AzTrials
AzTrials

Opioid OverdoseNCT05093309

Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone

A study testing Educational Webinar, Resources and Reminders in people with Opioid Overdose, run by Auburn University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as change in number of naloxone prescriptions dispensed. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Opioid Overdose
What is being tested?
Educational Webinar, Resources and Reminders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteUnited States
Study dates
18 Sep 2018to 18 Sep 2019
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

  • Registered pharmacists.
  • Employed at least 30 hours per week at a community pharmacy.
  • Employed at a community pharmacy located in one of 20 Alabama priority counties with the highest opioid overdose mortality rates.

Who cannot join

  • Multiple pharmacists from the same pharmacy site.
  • Members of the stakeholder panel (from the formative phase of the study).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Auburn University Harrison School of Pharmacy

    Auburn, Alabama, 36849

Other trials in United States

About this study

Objectives: The purpose of this study was to assess the impact of the Empowering Community Pharmacists program on pharmacists' knowledge, perceived barriers, attitudes, confidence, and intentions regarding naloxone services implementation, as well as change in number of naloxone prescriptions dispensed.

Methods: A 3-month pragmatic randomized controlled trial was conducted in 2018-2019. Alabama community pharmacists were recruited by email, phone, fax, and mailed postcards and randomized to intervention (monthly resources/reminders + educational webinar) or control (monthly resources/reminders + delayed educational webinar). Outcome measures were assessed via online surveys at baseline (T1), immediately post-intervention (T2), and 3-months post-intervention (T3), including: naloxone knowledge (percent correct); perceived barriers, attitudes, and confidence regarding naloxone services implementation (7-point Likert-type scale, 1=strongly disagree to 7=strongly agree); and number of naloxone prescriptions dispensed. Mean differences between control and intervention groups from T1-T3 were assessed using two-way mixed ANOVA and adjusted analyses were conducted using generalized estimating equations (GEE) with negative binomial distribution (alpha=0.05).

Conditions
Opioid Overdose
Being tested
Educational Webinar, Resources, Reminders
Keywords
naloxone, community pharmacy, implementation
Medical subject headings
Opiate Overdose

What participants receive

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

  • Educational WebinarBehavioural

    Also called Empowering Community Pharmacists Webinar

    At month 1 of the study period, the educational webinar was presented by expert speakers and consisted of 3 modules: 1) naloxone basics; 2) naloxone service implementation strategies; and 3) naloxone recommendation communication strategies. Participants were mailed naloxone nasal spray and auto-injector training devices prior to attending the online webinar so that they could follow along during demonstrations.

  • ResourcesBehavioural

    Also called Flyers

    After completing the baseline survey, both control and intervention groups were provided with a basic publicly available flyer about naloxone dosage forms in order to ensure all participants could provide adequate patient care.

  • RemindersBehavioural

    Also called Nudge

    Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.

Study groups in NCT05093309
Study groupRoleWhat they receive
InterventionExperimentalThe intervention group received naloxone resources + monthly reminders + educational webinar.
Receives: Behavioral: Educational Webinar; Behavioral: Resources; Behavioral: Reminders
ControlNo interventionThe control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).

What is being measured

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

  1. Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention

    Knowledge about naloxone was measured via online survey. Knowledge was measured as percent correct on a 7-item index adapted from Williams' (2013) Opioid Overdose Knowledge Scale (OOKS).

    Measured: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

  2. Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention

    Perceived barriers to adoption/implementation of pharmacy-based naloxone services was measured via online survey. Barriers (20-items) were measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

    Measured: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

  3. Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention

    Attitudes regarding pharmacy-based naloxone services was measured via online survey. Attitudes (15-items) were measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

    Measured: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

  4. Change in confidence from baseline to immediately post-intervention and 3 months post-intervention

    Confidence in performing naloxone dispensing behaviors was measured via online survey. Confidence (10-items) was measured using 7-point Likert-type scales (1=strongly disagree, 7=strongly agree) and informed by Nielsen et al (2016) and Williams' (2013) Opioid Overdose Attitude Scale (OOAS).

    Measured: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

  5. Change in intention from baseline to immediately post-intervention and 3 months post-intervention

    Intention to dispense naloxone or perform naloxone services in the next three months was measured via online survey. The 5-item intention construct was measured using a 7-point Likert-type scale from 1=strongly disagree to 7=strongly agree and informed by an existing intention measure by Urmie et al (2007).

    Measured: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)

Secondary outcomes (1)

  1. Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention

    The number of naloxone prescriptions dispensed over 3 months before and after the intervention was assessed via self-report at T1 and T3. Participants utilized national drug codes (NDCs) within their pharmacy dispensing software to identify naloxone dispensing information.

    Measured: 3 months: baseline (T1) and 3 months post-intervention (T3)

Timeline

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

  1. First posted26 Oct 2021
  2. Study start18 Sep 2018
  3. Primary completion18 Sep 2019
  4. Study completion18 Sep 2019

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05093309
Sponsor's protocol ID
R36HS026669-01A1
Status last verified
Oct 2021
First submitted
4 Oct 2021
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In order to protect confidentiality of participants, data will not be shared.

Publications

  • Hohmann LA, Fox BI, Garza KB, Wang CH, Correia C, Curran GM, Westrick SC. Impact of a Multicomponent Educational Intervention on Community Pharmacy-Based Naloxone Services Implementation: A Pragmatic Randomized Controlled Trial. Ann Pharmacother. 2023 Jun;57(6):677-695. doi: 10.1177/10600280221120405. Epub 2022 Sep 1.

    PubMed 36047381

Questions about this trial

What is this clinical trial studying?

A study testing Educational Webinar, Resources and Reminders in people with Opioid Overdose, run by Auburn University at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention (time frame: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)). The study lists 5 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 NCT05093309, which also lists 1 linked publication.

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 26 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in