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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group received naloxone resources + monthly reminders + educational webinar. Receives: Behavioral: Educational Webinar; Behavioral: Resources; Behavioral: Reminders |
| Control | No intervention | The 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.
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)
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)
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)
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)
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)
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.
- First posted26 Oct 2021
- Study start18 Sep 2018
- Primary completion18 Sep 2019
- Study completion18 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Lindsey Hohmann, Auburn University
- Investigators
- Lindsey Hohmann, PharmD, PhD, Principal investigator, Auburn University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
- ClinicalTrials.gov ID
- NCT05093309
- Acronym / sponsor ID
- R36HS026669-01A1
- Conditions
- Opioid Overdose
- Keywords
- naloxone, community pharmacy, implementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational Webinar, Behavioral: Resources, Behavioral: RemindersThe intervention group received naloxone resources + monthly reminders + educational webinar. |
| Control | No intervention | –The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Multiple pharmacists from the same pharmacy site.
- Members of the stakeholder panel (from the formative phase of the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational WebinarAlso: Empowering Community Pharmacists WebinarAt 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. | Behavioural | Intervention |
| ResourcesAlso: FlyersAfter 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. | Behavioural | Intervention |
| RemindersAlso: NudgeReminders consisted of monthly emails from investigators for the purpose of retaining study engagement. | Behavioural | Intervention |
Primary outcome
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)
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).
Change in perceived barriers 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)
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).
Change in attitudes 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)
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).
Change in confidence 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)
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).
Change in intention 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)
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).
1 secondary outcome
Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
Time frame: 3 months: baseline (T1) and 3 months post-intervention (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 36047381Hohmann 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.
- Individual participant dataSharing planned: No. In order to protect confidentiality of participants, data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsey Hohmann, PharmD, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
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.