- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03545321
RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study
Intervention to Increase Naloxone Engagement and Distribution in Community Pharmacies: A Four-State Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Waltham, Massachusetts, United States, 02453
- Brandeis University
-
-
Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Sciences University
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Portland, Oregon, United States, 97232
- Comagine Health
-
-
Rhode Island
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Kingston, Rhode Island, United States, 02881-1966
- University of Rhode Island
-
-
Washington
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Seattle, Washington, United States, 98105
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 month change in naloxone distribution rates from study pharmacies
Time Frame: baseline, six months post intervention
|
Naloxone fill data from study pharmacies
|
baseline, six months post intervention
|
12 month change in naloxone distribution rates from study pharmacies
Time Frame: baseline, 12 months post intervention
|
Naloxone fill data from study pharmacies
|
baseline, 12 months post intervention
|
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
|
baseline, six months post intervention
|
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
|
baseline, 12 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline
|
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.
|
six months post intervention
|
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.
|
12 months post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Traci C Green, PhD, MSc, Brandeis University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H-37685
- R01DA045745 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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