Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
PHARMSCREEN
2 other identifiers
observational
1,464
1 country
2
Brief Summary
The goal of the study is to validate a Prescription Drug Monitoring Program-based opioid risk metric to discriminate between low, moderate, and high-risk opioid use disorder. The World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST) will be used as the gold standard instrument that defines patient risk levels. No intervention or hypothesis will be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Typical duration for all trials
2 active sites
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
First Submitted
Initial submission to the registry
April 30, 2019
CompletedFirst Posted
Study publicly available on registry
May 3, 2019
CompletedStudy Start
First participant enrolled
November 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedResults Posted
Study results publicly available
July 11, 2024
CompletedJuly 11, 2024
July 1, 2024
1.8 years
April 30, 2019
January 24, 2024
July 9, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Validity of the PDMP Narcotic Score Versus the WHO ASSIST
To assess the validity of the PDMP Narcotic Score, the AUC (Area Under the Curve) was used. AUC ranges in value from 0 to 1. A model whose predictions are 100% wrong has an AUC of 0.0; one whose predictions are 100% correct has an AUC of 1.0. And when AUC is 0.5, it means the model has no means of separating between the different groups. For this study, the closer to 1.0 the more similar the PDMP Narcotic Score is to the WHO ASSIST.
The ASSIST was administered once at Day 1.
Eligibility Criteria
Adults 18 years or older, prescribed opioid medications from one of 15 participating pharmacies.
You may qualify if:
- be dispensed ≥1 opioid medication (including tramadol) by a participating pharmacy;
- be ≥18 years of age according to pharmacy data and self-report
You may not qualify if:
- solely filling buprenorphine or buprenorphine combination products i.e., patients receiving OUD treatment with no other opioid medication use;
- currently receiving treatment for cancer;
- having previously completed the survey;
- having current involvement with the criminal justice system that has, or could, lead to incarceration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- University of Cincinnaticollaborator
- Purdue Universitycollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (2)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (2)
Charron E, Brooks JH, Peterson KT, Akinwolere OG, Winhusen T, Cochran G. Mapping prescription drug monitoring program data to self-report measures of non-medical prescription opioid use in community pharmacy settings. Res Social Adm Pharm. 2023 Aug;19(8):1171-1177. doi: 10.1016/j.sapharm.2023.04.121. Epub 2023 Apr 23.
PMID: 37142474DERIVEDCharron E, Okifuji A, Bryan MA, Reese S, Brown JL, Ferguson A, Ghitza UE, Winhusen T, Cochran G. Pain Severity and Interference and Substance Use Among Community Pharmacy Patients Prescribed Opioids: A Secondary Analysis of the PHARMSCREEN Study. J Pain. 2022 Aug;23(8):1448-1459. doi: 10.1016/j.jpain.2022.03.238. Epub 2022 Apr 11.
PMID: 35417791DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerald (Jerry) Cochran, PhD
- Organization
- University of Utah
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 30, 2019
First Posted
May 3, 2019
Study Start
November 4, 2019
Primary Completion
August 30, 2021
Study Completion
May 31, 2023
Last Updated
July 11, 2024
Results First Posted
July 11, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share