PCORnet Opioid Surveillance Study

Opioid Use Clinical Trial

Official title:

PCORnet Opioid Surveillance Demonstration Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03743493
• Other study ID #: OpioidRCR
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: November 15, 2019

Study information

• Verified date: November 2020
• Source: Louisiana Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 15438284
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid Use
• Opioid-Related Disorders

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Fenway Health	Boston	Massachusetts
United States	Baylor Scott & White Health	Dallas	Texas
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	University of California - Irvine	Irvine	California
United States	University of California - San Diego	La Jolla	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of California - Los Angeles	Los Angeles	California
United States	University of Southern California	Los Angeles	California
United States	Health Choice Network	Miami	Florida
United States	Veteran's Affairs Health System	Nashville	Tennessee
United States	Research Action for Heath Network	New Orleans	Louisiana
United States	University Medical Center	New Orleans	Louisiana
United States	New York City Clinical Data Research Network	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Temple University	Philadelphia	Pennsylvania
United States	PaTH: Towards a Learning Health System Clinical Data Research Network	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	ADVANCE Clinical Data Research Network	Portland	Oregon
United States	OCHIN, Inc	Portland	Oregon
United States	University of Utah	Salt Lake City	Utah
United States	Patient-Centered SCAlable National Network for Effectiveness Research	San Diego	California
United States	University of California - San Francisco	San Francisco	California
United States	San Mateo Medical Center	San Mateo	California

Sponsors (10)

Lead Sponsor

Collaborator

Louisiana Public Health Institute

ADVANCE Clinical Data Research Network, Centers for Disease Control and Prevention, Harvard Pilgrim Health Care, National Patient-Centered Clinical Research Network, New York City Clinical Data Research Network, PaTH: Towards a Learning Health System Clinical Data Research Network, Patient-Centered Outcomes Research Institute, Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER), Research Action for Health Network (REACHnet)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid exposure (prescribing/dispensing) counts by Guideline A group	Counts used to derive rates	1/1/2010-12/31/2017
Primary	Opioid exposure (prescribing/dispensing) counts by Guideline B group	Counts used to derive rates	1/1/2010-12/31/2017
Primary	Opioid exposure (prescribing/dispensing) counts by Prevalance group	Counts used to derive rates	1/1/2010-12/31/2017
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Characterization of opiate prescribing data for Guideline B patients	Count of patient encounters with opiate prescription record	1/1/2010-12/31/2017
Secondary	Characterization of opiate dispensing data for Guideline B patients	Count of patient encounters with opiate dispensing record	1/1/2010-12/31/2017
Secondary	Characterization of provider data for Guideline B patients	Count of providers from patient encounter records	1/1/2010-12/31/2017
Secondary	Characterization of prescribing provider data for Guideline B patients	Count of providers from patient opiate prescribing records	1/1/2010-12/31/2017
Secondary	Characterization of admitting source data for Guideline B patients	Count of patient encounters by admitting source type (frequencies)	1/1/2010-12/31/2017
Secondary	Characterization of discharge disposition data for Guideline B patients	Count of patient encounters by discharge disposition type (frequencies)	1/1/2010-12/31/2017
Secondary	Characterization of discharge status data for Guideline B patients	Count of patient encounters by discharge status (frequencies)	1/1/2010-12/31/2017
Secondary	Characterization of facility data for Guideline B patients	Count of patient encounters by facility location/type (frequencies)	1/1/2010-12/31/2017
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Distribution of prescription dose data for Guideline B patients	Distribution of patient opiate prescriptions by dose ordered	1/1/2010-12/31/2017
Secondary	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
Secondary	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
Secondary	Characterization of prescription quantity data for Guideline B patients	Distribution of prescription quantity for patient opiate prescriptions	1/1/2010-12/31/2017
Secondary	Characterization of prescription refill data for Guideline B patients	Distribution of prescription refill numbers for patient opiate prescriptions	1/1/2010-12/31/2017
Secondary	Characterization of procedure data for Guideline B patients	Counts of patient procedures by coding type (frequencies)	1/1/2010-12/31/2017
Secondary	Characterization of vitals data for Guideline B patients	Counts of patient encounters with vitals records	1/1/2010-12/31/2017
Secondary	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
Secondary	Characterization of language data for Guideline B patients	Percent completeness of patients with language preference in record	1/1/2010-12/31/2017
Secondary	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
Secondary	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
Secondary	Characterization of height data for Guideline B patients	Percent completeness of patients with height data in record	1/1/2010-12/31/2017
Secondary	Characterization of weight data for Guideline B patients	Percent completeness of patients with weight data in record	1/1/2010-12/31/2017
Secondary	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
Secondary	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
Secondary	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