Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
13 oktober 2021 uppdaterad av: Lindsey Hohmann, Auburn University
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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
55
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Alabama
-
Auburn, Alabama, Förenta staterna, 36849
- Auburn University Harrison School of Pharmacy
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Multiple pharmacists from the same pharmacy site.
- Members of the stakeholder panel (from the formative phase of the study).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intervention
The intervention group received naloxone resources + monthly reminders + educational 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.
Andra namn:
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.
Andra namn:
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Andra namn:
|
|
Inget ingripande: Control
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
Tidsram: 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).
|
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
Tidsram: 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).
|
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
Tidsram: 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).
|
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
Tidsram: 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).
|
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
Tidsram: 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).
|
3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
Tidsram: 3 months: baseline (T1) and 3 months post-intervention (T3)
|
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.
|
3 months: baseline (T1) and 3 months post-intervention (T3)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Lindsey Hohmann, PharmD, PhD, Auburn University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 september 2018
Primärt slutförande (Faktisk)
18 september 2019
Avslutad studie (Faktisk)
18 september 2019
Studieregistreringsdatum
Först inskickad
4 oktober 2021
Först inskickad som uppfyllde QC-kriterierna
13 oktober 2021
Första postat (Faktisk)
26 oktober 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 oktober 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 oktober 2021
Senast verifierad
1 oktober 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R36HS026669-01A1 (U.S.A. AHRQ-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
In order to protect confidentiality of participants, data will not be shared.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .