Machine-Learning Prediction and Reducing Overdoses With EHR Nudges
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,350
- 试验地点
- 2
- 主要终点
- Prescribing Practices Composite Score
研究概览
简要总结
The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose.
The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges/best practice alerts (BPAs) as compared to usual care by primary care clinicians.
The primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.
详细描述
In response to the opioid overdose crisis, health systems have instituted multiple interventions to reduce patient risk, including decreasing unsafe opioid prescribing among high-risk patients and dispensing naloxone. However, these interventions face two key challenges. First, there are limited and poorly performing tools to identify who is truly at risk of overdose, leading to burdensome interventions targeting an overly broad population or missing key high-risk individuals. Second, even with more accurate identification of high-risk patients, highly effective strategies to change clinician behavior remain limited. Common cognitive biases may underlie clinicians' lack of response to risk factors for overdose.
This project aims to address both of these limitations by combining more accurate risk prediction tools to identify those at elevated risk of opioid overdose with novel "nudge" interventions based on principles of behavioral economics that have been shown to address cognitive biases and change prescribing behavior. The primary hypothesis is that high-risk patients in primary care practices randomized to the elevated-risk flag + nudge intervention will have safer prescribing compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an opioid prescription within the past year
- •Age 18 years or older at the time of the opioid prescription
- •At least one visit to an internal medicine or family care practice within the past year
排除标准
- •Diagnosis of malignant cancer within the past year
- •Enrollment in hospice care
研究组 & 干预措施
EHR-Embedded Elevated-Risk Flag with Behavioral Nudges
An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose. This flag will be combined with a set of best practice alerts/behavioral nudges that will trigger when certain conditions are met during encounters with elevated-risk patients.
干预措施: EHR-Embedded Elevated-Risk Flag with Behavioral Nudges (Behavioral)
Usual Care
Patients in the practices randomized to the Usual Care arm will receive standard care practice without change.
干预措施: Usual Care (Behavioral)
EHR-Embedded Elevated-Risk Flag
An elevated-risk flag will be embedded in the EHR and prominently displayed in the chart during encounters for patients identified as having elevated-risk for opioid overdose.
干预措施: EHR-Embedded Elevated-Risk Flag (Behavioral)
结局指标
主要结局
Prescribing Practices Composite Score
时间窗: Assessed at 4 months following study enrollment (i.e., at 4 months after the first encounter in the study period. An encounter refers to the 1st primary care visit for a patient enrolled in the study.)
This outcome measures a composite of three prescribing practices associated with a reduced risk of opioid overdose. Each of the three is assigned a value of one point, with the composite score ranging from 0 to 3: 1. Naloxone prescription: Evidence of a prescription for naloxone. 2. Opioid dosage \< 50 morphine milligram equivalents (MME) per day: No prescriptions exceeding 50 MME/day during the measurement period. 3. No opioid and benzodiazepine overlap: No concurrent prescriptions for opioids and benzodiazepines. The composite score will be treated as a 3-point ordinal measure reflecting adherence to these prescribing practices.
次要结局
- Prescribing Practices Composite Score--6 Month Measure(Assessed at 6 months following study enrollment (i.e., at 6 months after the first encounter in the study period. An encounter refers to the 1st primary care visit for a patient enrolled in the study.))
- Active Naloxone Prescription(Assessed at 4 & 6 months after study enrollment by reviewing data from 12 months preceding index date (i.e., at 4 & 6 months after enrollment). An active naloxone prescription is recorded if one exists at any point during the year before the index date.)
- Average Daily Opioid Dosage > 50 MME(Assessed at 4 and 6 months after study enrollment, based on the average daily MME calculated over the 7 days preceding the index date (i.e., 4 and 6 months after enrollment).)
- Overlapping Opioid Benzodiazepine Prescriptions(Assessed at 4 and 6 months after study enrollment, based on overlap occurring on the index date (i.e., 4 and 6 months after enrollment) or within the 28 days preceding the index date.)
- Overlapping Opioid Benzodiazepine Prescriptions Where Average Daily Opioid MME > 50(Assessed at 4 and 6 months after study enrollment, based on overlap occurring on the index date (i.e., 4 and 6 months after enrollment) or within the 28 days preceding the index date.)
- Emergency Department or Inpatient Visits(Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).)
- Emergency Department or Inpatient Visits for Overdose(Assessed at 4 and 6 months after study enrollment, based on visits occurring within the 30 days prior to the index date (i.e., 4 and 6 months after enrollment).)
研究者
Walid Gellad
Professor of Medicine
University of Pittsburgh