Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool

NCT ID: NCT03936985

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1464 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2023-05-31

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.

Detailed Description

Fatal overdose deaths involving prescription opioids, heroin, and synthetic opioids has continued to increase across the US-continuing to increase in 35 states from 2013-2017. Given these persistent trends for adverse opioid-related outcomes in populations across the US, it is critical to work to identify those who are at risk, deliver appropriate care that will help prevent progression to more severe opioid-related outcomes, and provide referral and treatment resources to those who suffer from opioid use disorder. Therefore, it is necessary to expand the continuum of care to health care settings that previously may have been underutilized. One underutilized resource for addressing the current opioid epidemic is community pharmacies.The most important clinical tool pharmacists have available to identify possible misuse of opioid medications is prescription drug monitoring programs (PDMP),which capture patient-level prescription dispensing information to inform monitoring, dispensing decisions, and possible intervention.These tools are available in all US states and have the potential to enable pharmacists to identify patients at-risk for opioid-related adverse events, such as addiction and overdose. In light of the continued escalation of the opioid epidemic nationally, combined with the promising opportunities afforded by the further inclusion of community pharmacy settings for engaging patients with opioid-related risk, it is important to evaluate whether current PDMP risk metrics correlate with clinically validated opioid risk tools and if clinically meaningful risk cutoffs exist for PDMP risk metrics.

This study will evaluate the concurrent validity of a PDMP-based opioid risk metric as a clinical measure of high risk opioid use and establish clinically useful risk-level thresholds relative to the widely validated gold standard of the World Health Organization Alcohol, Smoking, and Substance Involvement Screening Test (WHO ASSIST). This study is a one group, cross-sectional, health assessment study. Participants who enroll in the study will complete on-line surveys at a single time point. Approximately 1,523 patients will be recruited from approximately 15 community community pharmacies. Trained pharmacy staff will inform potentially eligible participants, or individuals receiving at least one prescription(s) for potentially eligible participants, of the survey opportunity. Patients recruited will complete validated measures to assess opioid use and risk behaviors, substance use, and physical and mental health. A series of a priori analyses will be conducted to evaluate the validity of the PDMP-based opioid risk metric relative to the widely validated gold standard WHO ASSIST and to identify cutoff thresholds. Correlational, regression, and Cohen's Kappa statistical analyses will also be conducted to evaluate the relationship between the risk metric and the WHO ASSIST.

Conditions

Opioid Abuse; Prescription Drug Abuse (Not Dependent)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

1. be dispensed ≥1 opioid medication (including tramadol) by a participating pharmacy;

2. be ≥18 years of age according to pharmacy data and self-report

Exclusion Criteria

1. solely filling buprenorphine or buprenorphine combination products i.e., patients receiving OUD treatment with no other opioid medication use;

2. currently receiving treatment for cancer;

3. having previously completed the survey;

4. having current involvement with the criminal justice system that has, or could, lead to incarceration

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Cincinnati

OTHER

Sponsor Role: collaborator

Purdue University

OTHER

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Jerry Cochran

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Cincinnati

Cincinnati, Ohio, United States

University of Utah

Salt Lake City, Utah, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37142474 (View on PubMed)

Charron 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.

Reference Type: DERIVED

PMID: 35417791 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5UG1DA049444

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTN-0093

Identifier Type: -

Identifier Source: org_study_id