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RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study

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ClinicalTrials.gov Identifier: NCT03545321
Recruitment Status : Recruiting
First Posted : June 4, 2018
Last Update Posted : March 26, 2021
Sponsor:
Collaborators:
Comagine Health
Oregon Health and Science University
University of Rhode Island
University of Washington
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brandeis University

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).

Condition or disease Intervention/treatment Phase
Pharmacies Opioid Use Patient Safety Behavioral: MOON+ Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Stepped-wedge cluster randomized design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial
Actual Study Start Date : July 9, 2019
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MOON+
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+
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




Primary Outcome Measures :
  1. 6 month change in naloxone distribution rates from study pharmacies [ Time Frame: baseline, six months post intervention ]
    Naloxone fill data from study pharmacies

  2. 12 month change in naloxone distribution rates from study pharmacies [ Time Frame: baseline, 12 months post intervention ]
    Naloxone fill data from study pharmacies

  3. 6 month change in naloxone-related patient engagement in the pharmacy [ Time Frame: baseline, six months post intervention ]
    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

  4. 12 month change in naloxone-related patient engagement in the pharmacy [ Time Frame: baseline, 12 months post intervention ]
    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


Secondary Outcome Measures :
  1. baseline pharmacist self-reported changes [ Time Frame: baseline ]
    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.

  2. 6 month pharmacist self-reported changes [ Time Frame: six months post intervention ]
    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.

  3. 12 months pharmacist self-reported changes [ Time Frame: 12 months post intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03545321


Contacts
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Contact: Traci C Green, PhD, MSc (781) 736-2609 tracigreen@brandeis.edu
Contact: Jesse S Boggis, MPH 781-736-2607 jboggis@brandeis.edu

Locations
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United States, Massachusetts
Brandeis University Recruiting
Waltham, Massachusetts, United States, 02453
Contact: Traci Green, PhD, MSc    781-736-2609    tracigreen@brandeis.edu   
Principal Investigator: Traci C Green, PhD, MSc         
United States, Oregon
Comagine Health Recruiting
Portland, Oregon, United States, 97232
Contact: Gillian Leichtling    503-382-3928    gleichtling@comagine.org   
Oregon Health and Sciences University Recruiting
Portland, Oregon, United States, 97239
Contact: Daniel Hartung, PharmD, MPH    503-494-4720    hartungd@ohsu.edu   
Principal Investigator: Daniel Hartung, PharmD, MPH         
United States, Rhode Island
University of Rhode Island Recruiting
Kingston, Rhode Island, United States, 02881-1966
Contact: Jeffrey Bratberg, PharmD    401-419-6303    jefbratberg@uri.edu   
Principal Investigator: Jeffrey Bratberg, PharmD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Anthony Floyd, PhD    206-616-7382    asfloyd@uw.edu   
Principal Investigator: Anthony Floyd, PhD         
Sponsors and Collaborators
Brandeis University
Comagine Health
Oregon Health and Science University
University of Rhode Island
University of Washington
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Traci C Green, PhD, MSc Brandeis University
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Responsible Party: Brandeis University
ClinicalTrials.gov Identifier: NCT03545321    
Other Study ID Numbers: H-37685
R01DA045745 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be shared with other researchers upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brandeis University:
Naloxone
Community pharmacies
Academic detailing
MOON
MOON+
RESPOND