NCT03743493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,438,284

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

October 26, 2018

Last Update Submit

November 10, 2020

Conditions

Opioid UseOpioid Abuse

Outcome Measures

Primary Outcomes (31)

  • 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 Outcomes (28)

  • Characterization of opiate prescribing 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 provider 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

  • +23 more secondary outcomes

Study Arms (6)

Prevalence numerator

An opioid prescribed or dispensed in the query period (1/1/2010-12/31/2017)

Prevalence denominator

Any diagnosis on record in the query period (1/1/2010-12/31/2017)

Guideline A numerator

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

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

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

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.

You may qualify if:

  • Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.

You may not qualify if:

  • Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

University of California - Irvine

Irvine, California, 92697, United States

Location

University of California - San Diego

La Jolla, California, 92093, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

Patient-Centered SCAlable National Network for Effectiveness Research

San Diego, California, 92093, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

San Mateo Medical Center

San Mateo, California, 94403, United States

Location

Health Choice Network

Miami, Florida, 33172, United States

Location

Research Action for Heath Network

New Orleans, Louisiana, 70112, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21202, United States

Location

Fenway Health

Boston, Massachusetts, 02115, United States

Location

New York City Clinical Data Research Network

New York, New York, 10065, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

ADVANCE Clinical Data Research Network

Portland, Oregon, 97201, United States

Location

OCHIN, Inc

Portland, Oregon, 97201, United States

Location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

PaTH: Towards a Learning Health System Clinical Data Research Network

Pittsburgh, Pennsylvania, 15260, United States

Location

Veteran's Affairs Health System

Nashville, Tennessee, 37212, United States

Location

Baylor Scott & White Health

Dallas, Texas, 75246, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kristin A Lyman, JD, MHA

    Louisiana Public Health Institute

    PRINCIPAL INVESTIGATOR

  • Daniella Meeker, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Jason Doctor, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 16, 2018

Study Start

July 1, 2018

Primary Completion

November 15, 2019

Study Completion

November 15, 2019

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

US(24)