PCORnet Opioid Surveillance Study
- Conditions
- Opioid UseOpioid Abuse
- Registration Number
- NCT03743493
- Lead Sponsor
- Louisiana Public Health Institute
- Brief Summary
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
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:
1. 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.
1. Identify the relevant data elements
2. Examine data completeness and validity
3. Identify data limitations and gaps that limit surveillance
The Aims of Phase II are:
1. Examine whether and to what extent patient-level risk factors, provider processes, and policies are associated with declines in outcomes of interest.
2. Examine whether and to what extent prescribing guidelines, related policies, processes, and/or care procedures are associated opioid-related outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15438284
• Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
• Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age 1/1/2010-12/31/2017 Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age 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 1/1/2010-12/31/2017 Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography 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 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 1/1/2010-12/31/2017 Counts used to derive rates
Most common diagnoses among cohort groups stratified by demographic characteristics and geography 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 1/1/2010-12/31/2017 Counts used to derive rates
Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics 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 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 1/1/2010-12/31/2017 Counts used to derive rates
Most common procedures among cohort groups stratified by demographic characteristics and geography 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 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 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 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 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) 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 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 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 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 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 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 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 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 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) 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 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 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 1/1/2010-12/31/2017 Patient level regression controlling for year, age, sex, race, ethnicity
Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing) 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 1/1/2010-12/31/2017 Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
- Secondary Outcome Measures
Name Time Method Characterization of vitals data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient encounters with vitals records
Characterization of height data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with height data in record
Characterization of systolic blood pressure data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with systolic data in record
Characterization of diastolic blood pressure data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with diastolic data in record
Characterization of admitting source data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters by admitting source type (frequencies)
Characterization of smoking/tobacco data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient vital records by smoking/tobacco type (frequencies)
Characterization of prescribing provider data for Guideline B patients 1/1/2010-12/31/2017 Count of providers from patient opiate prescribing records
Characterization of prescription quantity data for Guideline B patients 1/1/2010-12/31/2017 Distribution of prescription quantity for patient opiate prescriptions
Characterization of prescription refill data for Guideline B patients 1/1/2010-12/31/2017 Distribution of prescription refill numbers for patient opiate prescriptions
Characterization of urine drug screen results data for Guideline B patients 1/1/2010-12/31/2017 Counts of patients with a urine drug screen lab by result (frequencies)
Characterization of prescription type data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient opiate prescriptions by RxNorm Term Types (frequencies)
Characterization of prescription dose data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient opiate prescriptions by dose ordered unit of measure (frequencies)
Distribution of prescription dose data for Guideline B patients 1/1/2010-12/31/2017 Distribution of patient opiate prescriptions by dose ordered
Characterization of prescription dose frequency data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient opiate prescriptions by dose frequency (frequencies)
Characterization of procedure data for Guideline B patients 1/1/2010-12/31/2017 Counts of patient procedures by coding type (frequencies)
Characterization of opiate prescribing data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters with opiate prescription record
Characterization of discharge disposition data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters by discharge disposition type (frequencies)
Characterization of discharge status data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters by discharge status (frequencies)
Characterization of opiate dispensing data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters with opiate dispensing record
Characterization of urine drug screen data for Guideline B patients 1/1/2010-12/31/2017 Counts of patients with a urine drug screen lab result record
Characterization of provider data for Guideline B patients 1/1/2010-12/31/2017 Count of providers from patient encounter records
Characterization of facility data for Guideline B patients 1/1/2010-12/31/2017 Count of patient encounters by facility location/type (frequencies)
Characterization of prescription supply data for Guideline B patients 1/1/2010-12/31/2017 Distribution of number of days supply of patient opiate prescriptions
Characterization of language data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with language preference in record
Characterization of primary payer data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with primary payer data in record
Characterization of weight data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with weight data in record
Characterization of secondary payer data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with secondary payer data in record
Characterization of dispensed days supply data for Guideline B patients 1/1/2010-12/31/2017 Percent completeness of patients with days supply in the dispensing record
Trial Locations
- Locations (24)
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
PaTH: Towards a Learning Health System Clinical Data Research Network
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor Scott & White Health
🇺🇸Dallas, Texas, United States
University of California - San Diego
🇺🇸La Jolla, California, United States
University of California - Irvine
🇺🇸Irvine, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Patient-Centered SCAlable National Network for Effectiveness Research
🇺🇸San Diego, California, United States
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Health Choice Network
🇺🇸Miami, Florida, United States
Fenway Health
🇺🇸Boston, Massachusetts, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
New York City Clinical Data Research Network
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
OCHIN, Inc
🇺🇸Portland, Oregon, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Research Action for Heath Network
🇺🇸New Orleans, Louisiana, United States
University Medical Center
🇺🇸New Orleans, Louisiana, United States
ADVANCE Clinical Data Research Network
🇺🇸Portland, Oregon, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Veteran's Affairs Health System
🇺🇸Nashville, Tennessee, United States