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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03936985
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : January 30, 2020
University of Cincinnati
Purdue University
Information provided by (Responsible Party):
Jerry Cochran, University of Utah

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)

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.

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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 4, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : February 28, 2022

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)

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:   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.

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

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 identifier (NCT number): NCT03936985

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Contact: Gerald Cochran, PhD 801/213-0799
Contact: Jade Hill, BS 801/213/0798

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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Theresa Winhusen, PhD    513-585-8292   
Contact: Andrew Ferguson, B.S.    513-585-8294      
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84108
Contact: Gerald T Cochran, PhD, MSW    801-213-0654   
Contact: Myranda A Bryan, MSW    801-213-0795   
Sponsors and Collaborators
University of Utah
University of Cincinnati
Purdue University
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Responsible Party: Jerry Cochran, Associate Professor, University of Utah Identifier: NCT03936985    
Other Study ID Numbers: CTN-0093
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Substance-Related Disorders
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders