Community Pharmacists and Opioid Misuse

Opioid Misuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03149718
• Other study ID #: PRO17010410
• Secondary ID: R21DA043735
• Status: Completed
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: October 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 1, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Misuse

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Falk Pharmacy	Pittsburgh	Pennsylvania
United States	Medicine Shoppe	Somerset	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility	Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.	Month 21 of Study
Primary	Intervention acceptability	Intervention acceptability will be demonstrated though qualitative interviews.	Month 21 of Study
Secondary	Opioid Misuse	Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).	Month 21 of Study
Secondary	Patient Self-Management	Patient self-management activation misuse than will be captured by the Patient Activation Measure.	Month 21 of Study