Community Pharmacists and Opioid Misuse

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Opioid Misuse

Intervention / Treatment
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* Behavioral: Brief Intervention Medication Therapy Management
* Behavioral: Standard Medication Counseling (SMC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMC (n=23)<br>Standard Medication Counseling. | Behavioral: Standard Medication Counseling (SMC)<br>* 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.<br>|
| Experimental: BI-MTM (n=23)<br>Brief Intervention Medication Therapy Management. | Behavioral: Brief Intervention Medication Therapy Management<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacy, Intervention, Medication Adherence