PCORnet Opioid Surveillance Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,438,284
- 试验地点
- 24
- 主要终点
- Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography
研究概览
简要总结
The overarching objective of this project is to demonstrate and assess the feasibility of using the Patient Centered Outcomes Research Network (PCORnet) Common Data Model for opioid surveillance to complement existing and support future initiatives. This project will characterize risk factors, processes, and outcomes related to opioid use, misuse, and abuse. It will quantify the utility of data stored in the PCORnet Common Data Model format stewarded by healthcare organizations participating in PCORnet.
详细描述
This is a two phase retrospective study. The goal of Phase I is to assess the utility of PCORnet Common Data Mode (CDM) data to study risk factors, processes, and outcomes related to opioid use, misuse, and abuse. Based on the results of the Phase I feasibility examination, Phase II will be conducted and will analyze the relationships between patient- and provider-level risk factors and policies, and opioid-related outcomes over time and within geographic regions.
The study will leverage the existing data PCORnet data infrastructure and resources to achieve its objectives and answer its research questions. Standardized analysis programs will be distributed to participating sites within the PCORnet Distributed Research Network. Sites will return aggregate, descriptive counts and summary statistics from regression analyses. When data are unavailable or analysis is determined infeasible, results will be reported as such.
The Aims of Phase I are:
- Generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system.
a. Compare results to CDC. 2. Characterize data elements in PCORnet data and assess suitability for opioid surveillance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
排除标准
- •Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
结局指标
主要结局
Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography
时间窗: 1/1/2010-12/31/2017
Frequencies of substance use disorder diagnoses stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses
时间窗: 1/1/2010-12/31/2017
Frequencies of mental health diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Opioid exposure (prescribing/dispensing) counts by Guideline A group
时间窗: 1/1/2010-12/31/2017
Counts used to derive rates
Most common diagnoses among cohort groups stratified by demographic characteristics and geography
时间窗: 1/1/2010-12/31/2017
Frequencies of most common 1000 diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Opioid exposure (prescribing/dispensing) counts by Guideline B group
时间窗: 1/1/2010-12/31/2017
Counts used to derive rates
Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics
时间窗: 1/1/2010-12/31/2017
Age group, sex, race and ethnicity; Counts used to derive rates
Occurrence of mental health diagnoses among cohort groups stratified by demographic characteristics and geography
时间窗: 1/1/2010-12/31/2017
Frequencies of mental health diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Opioid exposure (prescribing/dispensing) counts by Prevalance group
时间窗: 1/1/2010-12/31/2017
Counts used to derive rates
Most common procedures among cohort groups stratified by demographic characteristics and geography
时间窗: 1/1/2010-12/31/2017
Frequencies of most common 1000 procedure codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography
时间窗: 1/1/2010-12/31/2017
Frequencies of opioid overdose stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Most common diagnoses in patients with opioid-inclusive substance use disorder diagnoses
时间窗: 1/1/2010-12/31/2017
Frequencies of most common 1000 diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Most common procedures among patients with opioid-inclusive substance use disorder diagnoses
时间窗: 1/1/2010-12/31/2017
Frequencies of most common 1000 procedure codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Opioid exposure (prescribing/dispensing) counts by cohort groups and provider
时间窗: 1/1/2010-12/31/2017
Stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing)
时间窗: 1/1/2010-12/31/2017
Frequencies of urine drug screening procedures or lab codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of naltrexone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of HIV diagnoses in patients with opioid use disorder diagnosis
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of Hepatitis B diagnoses in patients with opioid use disorder diagnosis
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of Hepatitis C diagnoses in patients with opioid use disorder diagnosis
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of opioid and benzodiazepine co-prescribing/dispensing
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of Naloxone administration during an emergency department encounter among patients with an opioid overdose diagnosis
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid exposure (prescribing/dispensing) by encounter setting
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of methadone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Adjusted risk of overdose in patients with opioid exposure (prescribing/dispensing)
时间窗: 1/1/2010-12/31/2017
Patient level regression controlling for year, age, sex, race, ethnicity
Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Frequency of buprenorphine exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
时间窗: 1/1/2010-12/31/2017
Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis
时间窗: 1/1/2010-12/31/2017
Patient level regression controlling for year, age, sex, race, ethnicity
Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age
时间窗: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Adjusted risk of emergency department and inpatient utilization in patients with opioid-inclusive substance abuse disorder diagnosis
时间窗: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age
时间窗: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing)
时间窗: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Adjusted risk of emergency department and inpatient utilization in patients with opioid overdose diagnosis
时间窗: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
次要结局
- Characterization of opiate prescribing data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of discharge disposition data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of discharge status data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of opiate dispensing data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of urine drug screen data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of provider data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of facility data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescribing provider data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of admitting source data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of smoking/tobacco data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription supply data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription quantity data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription refill data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of urine drug screen results data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription type data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription dose data for Guideline B patients(1/1/2010-12/31/2017)
- Distribution of prescription dose data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of prescription dose frequency data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of procedure data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of vitals data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of height data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of systolic blood pressure data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of language data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of primary payer data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of weight data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of diastolic blood pressure data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of secondary payer data for Guideline B patients(1/1/2010-12/31/2017)
- Characterization of dispensed days supply data for Guideline B patients(1/1/2010-12/31/2017)