RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study

Study Overview
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Brief Summary
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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).

Detailed Description
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The purpose of this study is to integrate two pharmacy-focused educational interventions designed to increase pharmacy based naloxone (PBN) dispensing and improve opioid safety. The intervention is comprised of two successful demonstration research projects (RESPOND, PI: Hartung; MOON, PI: Green), which include online and one-on-one educational outreach (i.e. academic detailing) demonstrated to provide knowledge and training for pharmacists to identify and effectively engage with patients who may be at high-risk for an opioid overdose. This study tests the combined interventions' effectiveness at improving opioid safety engagement and naloxone-related outcomes in community pharmacies. The following primary specific aims will drive this research: For Aim 1: The research team and study pharmacy partners will work collaboratively to integrate MOON and RESPOND into MOON+, including the creation of a website to host intervention components. Feedback from community partners and pharmacy professional associations will be sought to finalize the MOON+ content and materials. For Aim 2: We will conduct a stepped wedge, cluster randomized design in 160 pharmacies throughout Oregon, Washington, Massachusetts, and New Hampshire. Implementation will occur across five waves, each of which will include a baseline survey, toolkit orientation session, academic detailing, an online course, and access to printed onsite materials (algorithm, checklists, stickers, posters). The targeted population is pharmacists and pharmacy managers in CVS pharmacies (MA and NH) and Albertsons Companies (OR and WA) across the study states and who volunteer to participate in the educational intervention. We will recruit 40 pharmacies per state, 160 pharmacies total, providing a sample of approximately 450 pharmacist participants. Each store will have a pharmacy champion (a pharmacist or pharmacy manager), who will be the point of contact for the intervention. Only pharmacies with a consenting pharmacy champion will be eligible for the study; pharmacists at those sites may opt to participate. Data collection will occur at baseline, 6-, and 12-month follow-up, using surveys (pharmacist-level), store dispensing data and daily faxed counts of naloxone encounters (store-level). Note that no identifiable health information about the patients will be collected in these forms, only basic counts and communication descriptors. The follow up surveys for pharmacists consist of brief questionnaires about the training, attitudes and perceptions of naloxone and naloxone dispensing, sale of syringes over the counter, and dispensing of buprenorphine. For Aim 3: We will use a mixed methods approach to identify facilitators and barriers (e.g. state-specific policies, store policies, region) to intervention implementation and effectiveness. Methods will include an environmental scan of extant laws and policies, fidelity checking, pharmacist focus groups (n=50), and interviews with patients who have received or would be eligible for receiving naloxone (n=28).

Official Title
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Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial

Conditions
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Pharmacies, Opioid Use, Patient Safety

Intervention / Treatment
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* Behavioral: MOON+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: none

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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Stepped-wedge cluster randomized design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOON+<br>MOON+ 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 | Behavioral: MOON+<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| baseline pharmacist self-reported changes | A 73 item questionnaire developed by the investigators will be used to collect data on knowledge, attitudes, perceived behavioral control, and self-efficacy toward dispensing naloxone. It has 5 sections: demographics (8 questions), experience within the pharmacy setting (18 questions), knowledge and experience with naloxone (19 questions), experience with overdose response (10 questions), overdose prevention and use of naloxone scenarios (18 questions). The questions use both multiple choice and likert scales formats. | baseline | 
| 6 month pharmacist self-reported changes | A 73 item questionnaire developed by the investigators will be used to collect data on knowledge, attitudes, perceived behavioral control, and self-efficacy toward dispensing naloxone. It has 5 sections: demographics (8 questions), experience within the pharmacy setting (18 questions), knowledge and experience with naloxone (19 questions), experience with overdose response (10 questions), overdose prevention and use of naloxone scenarios (18 questions). The questions use both multiple choice and likert scales formats. | six months post intervention | 
| 12 months pharmacist self-reported changes | A 73 item questionnaire developed by the investigators will be used to collect data on knowledge, attitudes, perceived behavioral control, and self-efficacy toward dispensing naloxone. It has 5 sections: demographics (8 questions), experience within the pharmacy setting (18 questions), knowledge and experience with naloxone (19 questions), experience with overdose response (10 questions), overdose prevention and use of naloxone scenarios (18 questions). The questions use both multiple choice and likert scales formats. | 12 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Naloxone, Community pharmacies, Academic detailing, MOON, MOON+, RESPOND