Opioid UseNCT03743493
PCORnet Opioid Surveillance Study
An observational study of Opioid Use and Opioid Abuse, run by Louisiana Public Health Institute at 24 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Use, Opioid Abuse
- How many people
- 15,438,284 participants
- Where
- 24 sitesUnited States
- Study dates
- 1 Jul 2018to 15 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.
Who may be able to join
- Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Who cannot join
- Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Johns Hopkins University
Baltimore, Maryland, 21202
Fenway Health
Boston, Massachusetts, 02115
Baylor Scott & White Health
Dallas, Texas, 75246
Penn State College of Medicine
Hershey, Pennsylvania, 17033
University of California - Irvine
Irvine, California, 92697
University of California - San Diego
La Jolla, California, 92093
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California - Los Angeles
Los Angeles, California, 90095
Health Choice Network
Miami, Florida, 33172
Veteran's Affairs Health System
Nashville, Tennessee, 37212
Research Action for Heath Network
New Orleans, Louisiana, 70112
University Medical Center
New Orleans, Louisiana, 70112
New York City Clinical Data Research Network
New York, New York, 10065
Weill Cornell Medicine
New York, New York, 10065
Temple University
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
PaTH: Towards a Learning Health System Clinical Data Research Network
Pittsburgh, Pennsylvania, 15260
ADVANCE Clinical Data Research Network
Portland, Oregon, 97201
OCHIN, Inc
Portland, Oregon, 97201
University of Utah
Salt Lake City, Utah, 84112
Patient-Centered SCAlable National Network for Effectiveness Research
San Diego, California, 92093
University of California - San Francisco
San Francisco, California, 94143
San Mateo Medical Center
San Mateo, California, 94403
About this study
Official title: PCORnet Opioid Surveillance Demonstration Project
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.
Read the 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:
- Generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system.
- 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.
- Conditions
- Opioid Use, Opioid Abuse
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid exposure (prescribing/dispensing) counts by Guideline A group
Counts used to derive rates
Measured: 1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts by Guideline B group
Counts used to derive rates
Measured: 1/1/2010-12/31/2017
Opioid exposure (prescribing/dispensing) counts by Prevalance group
Counts used to derive rates
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1/1/2010-12/31/2017
Secondary outcomes (28)
Characterization of opiate prescribing data for Guideline B patients
Count of patient encounters with opiate prescription record
Measured: 1/1/2010-12/31/2017
Characterization of opiate dispensing data for Guideline B patients
Count of patient encounters with opiate dispensing record
Measured: 1/1/2010-12/31/2017
Characterization of provider data for Guideline B patients
Count of providers from patient encounter records
Measured: 1/1/2010-12/31/2017
Characterization of prescribing provider data for Guideline B patients
Count of providers from patient opiate prescribing records
Measured: 1/1/2010-12/31/2017
Characterization of admitting source data for Guideline B patients
Count of patient encounters by admitting source type (frequencies)
Measured: 1/1/2010-12/31/2017
Characterization of discharge disposition data for Guideline B patients
Count of patient encounters by discharge disposition type (frequencies)
Measured: 1/1/2010-12/31/2017
Characterization of discharge status data for Guideline B patients
Count of patient encounters by discharge status (frequencies)
Measured: 1/1/2010-12/31/2017
Characterization of facility data for Guideline B patients
Count of patient encounters by facility location/type (frequencies)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 1/1/2010-12/31/2017
Distribution of prescription dose data for Guideline B patients
Distribution of patient opiate prescriptions by dose ordered
Measured: 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)
Measured: 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
Measured: 1/1/2010-12/31/2017
Characterization of prescription quantity data for Guideline B patients
Distribution of prescription quantity for patient opiate prescriptions
Measured: 1/1/2010-12/31/2017
Characterization of prescription refill data for Guideline B patients
Distribution of prescription refill numbers for patient opiate prescriptions
Measured: 1/1/2010-12/31/2017
Characterization of procedure data for Guideline B patients
Counts of patient procedures by coding type (frequencies)
Measured: 1/1/2010-12/31/2017
Characterization of vitals data for Guideline B patients
Counts of patient encounters with vitals records
Measured: 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)
Measured: 1/1/2010-12/31/2017
Characterization of language data for Guideline B patients
Percent completeness of patients with language preference in record
Measured: 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
Measured: 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
Measured: 1/1/2010-12/31/2017
Characterization of height data for Guideline B patients
Percent completeness of patients with height data in record
Measured: 1/1/2010-12/31/2017
Characterization of weight data for Guideline B patients
Percent completeness of patients with weight data in record
Measured: 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
Measured: 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
Measured: 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
Measured: 1/1/2010-12/31/2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start1 Jul 2018
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15,438,284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Patient-Centered Clinical Research Network, Research Action for Health Network (REACHnet), The Patient-Oriented Scalable National Network for Effectiveness Research, ADVANCE Clinical Data Research Network, New York City Clinical Data Research Network, PaTH: Towards a Learning Health System Clinical Data Research Network, Centers for Disease Control and Prevention, Harvard Pilgrim Health Care
- Responsible party
- Sponsor
- Investigators
- Kristin A Lyman, JD, MHA, Principal investigator, Louisiana Public Health InstituteDaniella Meeker, PhD, Principal investigator, University of Southern CaliforniaJason Doctor, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743493
- Sponsor's protocol ID
- OpioidRCR
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2018
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCORnet Opioid Surveillance Demonstration Project
- ClinicalTrials.gov ID
- NCT03743493
- Acronym / sponsor ID
- OpioidRCR
- Conditions
- Opioid Use, Opioid Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,438,284 participants (actual)
- Lead sponsor
- Louisiana Public Health InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, National Patient-Centered Clinical Research Network, Research Action for Health Network (REACHnet), The Patient-Oriented Scalable National Network for Effectiveness Research, ADVANCE Clinical Data Research Network, New York City Clinical Data Research Network, PaTH: Towards a Learning Health System Clinical Data Research Network, Centers for Disease Control and Prevention, Harvard Pilgrim Health Care
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Generate counts and proportion of patients with exposure (or potential exposure) to opioids though prescription or dispensing records within a health system.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.
