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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03936985

Recruitment Status Recruiting

First Posted May 3, 2019

Last update posted September 16, 2020

Study Description

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.

  • Condition or Disease:Opioid Abuse
    Prescription Drug Abuse (Not Dependent)
  • Intervention/Treatment:
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 1523 participants
  • Observational Model: Other
  • Time Perspective: Cross-Sectional
  • Official Title: Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
  • Actual Study Start Date: November 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: February 2022
Outcome Measures
  • Primary Outcome Measures: 1. Drug use severity [ Time Frame: 36 months ]
    Opioid use severity will be assessed using the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Adults 18 years or older, prescribed opioid medications from one of 15 participating pharmacies.
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

Contacts and Locations
Contacts

Contact: Gerald Cochran, PhD 801/213-0799 jerry.cochran@hsc.utah.edu

Contact: Jade Hill, BS 801/213/0798 jade.hill@hsc.utah.edu

Locations

United States, Ohio
University of Cincinnati
Cincinnati

United States, Utah
University of Utah
Salt Lake City

Sponsors and Collaborators

University of Utah

University of Cincinnati

Purdue University

National Institute on Drug Abuse (NIDA)

More Information
  • Responsible Party: University of Utah
  • ClinicalTrials.gov Identifier: NCT03936985 History of Changes
  • Other Study ID Numbers: CTN-0093, 5UG1DA049444
  • First Posted: May 3, 2019 Key Record Dates
  • Last Update Posted: September 16, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Opioid-Related Disorders Substance-Related Disorders