PCORnet Opioid Surveillance Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Characterize data elements in PCORnet data and assess suitability for opioid surveillance. Identify the relevant data elements Examine data completeness and validity Identify data limitations and gaps that limit surveillance The Aims of Phase II are: Examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest. Examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.

Official Title
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PCORnet Opioid Surveillance Demonstration Project

Conditions
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Opioid Use, Opioid Abuse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17. Exclusion Criteria: • Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prevalence numerator<br>An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017) | |
| Prevalence denominator<br>Any diagnosis on record in the query period (1/1/2010-12/31/2017) | |
| Guideline A numerator<br>An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017) AND NO cancer diagnosis in the year prior to the index event | |
| Guideline A denominator<br>Any diagnosis on record in the query period (1/1/2010-12/31/2017) AND NO cancer diagnosis in the year prior to the index event | |
| Guideline B numerator<br>An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017) AND NO inpatient cancer diagnosis OR cancer procedure in the year prior to the index event | |
| Guideline B denominator<br>Any diagnosis on record in the query period (1/1/2010-12/31/2017) AND NO in-patient cancer diagnosis OR cancer procedure in the year prior to the index event | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid exposure (prescribing/dispensing) counts by Guideline A group | Counts used to derive rates | 1/1/2010-12/31/2017 | 
| Opioid exposure (prescribing/dispensing) counts by Guideline B group | Counts used to derive rates | 1/1/2010-12/31/2017 | 
| Opioid exposure (prescribing/dispensing) counts by Prevalance group | Counts used to derive rates | 1/1/2010-12/31/2017 | 
| Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics | Age group, sex, race and ethnicity; Counts used to derive rates | 1/1/2010-12/31/2017 | 
| Most common diagnoses among cohort groups stratified by demographic characteristics and geography | Frequencies of most common 1000 diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Most common procedures among cohort groups stratified by demographic characteristics and geography | Frequencies of most common 1000 procedure codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Occurrence of mental health diagnoses among cohort groups stratified by demographic characteristics and geography | Frequencies of mental health diagnosis codes stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography | Frequencies of opioid overdose stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography | Frequencies of substance use disorder diagnoses stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Opioid exposure (prescribing/dispensing) counts by cohort groups and provider | Stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Most common diagnoses in patients with opioid-inclusive substance use disorder diagnoses | Frequencies of most common 1000 diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Most common procedures among patients with opioid-inclusive substance use disorder diagnoses | Frequencies of most common 1000 procedure codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses | Frequencies of mental health diagnosis codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing) | Frequencies of urine drug screening procedures or lab codes overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of HIV diagnoses in patients with opioid use disorder diagnosis | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of Hepatitis B diagnoses in patients with opioid use disorder diagnosis | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of Hepatitis C diagnoses in patients with opioid use disorder diagnosis | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of opioid and benzodiazepine co-prescribing/dispensing | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of Naloxone administration during an emergency department encounter among patients with an opioid overdose diagnosis | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid exposure (prescribing/dispensing) by encounter setting | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of buprenorphine exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of naltrexone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Frequency of methadone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting | Counts overall and stratified by age group, sex, race, ethnicity, and facility 3-digit zip code | 1/1/2010-12/31/2017 | 
| Adjusted risk of overdose in patients with opioid exposure (prescribing/dispensing) | Patient level regression controlling for year, age, sex, race, ethnicity | 1/1/2010-12/31/2017 | 
| Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis | Patient level regression controlling for year, age, sex, race, ethnicity | 1/1/2010-12/31/2017 | 
| Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age | Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level | 1/1/2010-12/31/2017 | 
| Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age | Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level | 1/1/2010-12/31/2017 | 
| Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing) | Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level | 1/1/2010-12/31/2017 | 
| Adjusted risk of emergency department and inpatient utilization in patients with opioid-inclusive substance abuse disorder diagnosis | Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level | 1/1/2010-12/31/2017 | 
| Adjusted risk of emergency department and inpatient utilization in patients with opioid overdose diagnosis | Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level | 1/1/2010-12/31/2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of opiate prescribing data for Guideline B patients | Count of patient encounters with opiate prescription record | 1/1/2010-12/31/2017 | 
| Characterization of opiate dispensing data for Guideline B patients | Count of patient encounters with opiate dispensing record | 1/1/2010-12/31/2017 | 
| Characterization of provider data for Guideline B patients | Count of providers from patient encounter records | 1/1/2010-12/31/2017 | 
| Characterization of prescribing provider data for Guideline B patients | Count of providers from patient opiate prescribing records | 1/1/2010-12/31/2017 | 
| Characterization of admitting source data for Guideline B patients | Count of patient encounters by admitting source type (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of discharge disposition data for Guideline B patients | Count of patient encounters by discharge disposition type (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of discharge status data for Guideline B patients | Count of patient encounters by discharge status (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of facility data for Guideline B patients | Count of patient encounters by facility location/type (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of urine drug screen data for Guideline B patients | Counts of patients with a urine drug screen lab result record | 1/1/2010-12/31/2017 | 
| Characterization of urine drug screen results data for Guideline B patients | Counts of patients with a urine drug screen lab by result (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of prescription type data for Guideline B patients | Counts of patient opiate prescriptions by RxNorm Term Types (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of prescription dose data for Guideline B patients | Counts of patient opiate prescriptions by dose ordered unit of measure (frequencies) | 1/1/2010-12/31/2017 | 
| Distribution of prescription dose data for Guideline B patients | Distribution of patient opiate prescriptions by dose ordered | 1/1/2010-12/31/2017 | 
| Characterization of prescription dose frequency data for Guideline B patients | Counts of patient opiate prescriptions by dose frequency (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of prescription supply data for Guideline B patients | Distribution of number of days supply of patient opiate prescriptions | 1/1/2010-12/31/2017 | 
| Characterization of prescription quantity data for Guideline B patients | Distribution of prescription quantity for patient opiate prescriptions | 1/1/2010-12/31/2017 | 
| Characterization of prescription refill data for Guideline B patients | Distribution of prescription refill numbers for patient opiate prescriptions | 1/1/2010-12/31/2017 | 
| Characterization of procedure data for Guideline B patients | Counts of patient procedures by coding type (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of vitals data for Guideline B patients | Counts of patient encounters with vitals records | 1/1/2010-12/31/2017 | 
| Characterization of smoking/tobacco data for Guideline B patients | Counts of patient vital records by smoking/tobacco type (frequencies) | 1/1/2010-12/31/2017 | 
| Characterization of language data for Guideline B patients | Percent completeness of patients with language preference in record | 1/1/2010-12/31/2017 | 
| Characterization of primary payer data for Guideline B patients | Percent completeness of patients with primary payer data in record | 1/1/2010-12/31/2017 | 
| Characterization of secondary payer data for Guideline B patients | Percent completeness of patients with secondary payer data in record | 1/1/2010-12/31/2017 | 
| Characterization of height data for Guideline B patients | Percent completeness of patients with height data in record | 1/1/2010-12/31/2017 | 
| Characterization of weight data for Guideline B patients | Percent completeness of patients with weight data in record | 1/1/2010-12/31/2017 | 
| Characterization of diastolic blood pressure data for Guideline B patients | Percent completeness of patients with diastolic data in record | 1/1/2010-12/31/2017 | 
| Characterization of systolic blood pressure data for Guideline B patients | Percent completeness of patients with systolic data in record | 1/1/2010-12/31/2017 | 
| Characterization of dispensed days supply data for Guideline B patients | Percent completeness of patients with days supply in the dispensing record | 1/1/2010-12/31/2017 |