Division
HEAL Study
Title
Validation of a Community Pharmacy-Based Prescription Drug Monitoring Program Risk Screening Tool
Short Description
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.
Release Date
Apr 13, 2023
Description

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.

Keywords
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Study Data
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Tobacco, Alcohol, Prescription Medication, and Other Substance Use Screening

Submitted by aplank on
Abbreviation
TAPS
Description

The TAPS Tool, developed by a study team in the NIDA Clinical Trials Network (CTN-0059), is a 2-step screening and brief assessment approach. TAPS-1, the screening component, asks about frequency of use of tobacco, alcohol (above guideline-recommended daily limits), illicit drugs, and nonmedical use of prescription medications within the previous 12 months. If the participants reports having used one of the substances, TAPS-2 then asks more specific follow-up questions regarding use in the past 3 months

Category
Substance Use

Prescription Opioid Misuse Index

Submitted by aplank on
Abbreviation
POMI
Description

This 6-item interview is focused specifically on prescription opioid use behaviors. It was developed and used in a larger study designed to assess correlates of OxyContin abuse in pain patients prescribed OxyContin, patients treated for OxyContin addiction, and individuals incarcerated for OxyContin-related charges. The original 8-item POMI included questions regarding dose, frequency of use, the need for early refills, a doctor expressing concern of misuse, feeling high from the medication, taking medication due to stress, obtaining prescriptions from multiple physicians, and pain control. It also included a question regarding adequate pain relief to confirm that any increase in prescription use reported was not due to inadequate pain control.

Category
Substance Use
Subcategory
Drugs
Division
HEAL Study
Title
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder
Short Description
This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial.
Release Date
Feb 16, 2023
Description

The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.

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Treatment Satisfaction Survey

Submitted by aplank on
Abbreviation
TSS
Description

Satisfaction with treatment delivery by participants will be measured using the Treatment Satisfaction Survey (adapted from Harland et al., 2005) at each visit. The proportion of visits in which participants are satisfied (score of 4 on a Likert Scale of 1-5) or very satisfied (score of 5 on a Likert Scale of 1-5) will be calculated.

Category
Health Cognitions & QOL