Clinical trial NCT03743493: PCORnet Opioid Surveillance Study
Official title: PCORnet Opioid Surveillance Demonstration Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Use
Opioid Abuse
Lead sponsor: Louisiana Public Health Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: National Patient-Centered Clinical Research Network
name: Research Action for Health Network (REACHnet)
name: The Patient-Oriented Scalable National Network for Effectiveness Research
name: ADVANCE Clinical Data Research Network
name: New York City Clinical Data Research Network
name: PaTH: Towards a Learning Health System Clinical Data Research Network
name: Centers for Disease Control and Prevention
name: Harvard Pilgrim Health Care
First posted: 2018-11-16
Enrollment: 15438284
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opioid exposure (prescribing/dispensing) counts by Guideline A group
timeFrame: 1/1/2010-12/31/2017
measure: Opioid exposure (prescribing/dispensing) counts by Guideline B group
timeFrame: 1/1/2010-12/31/2017
measure: Opioid exposure (prescribing/dispensing) counts by Prevalance group
timeFrame: 1/1/2010-12/31/2017
measure: Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics
timeFrame: 1/1/2010-12/31/2017
measure: Most common diagnoses among cohort groups stratified by demographic characteristics and geography
timeFrame: 1/1/2010-12/31/2017
measure: Most common procedures among cohort groups stratified by demographic characteristics and geography
timeFrame: 1/1/2010-12/31/2017
measure: Occurrence of mental health diagnoses among cohort groups stratified by demographic characteristics and geography
timeFrame: 1/1/2010-12/31/2017
measure: Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography
timeFrame: 1/1/2010-12/31/2017
measure: Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography
timeFrame: 1/1/2010-12/31/2017
measure: Opioid exposure (prescribing/dispensing) counts by cohort groups and provider
timeFrame: 1/1/2010-12/31/2017
measure: Most common diagnoses in patients with opioid-inclusive substance use disorder diagnoses
timeFrame: 1/1/2010-12/31/2017
measure: Most common procedures among patients with opioid-inclusive substance use disorder diagnoses
timeFrame: 1/1/2010-12/31/2017
measure: Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses
timeFrame: 1/1/2010-12/31/2017
measure: Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing)
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of HIV diagnoses in patients with opioid use disorder diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of Hepatitis B diagnoses in patients with opioid use disorder diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of Hepatitis C diagnoses in patients with opioid use disorder diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of opioid and benzodiazepine co-prescribing/dispensing
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of Naloxone administration during an emergency department encounter among patients with an opioid overdose diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid exposure (prescribing/dispensing) by encounter setting
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of Naloxone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of buprenorphine exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of naltrexone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
timeFrame: 1/1/2010-12/31/2017
measure: Frequency of methadone exposure (prescribing/dispensing) among patients with opioid-inclusive substance use disorder diagnosis by encounter setting
timeFrame: 1/1/2010-12/31/2017
measure: Adjusted risk of overdose in patients with opioid exposure (prescribing/dispensing)
timeFrame: 1/1/2010-12/31/2017
measure: Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age
timeFrame: 1/1/2010-12/31/2017
measure: Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age
timeFrame: 1/1/2010-12/31/2017
measure: Adjusted risk of emergency department and inpatient utilization in patients with opioid exposure (prescribing/dispensing)
timeFrame: 1/1/2010-12/31/2017
measure: Adjusted risk of emergency department and inpatient utilization in patients with opioid-inclusive substance abuse disorder diagnosis
timeFrame: 1/1/2010-12/31/2017
measure: Adjusted risk of emergency department and inpatient utilization in patients with opioid overdose diagnosis
timeFrame: 1/1/2010-12/31/2017
Secondary outcomes:
measure: Characterization of opiate prescribing data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of opiate dispensing data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of provider data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescribing provider data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of admitting source data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of discharge disposition data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of discharge status data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of facility data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of urine drug screen data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of urine drug screen results data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription type data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription dose data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Distribution of prescription dose data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription dose frequency data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription supply data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription quantity data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of prescription refill data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of procedure data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of vitals data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of smoking/tobacco data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of language data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of primary payer data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of secondary payer data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of height data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of weight data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of diastolic blood pressure data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of systolic blood pressure data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
measure: Characterization of dispensed days supply data for Guideline B patients
timeFrame: 1/1/2010-12/31/2017
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California - Irvine
state: California
city: La Jolla
country: United States
facility: University of California - San Diego
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: San Diego
country: United States
facility: Patient-Centered SCAlable National Network for Effectiveness Research
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: San Mateo
country: United States
facility: San Mateo Medical Center
state: California
city: Miami
country: United States
facility: Health Choice Network
state: Florida
city: New Orleans
country: United States
facility: Research Action for Heath Network
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
city: New York
country: United States
facility: New York City Clinical Data Research Network
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Portland
country: United States
facility: ADVANCE Clinical Data Research Network
state: Oregon
city: Portland
country: United States
facility: OCHIN, Inc
state: Oregon
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: PaTH: Towards a Learning Health System Clinical Data Research Network
state: Pennsylvania
city: Nashville
country: United States
facility: Veteran's Affairs Health System
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Health
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Louisiana Public Health Institute
name: Kristin A Lyman, JD, MHA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Daniella Meeker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Jason Doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References: