Community Pharmacists and Opioid Misuse
Primary Purpose
Opioid Misuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention Medication Therapy Management
Standard Medication Counseling (SMC)
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Misuse focused on measuring Pharmacy, Intervention, Medication Adherence
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
Sites / Locations
- Falk Pharmacy
- Medicine Shoppe
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SMC (n=23)
BI-MTM (n=23)
Arm Description
Standard Medication Counseling.
Brief Intervention Medication Therapy Management.
Outcomes
Primary Outcome Measures
Intervention feasibility
Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.
Intervention acceptability
Intervention acceptability will be demonstrated though qualitative interviews.
Secondary Outcome Measures
Opioid Misuse
Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).
Patient Self-Management
Patient self-management activation misuse than will be captured by the Patient Activation Measure.
Full Information
NCT ID
NCT03149718
First Posted
May 5, 2017
Last Updated
October 11, 2019
Sponsor
University of Utah
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03149718
Brief Title
Community Pharmacists and Opioid Misuse
Official Title
Prescription Opioid Misuse: Pharmacist-Delivered Intervention at Point of Service
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Misuse
Keywords
Pharmacy, Intervention, Medication Adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMC (n=23)
Arm Type
Active Comparator
Arm Description
Standard Medication Counseling.
Arm Title
BI-MTM (n=23)
Arm Type
Experimental
Arm Description
Brief Intervention Medication Therapy Management.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention Medication Therapy Management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Medication Counseling (SMC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intervention feasibility
Description
Intervention feasibility will be established through delivery of all BI-MTM components to 85% of BI-MTM recipients.
Time Frame
Month 21 of Study
Title
Intervention acceptability
Description
Intervention acceptability will be demonstrated though qualitative interviews.
Time Frame
Month 21 of Study
Secondary Outcome Measure Information:
Title
Opioid Misuse
Description
Opioid misuse will be demonstrated by the Prescription Opioid Misuse Index (POMI).
Time Frame
Month 21 of Study
Title
Patient Self-Management
Description
Patient self-management activation misuse than will be captured by the Patient Activation Measure.
Time Frame
Month 21 of Study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Cochran, Ph.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Falk Pharmacy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medicine Shoppe
City
Somerset
State/Province
Pennsylvania
ZIP/Postal Code
15501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Community Pharmacists and Opioid Misuse
We'll reach out to this number within 24 hrs