems; Heroin; Individual; Infrastructure; Institutional Review Boards; Intervention; Intervention Studies; Investments; Medical; Medical Informatics; Medical center; North Carolina; Opioid agonist; Outcome; Outcome Measure; Patients; Phase; Physicians; Population; Pragmatic clinical trial; Process; Public Health; Science; Structure; Suboxone; Substance Use Disorder; Substance abuse problem; Testing; Training; United States National Institutes of Health; Universities; Withdrawal; addiction; capsule; clinical decision support; cohort; collaboratory; compare effectiveness; computerized; craving; data management; effective therapy; experience; health information technology; implementation trial; improved; incremental cost-effectiveness; innovation; intervention effect; medication-assisted treatment; opioid epidemic; opioid mortality; opioid use; opioid use disorder; pragmatic trial; prescription opioid addiction; prospective; protocol development; response; routine practice; screening; systems research; tool; treatment as usual; treatment strategy; treatment trial; trial design; uptake; usability; user centered design

Project Summary Opioid use disorder (OUD), dependence on prescription opioids and heroin, is a major public health problem taking a devastating toll on Americans, their families, and their communities. Three million Americans have or have had OUD. Opioid overdose deaths have quadrupled in the United Sates since 1999 (33,000 in 2015). Buprenorphine/naloxone (BUP), a partial opioid agonist combined with an antagonist, is a well-established outpatient treatment for OUD that can only be prescribed by appropriately trained physicians. Patients with untreated OUD often seek medical care in emergency departments (EDs). ED-initiated BUP doubles the rate of engagement in addiction treatment in ED patients with OUD. However, the practice of initiating BUP in the ED has not been implemented into ED care. Poor health information technology (HIT) usability is a major challenge to implementation of evidence-based medicine. To improve the HIT user experience and uptake of evidence-based medicine, HIT interventions should be developed using user-centered design. We propose a multicenter, pragmatic, stepped wedge implementation trial to evaluate the effect of user-centered computerized clinical decision support (CDS) for ED patients with OUD upon rates of ED-initiated BUP and referral for ongoing medication assisted treatment (MAT). The aims for the UG3 Planning Phase (Year 1) are: (1) Develop a pragmatic, user-centered CDS for ED-initiated BUP and referral for MAT in ED patients with OUD which will automatically identify and facilitate management of potentially eligible patients and (2) Establish the infrastructure for the proposed trial. In the UH3 Phase (Years 2-5) we will execute the trial with the specific aim to: Compare the effectiveness of user-centered CDS for BUP to usual care on outcomes in ED patients with OUD. We will test the primary implementation hypothesis that rates of ED-initiated BUP are higher with user-centered CDS. This trial will be pragmatic and offer advantages over more actively collected and distal outcomes by: (1) evaluating the effects of an intervention under the usual conditions in which it will be applied, (2) utilizing structured data from the EHR that can be passively collected, and (3) requiring no specific expertise or training of clinicians. Formative process evaluation, incremental cost effectiveness, and return on investment analyses will be performed to optimize the context for implementation of the user- centered CDS into routine ED practice and to evaluate its value. Given BUP's dramatic effect on engagement in treatment, this trial will answer the critical implementation question in OUD care: “What is the best way to maximize the rate of adoption of ED-initiated BUP and referral to MAT?" Our findings will have immediate and lasting impact upon individuals with OUD. Our collaborative network between Yale, the Mayo Clinic, and UNC is poised to efficiently carry out a trial of this design and magnitude. The study will be spearheaded by leading experts in ED-initiated treatment in substance abuse, user-centered health IT, and data management.

项目总结