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PharmaciesNCT03545321

RESPOND TO PREVENT: Stepwise Pharmacy Naloxone Study

A study testing MOON+ in people with Pharmacies and Opioid Use, run by Brandeis University at 5 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pharmacies, Opioid Use, Patient Safety
What is being tested?
MOON+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
5 sitesUnited States
Study dates
9 Jul 2019to Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • none

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Rhode Island

    Kingston, Rhode Island, 02881-1966

  • Comagine Health

    Portland, Oregon, 97232

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • University of Washington

    Seattle, Washington, 98105

  • Brandeis University

    Waltham, Massachusetts, 02453

Other trials in United States

About this study

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

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).

Read the 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).

Being tested
MOON+
Keywords
Naloxone, Community pharmacies, Academic detailing, MOON, MOON+, RESPOND

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOON+Behavioural

    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

Study groups in NCT03545321
Study groupRoleWhat they receive
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
Receives: Behavioral: MOON+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 month change in naloxone distribution rates from study pharmacies

    Naloxone fill data from study pharmacies

    Measured: baseline, six months post intervention

  2. 12 month change in naloxone distribution rates from study pharmacies

    Naloxone fill data from study pharmacies

    Measured: baseline, 12 months post intervention

  3. 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

    Measured: baseline, six months post intervention

  4. 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

    Measured: baseline, 12 months post intervention

Secondary outcomes (3)

  1. 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.

    Measured: baseline

  2. 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.

    Measured: six months post intervention

  3. 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.

    Measured: 12 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2018
  2. Study start9 Jul 2019
  3. Primary completionNov 2022 (estimated)
  4. Study completionNov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Stepped-wedge cluster randomized design
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03545321
Sponsor's protocol ID
H-37685
Other IDs
R01DA045745
Status last verified
Mar 2022
First submitted
8 May 2018
Last updated
2 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be shared with other researchers upon request.

Publications

  • 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.

    PubMed 38258818

  • Green 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.

    PubMed 37863398

Questions about this trial

What is this clinical trial studying?

A study testing MOON+ in people with Pharmacies and Opioid Use, run by Brandeis University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 month change in naloxone distribution rates from study pharmacies (time frame: baseline, six months post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03545321, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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