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Nalox-Comm: Naloxone Communication Training for Pharmacists (Nalox-Comm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04677387
Recruitment Status : Enrolling by invitation
First Posted : December 21, 2020
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Description
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Brief Summary:
This is a pilot Randomized Controlled Trial (RCT) in which 120 pharmacists will be randomized to an experimental or control group and data on naloxone dispensing and secondary outcomes will be collected over the course of the RCT.

Condition or disease Intervention/treatment Phase
Naloxone Behavioral: Nalox-comm Training Module Behavioral: Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists Not Applicable

Detailed Description:
This is a prospective pilot RCT that will evaluate the impact of naloxone communication training (Nalox-Comm) on 120 pharmacists' naloxone dispensing behaviors (primary outcome). Data will be collected at baseline, immediately after training is completed, and at 3-month follow up. Data sources include pharmacy records (for naloxone dispensing), simulated patient observations (to rate quality of communication), and survey data (for self-reports of knowledge and self-efficacy).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Prescribe to Prevent Naloxone Training Module
This a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists.
 Behavioral: Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists
A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.
Experimental: Nalox-Comm
This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.
 Behavioral: Nalox-comm Training Module
The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.


Outcome Measures
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Primary Outcome Measures :
  1. Change in the number of times Naloxone is dispensed over a 6 month period [ Time Frame: 3-month period before and 3-month period after pharmacist completes intervention training ]
    Pharmacy records will indicate the number of times each pharmacy dispensed naloxone over the RCT period. These data will be aggregated into the total number of naloxone fills in the 3 months pre-intervention and the 3 months postintervention.


Secondary Outcome Measures :
  1. Change from Baseline in Willingness to Dispense Naloxone Score at 3 months [ Time Frame: Baseline, 3-months post-intervention ]
    An online survey including 6 self-reported Likert-scale items will assess pharmacists' willingness to dispense naloxone. Four items from the Nielsen naloxone attitudes scale and 2 items from the Wilson Hospital-based Overdose Prevention and Education (HOPE) measure will be used. These items assess pharmacists' willingness to engage in naloxone counseling activities, including educating patients to recognize overdose and administer naloxone, proactively identify individuals for naloxone dispensation, and dispense naloxone. Response options will range from 1= "not at all willing" to 4= "very willing." Items will be averaged to create a mean willingness score (range = 1-4), with higher scores indicating more willingness to dispense naloxone. Mean willingness scores will be calculated at baseline and 3 months post-intervention.

  2. Change from Baseline in Naloxone Counselling Self-Efficacy Score at 3 months [ Time Frame: Baseline, 3-months post-intervention ]
    An online survey including 6 self-reported Likert-scale items will assess pharmacists' self-efficacy to counsel about naloxone. Four items from the Nielsen naloxone attitudes scale and 2 items from the Wilson HOPE measure will be used. Pharmacists will be asked to rate their confidence to engage in various naloxone communication tasks including: engage in naloxone counseling when the pharmacy is busy and discuss naloxone in a way that does not offend customers. Response options will range from 1= "not at all confident" to 4= "very confident." Items will be averaged to create a mean self-efficacy score (range = 1-4), with higher scores indicating greater self-efficacy to dispense naloxone. Mean self-efficacy scores will be calculated at baseline and 3 months post-intervention.

  3. Change from Baseline in Pharmacist Quality of Non-verbal Communication score up to 1 month post-training [ Time Frame: Baseline, 1-month period after pharmacist completes intervention training ]
    Simulated patients (SPs) will call pharmacists and use a validated observation guide that has been adapted for use for telephone interactions to rate the pharmacists' quality of non-verbal communication. The guide includes 4 items (i.e., explained things clearly, listened carefully, showed respect, and spent enough time with the SP) measured on a 5-point scale (1= not at all satisfied, 2= partly satisfied, 3= satisfied, 4= more than satisfied, 5= very satisfied). Higher scores (range = 1-5) indicate a more positive evaluation of the interaction.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All Ingles pharmacist stock naloxone, and all 120 pharmacists at the participating pharmacies will be eligible because they:

  • work at one of the 60 rural Ingles Pharmacies in which the intervention is being conducted;
  • are at least 18 years of age; and
  • speak English.

Exclusion Criteria:

  • Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677387


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill (Asheville campus)
Asheville, North Carolina, United States, 28804
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Delesha Carpenter, PhD, MSPH UNC Eshelman School of Pharmacy
More Information
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Additional Information:

Publications:
Gamm L, Stone S, Pittman S. Mental health and mental disorders-A rural challenge: A literature review. Rural healthy people. 2010;1:97-114.
Watson MC, Norris P, Granas A. A systematic review of the use of simulated patients and pharmacy practice research. International Journal of Pharmacy Practice. 2006;14(2):83-93.
Strahan R, Gerbasi K. Short, homogenous version of the Marlowe-Crowne social desirability scale. Journal of Clinical Psychology. 1972;28(191):193.
Diggle P, Heagerty P, Liang K-Y, Zeger S. Analysis of longitudinal data. Oxford University Press; 2002.

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04677387    
Other Study ID Numbers: 20-2192
R34DA046598 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 9-36 months following publication
Access Criteria: The investigator who proposes to use the data must have IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
community pharmacy
communication
Additional relevant MeSH terms:
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Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents