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PCORnet Opioid Surveillance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03743493
Recruitment Status : Active, not recruiting
First Posted : November 16, 2018
Last Update Posted : March 29, 2019
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
National Patient-Centered Clinical Research Network
Research Action for Health Network (REACHnet)
Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER)
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
Information provided by (Responsible Party):
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.

Condition or disease
Opioid Use Opioid Abuse

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.

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Study Type : Observational
Estimated Enrollment : 22375112 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: PCORnet Opioid Surveillance Demonstration Project
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2019

Group/Cohort
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



Primary Outcome Measures :
  1. Opioid exposure (prescribing/dispensing) counts by Guideline A group [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts used to derive rates

  2. Opioid exposure (prescribing/dispensing) counts by Guideline B group [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts used to derive rates

  3. Opioid exposure (prescribing/dispensing) counts by Prevalance group [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts used to derive rates

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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


Secondary Outcome Measures :
  1. Characterization of opiate prescribing data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters with opiate prescription record

  2. Characterization of opiate dispensing data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters with opiate dispensing record

  3. Characterization of provider data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of providers from patient encounter records

  4. Characterization of prescribing provider data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of providers from patient opiate prescribing records

  5. Characterization of admitting source data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters by admitting source type (frequencies)

  6. Characterization of discharge disposition data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters by discharge disposition type (frequencies)

  7. Characterization of discharge status data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters by discharge status (frequencies)

  8. Characterization of facility data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Count of patient encounters by facility location/type (frequencies)

  9. Characterization of urine drug screen data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patients with a urine drug screen lab result record

  10. Characterization of urine drug screen results data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patients with a urine drug screen lab by result (frequencies)

  11. Characterization of prescription type data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient opiate prescriptions by RxNorm Term Types (frequencies)

  12. Characterization of prescription dose data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient opiate prescriptions by dose ordered unit of measure (frequencies)

  13. Distribution of prescription dose data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Distribution of patient opiate prescriptions by dose ordered

  14. Characterization of prescription dose frequency data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient opiate prescriptions by dose frequency (frequencies)

  15. Characterization of prescription supply data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Distribution of number of days supply of patient opiate prescriptions

  16. Characterization of prescription quantity data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Distribution of prescription quantity for patient opiate prescriptions

  17. Characterization of prescription refill data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Distribution of prescription refill numbers for patient opiate prescriptions

  18. Characterization of procedure data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient procedures by coding type (frequencies)

  19. Characterization of vitals data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient encounters with vitals records

  20. Characterization of smoking/tobacco data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Counts of patient vital records by smoking/tobacco type (frequencies)

  21. Characterization of language data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with language preference in record

  22. Characterization of primary payer data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with primary payer data in record

  23. Characterization of secondary payer data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with secondary payer data in record

  24. Characterization of height data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with height data in record

  25. Characterization of weight data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with weight data in record

  26. Characterization of diastolic blood pressure data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with diastolic data in record

  27. Characterization of systolic blood pressure data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with systolic data in record

  28. Characterization of dispensed days supply data for Guideline B patients [ Time Frame: 1/1/2010-12/31/2017 ]
    Percent completeness of patients with days supply in the dispensing record



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with electronic health record data from participating clinical data research networks (CDRN) of PCORnet.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743493


Locations
Show Show 24 study locations
Sponsors and Collaborators
Louisiana Public Health Institute
Patient-Centered Outcomes Research Institute
National Patient-Centered Clinical Research Network
Research Action for Health Network (REACHnet)
Patient-Centered SCAlable National Network for Effectiveness Research (pSCANNER)
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
Investigators
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Principal Investigator: 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
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Responsible Party: Louisiana Public Health Institute
ClinicalTrials.gov Identifier: NCT03743493    
Other Study ID Numbers: OpioidRCR
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders