Community Pharmacists and Opioid Misuse

Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service

Opioid medication misuse and overdose have reached epidemic proportions in the US. Community pharmacy is a potentially valuable resource for addressing opioid medication misuse. This study will manualize and establish the feasibility, acceptability, and clinical effect of a community pharmacist-led intervention aimed at: improving opioid mediation regimen adherence, eliminating misuse, connecting patients to additional care, and safeguarding against overdose.

Study Overview

• Status: Completed
• Conditions: Opioid Misuse
• Intervention / Treatment: Behavioral: Standard Medication Counseling (SMC); Behavioral: Brief Intervention Medication Therapy Management

Detailed Description

The current small scale single-blinded randomized controlled study will build on our preliminary studies by manualizing and examining the feasibility, acceptability, and clinical effect for the Brief Intervention Medication Therapy Management (BI-MTM) model. BI-MTM is a multicomponent community pharmacy-based intervention. BI-MTM is designed to: (1) promote opioid medication regimen adherence, (2) reduce opioid medication misuse, (3) connect participants with patient navigation (a chronic condition care model) to increase self-management of health conditions that increase risk for misuse, and (4) provide naloxone rescue training referrals. Patients will be screened across 14 months for opioid medication misuse in an urban community pharmacy affiliated with a major medical system. Patients positive for misuse will be randomly assigned to BI-MTM (n=23) or Standard Medication Counseling (n=23). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling. This study will demonstrate feasibility and acceptability of BI-MTM for community pharmacy patients who misuse their opioid medications for future intervention implementation in a fully powered randomized trial. This study will also generate preliminary data regarding opioid medication misuse elimination and increases in participant self-management activation for comorbid health conditions that increase risk for misuse.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Falk Pharmacy
    • Somerset, Pennsylvania, United States, 15501
      • Medicine Shoppe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Opioid Misuse

  -≥18 years

• English speaking

Exclusion Criteria:

• Are pregnant (given potential pre/post-natal opioid use complications among pregnant women/offspring)
• Cannot provide collateral contact information for ≥2 contact persons (to ensure consistent contact/follow up)
• Do not have a reliable landline or mobile phone to be contacted by study staff
• Are only filling buprenorphine (given some formulations are not indicated for pain)
• Plan to leave the area for an extended period of time in the next 3 months
• Have had a psychotic and/or manic episode in the last 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SMC (n=23); Standard Medication Counseling.	Behavioral: Standard Medication Counseling (SMC); Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling.
Experimental: BI-MTM (n=23); Brief Intervention Medication Therapy Management.	Behavioral: Brief Intervention Medication Therapy Management; BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility	Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.	Month 21 of Study
Intervention acceptability	Intervention acceptability will be demonstrated though qualitative interviews.	Month 21 of Study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Misuse	Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).	Month 21 of Study
Patient Self-Management	Patient self-management activation misuse than will be captured by the Patient Activation Measure.	Month 21 of Study

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Gerald Cochran, Ph.D., University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (Actual): May 11, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Intervention; Medication Adherence; Pharmacy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: PRO17010410; R21DA043735 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No