Key inclusion criteria (1 listed)
- Patients with an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Key exclusion criteria (1 listed)
- Patients without an opioid exposure (prescription or dispense) or diagnosis from an encounter on record between 1/1/10-12/31/17.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioid exposure (prescribing/dispensing) counts by Guideline A group
Time frame: 1/1/2010-12/31/2017
Counts used to derive rates
Opioid exposure (prescribing/dispensing) counts by Guideline B group
Time frame: 1/1/2010-12/31/2017
Counts used to derive rates
Opioid exposure (prescribing/dispensing) counts by Prevalance group
Time frame: 1/1/2010-12/31/2017
Counts used to derive rates
Opioid exposure (prescribing/dispensing) counts stratified by demographic characteristics
Time frame: 1/1/2010-12/31/2017
Age group, sex, race and ethnicity; Counts used to derive rates
Most common diagnoses among cohort groups stratified by demographic characteristics and geography
Time frame: 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
Most common procedures among cohort groups stratified by demographic characteristics and geography
Time frame: 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 mental health diagnoses among cohort groups stratified by demographic characteristics and geography
Time frame: 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
Occurrence of opioid overdose diagnoses among cohort groups stratified by demographic characteristics and geography
Time frame: 1/1/2010-12/31/2017
Frequencies of opioid overdose stratified by age group, sex, race, ethnicity, and facility 3-digit zip code
Occurrence of substance use disorder diagnoses among cohort groups stratified by demographic characteristics and geography
Time frame: 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
Opioid exposure (prescribing/dispensing) counts by cohort groups and provider
Time frame: 1/1/2010-12/31/2017
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
Time frame: 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
Time frame: 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
Occurrence of mental health diagnoses among patients with opioid-inclusive substance use disorder diagnoses
Time frame: 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
Occurrence of urine drug screening in patients with opioid exposure (prescribing/dispensing)
Time frame: 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 HIV diagnoses in patients with opioid use disorder diagnosis
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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-inclusive substance use disorder diagnosis by encounter setting
Time frame: 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
Time frame: 1/1/2010-12/31/2017
Counts 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
Time frame: 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
Time frame: 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)
Time frame: 1/1/2010-12/31/2017
Patient level regression controlling for year, age, sex, race, ethnicity
Adjusted risk of overdose in patients with opioid-inclusive substance use disorder diagnosis
Time frame: 1/1/2010-12/31/2017
Patient level regression controlling for year, age, sex, race, ethnicity
Predictors of opioid exposure (prescribing/dispending) and rate of neonatal abstinence syndrome for women of child-bearing age
Time frame: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
Predictors of opioid-inclusive substance abuse disorder diagnosis and rate of neonatal abstinence syndrome for women of child-bearing age
Time frame: 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 exposure (prescribing/dispensing)
Time frame: 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
Time frame: 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
Time frame: 1/1/2010-12/31/2017
Regression controlling for year, age, race, ethnicity at patient and 3-digit zip code level
28 secondary outcomes
Characterization of opiate prescribing data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of opiate dispensing data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of provider data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescribing provider data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of admitting source data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of discharge disposition data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of discharge status data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of facility data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of urine drug screen data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of urine drug screen results data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription type data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription dose data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Distribution of prescription dose data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription dose frequency data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription supply data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription quantity data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of prescription refill data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of procedure data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of vitals data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of smoking/tobacco data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of language data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of primary payer data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of secondary payer data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of height data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of weight data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of diastolic blood pressure data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of systolic blood pressure data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Characterization of dispensed days supply data for Guideline B patients
Time frame: 1/1/2010-12/31/2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin A Lyman, JD, MHA principal investigator
Louisiana Public Health Institute
Daniella Meeker, PhD principal investigator
University of Southern California
Jason Doctor, PhD principal investigator
University of Southern California
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Opioid Abuse, run by Louisiana Public Health Institute at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid exposure (prescribing/dispensing) counts by Guideline A group (time frame: 1/1/2010-12/31/2017). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.