RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study
Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial
2 other identifiers
interventional
450
1 country
5
Brief Summary
This multi-site study will test the efficacy of an intervention to train and equip pharmacists to provide naloxone, an overdose antidote, to patients using prescribed and illicit opioids, to improve opioid safety and prevent opioid-involved adverse events. The study will carry out a stepped-wedge, cluster randomized trial implemented over five waves, within two chain community pharmacies across four states with varying pharmacy-based naloxone distribution laws: Oregon, Washington, Massachusetts, and New Hampshire. Our specific study aims are to: 1) integrate two successful demonstration research projects into one cohesive educational program (MOON+), 2) evaluate the effectiveness of MOON + on naloxone-related outcomes, and 3) use mixed methods to further explore the impact and implementation of MOON+ and associated factors (e.g., state policy, store policy, region).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedStudy Start
First participant enrolled
July 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedMarch 2, 2022
March 1, 2022
3.3 years
May 8, 2018
March 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
6 month change in naloxone distribution rates from study pharmacies
Naloxone fill data from study pharmacies
baseline, six months post intervention
12 month change in naloxone distribution rates from study pharmacies
Naloxone fill data from study pharmacies
baseline, 12 months post intervention
6 month change in naloxone-related patient engagement in the pharmacy
counts of naloxone-related conversations between pharmacy staff and patients and friends/family of opioid users will be recorded in a MOON+ log book by pharmacy staff
baseline, six months post intervention
12 month change in naloxone-related patient engagement in the pharmacy
counts of naloxone-related conversations between pharmacy staff and patients and friends/family of opioid users will be recorded in a MOON+ log book by pharmacy staff
baseline, 12 months post intervention
Secondary Outcomes (3)
baseline pharmacist self-reported changes
baseline
6 month pharmacist self-reported changes
six months post intervention
12 months pharmacist self-reported changes
12 months post intervention
Study Arms (1)
MOON+
EXPERIMENTALMOON+ includes pharmacist online training on opioid safety and naloxone provision, academic detailing of the pharmacy, materials for use at the pharmacy, standardized overdose response safety protocols, and reminder tools for training reinforcement
Interventions
MOON+ is an intervention to support the pharmacy and pharmacist to improve opioid safety and naloxone provision. Materials include educational trainings, materials for use with pharmacists, information for patients, and materials for standardizing overdose safety at the pharmacy
Eligibility Criteria
You may qualify if:
- English speaking, age 18 years or older, a pharmacist or pharmacy manager employed half time or more by CVS Pharmacy in Massachusetts or New Hampshire or by Albertsons Companies in Washington or Oregon
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brandeis Universitylead
- Comagine Healthcollaborator
- Oregon Health and Science Universitycollaborator
- University of Rhode Islandcollaborator
- University of Washingtoncollaborator
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (5)
Brandeis University
Waltham, Massachusetts, 02453, United States
Comagine Health
Portland, Oregon, 97232, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
University of Rhode Island
Kingston, Rhode Island, 02881-1966, United States
University of Washington
Seattle, Washington, 98105, United States
Related Publications (2)
Blough MJ, Rocha A, Bratberg J, Silcox J, Bolivar D, Floyd AS, Gray M, Green TC. The Cost of Safe Injection: Insights on Nonprescription Syringe Price Variability From Systematic Secret Shopping. Subst Use Addctn J. 2024 Apr;45(2):201-210. doi: 10.1177/29767342231217831. Epub 2024 Jan 4.
PMID: 38258818DERIVEDGreen TC, Silcox J, Bolivar D, Gray M, Floyd AS, Irwin AN, Hansen RN, Hartung DM, Bratberg J. Pharmacy staff-reported adaptations to naloxone provision and over-the-counter (OTC) syringe sales during the COVID-19 pandemic: Experiences across multiple states and 2 pharmacy chains. J Am Pharm Assoc (2003). 2024 Jan-Feb;64(1):71-78. doi: 10.1016/j.japh.2023.10.014. Epub 2023 Oct 18.
PMID: 37863398DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Traci C Green, PhD, MSc
Brandeis University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2018
First Posted
June 4, 2018
Study Start
July 9, 2019
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
March 2, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Data will be shared with other researchers upon request.