Preventing Opioid Overdose Deaths by Empowering Pharmacists to Dispense Naloxone
13 de octubre de 2021 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Alabama
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Auburn, Alabama, Estados Unidos, 36849
- Auburn University Harrison School of Pharmacy
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
The intervention group received naloxone resources + monthly reminders + educational webinar.
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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.
Otros nombres:
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.
Otros nombres:
Reminders consisted of monthly emails from investigators for the purpose of retaining study engagement.
Otros nombres:
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Sin intervención: Control
The control group received naloxone resources + monthly reminders + delayed educational webinar (after the 3-month study period).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in naloxone knowledge from baseline to immediately post-intervention and 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in perceived barriers from baseline to immediately post-intervention and 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in attitudes from baseline to immediately post-intervention and 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in confidence from baseline to immediately post-intervention and 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Change in intention from baseline to immediately post-intervention and 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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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).
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3 months: baseline (T1), immediately post-intervention (T2), and 3 months post-intervention (T3)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in number of naloxone prescriptions dispensed from baseline to 3 months post-intervention
Periodo de tiempo: 3 months: baseline (T1) and 3 months post-intervention (T3)
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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.
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3 months: baseline (T1) and 3 months post-intervention (T3)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lindsey Hohmann, PharmD, PhD, Auburn University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
18 de septiembre de 2018
Finalización primaria (Actual)
18 de septiembre de 2019
Finalización del estudio (Actual)
18 de septiembre de 2019
Fechas de registro del estudio
Enviado por primera vez
4 de octubre de 2021
Primero enviado que cumplió con los criterios de control de calidad
13 de octubre de 2021
Publicado por primera vez (Actual)
26 de octubre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
13 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R36HS026669-01A1 (Subvención/Contrato de la AHRQ de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
In order to protect confidentiality of participants, data will not be shared.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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