Clinical trial NCT03149718: Community Pharmacists and Opioid Misuse
Official title: Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Misuse
Keywords: Pharmacy
Intervention
Medication Adherence
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-05-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention feasibility
timeFrame: Month 21 of Study
measure: Intervention acceptability
timeFrame: Month 21 of Study
Secondary outcomes:
measure: Opioid Misuse
timeFrame: Month 21 of Study
measure: Patient Self-Management
timeFrame: Month 21 of Study
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Falk Pharmacy
state: Pennsylvania
city: Somerset
country: United States
facility: Medicine Shoppe
state: Pennsylvania
Study officials:
affiliation: University of Utah
name: Gerald Cochran, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: