Nalox-Comm: Naloxone Communication Training for Pharmacists

Naloxone Clinical Trial

— Nalox-Comm  

Official title:

Addressing the Opioid Epidemic Through Community Pharmacy Engagement: Randomized Controlled Trial (Aim 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04677387
• Other study ID #: 20-2192
• Secondary ID: R34DA046598
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• currently work at a pharmacy that stocks naloxone;
• currently work at a rural community pharmacy;
• 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.

Related Conditions & MeSH terms

• Naloxone

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill (Asheville campus)	Asheville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (16)

Alte D, Weitschies W, Ritter CA. Evaluation of consultation in community pharmacies with mystery shoppers. Ann Pharmacother. 2007 Jun;41(6):1023-30. doi: 10.1345/aph.1H565. Epub 2007 May 22. — View Citation

Bjornsdottir I, Granas AG, Bradley A, Norris P. A systematic review of the use of simulated patient methodology in pharmacy practice research from 2006 to 2016. Int J Pharm Pract. 2020 Feb;28(1):13-25. doi: 10.1111/ijpp.12570. Epub 2019 Aug 9. — View Citation

Browne T, Priester MA, Clone S, Iachini A, DeHart D, Hock R. Barriers and Facilitators to Substance Use Treatment in the Rural South: A Qualitative Study. J Rural Health. 2016 Winter;32(1):92-101. doi: 10.1111/jrh.12129. Epub 2015 Jul 15. — View Citation

Diggle P, Heagerty P, Liang K-Y, Zeger S. Analysis of longitudinal data. Oxford University Press; 2002.

Freeman PR, Goodin A, Troske S, Strahl A, Fallin A, Green TC. Pharmacists' role in opioid overdose: Kentucky pharmacists' willingness to participate in naloxone dispensing. J Am Pharm Assoc (2003). 2017 Mar-Apr;57(2S):S28-S33. doi: 10.1016/j.japh.2016.12.064. Epub 2017 Jan 28. — View Citation

Gamm L, Stone S, Pittman S. Mental health and mental disorders-A rural challenge: A literature review. Rural healthy people. 2010;1:97-114.

Hagemeier NE, Murawski MM, Lopez NC, Alamian A, Pack RP. Theoretical exploration of Tennessee community pharmacists' perceptions regarding opioid pain reliever abuse communication. Res Social Adm Pharm. 2014 May-Jun;10(3):562-75. doi: 10.1016/j.sapharm.2013.07.004. Epub 2013 Aug 24. — View Citation

Liekens S, Vandael E, Roter D, Larson S, Smits T, Laekeman G, Foulon V. Impact of training on pharmacists' counseling of patients starting antidepressant therapy. Patient Educ Couns. 2014 Jan;94(1):110-5. doi: 10.1016/j.pec.2013.09.023. Epub 2013 Oct 12. — View Citation

Madden JM, Quick JD, Ross-Degnan D, Kafle KK. Undercover careseekers: simulated clients in the study of health provider behavior in developing countries. Soc Sci Med. 1997 Nov;45(10):1465-82. doi: 10.1016/s0277-9536(97)00076-2. — View Citation

Mueller SR, Koester S, Glanz JM, Gardner EM, Binswanger IA. Attitudes Toward Naloxone Prescribing in Clinical Settings: A Qualitative Study of Patients Prescribed High Dose Opioids for Chronic Non-Cancer Pain. J Gen Intern Med. 2017 Mar;32(3):277-283. doi: 10.1007/s11606-016-3895-8. Epub 2016 Oct 31. — View Citation

Nielsen S, Menon N, Larney S, Farrell M, Degenhardt L. Community pharmacist knowledge, attitudes and confidence regarding naloxone for overdose reversal. Addiction. 2016 Dec;111(12):2177-2186. doi: 10.1111/add.13517. Epub 2016 Aug 16. — View Citation

Strahan R, Gerbasi K. Short, homogenous version of the Marlowe-Crowne social desirability scale. Journal of Clinical Psychology. 1972;28(191):193.

Thornton JD, Lyvers E, Scott VGG, Dwibedi N. Pharmacists' readiness to provide naloxone in community pharmacies in West Virginia. J Am Pharm Assoc (2003). 2017 Mar-Apr;57(2S):S12-S18.e4. doi: 10.1016/j.japh.2016.12.070. Epub 2017 Feb 2. — View Citation

Weiss MC, Booth A, Jones B, Ramjeet S, Wong E. Use of simulated patients to assess the clinical and communication skills of community pharmacists. Pharm World Sci. 2010 Jun;32(3):353-61. doi: 10.1007/s11096-010-9375-z. Epub 2010 Mar 18. — View Citation

Williams AV, Strang J, Marsden J. Development of Opioid Overdose Knowledge (OOKS) and Attitudes (OOAS) Scales for take-home naloxone training evaluation. Drug Alcohol Depend. 2013 Sep 1;132(1-2):383-6. doi: 10.1016/j.drugalcdep.2013.02.007. Epub 2013 Feb 28. — View Citation

Wilson JD, Spicyn N, Matson P, Alvanzo A, Feldman L. Internal medicine resident knowledge, attitudes, and barriers to naloxone prescription in hospital and clinic settings. Subst Abus. 2016 Jul-Sep;37(3):480-487. doi: 10.1080/08897077.2016.1142921. Epub 2016 Jan 28. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the number of times Naloxone is dispensed over a 6 month period	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.	3-month period before and 3-month period after pharmacist completes intervention training
Secondary	Change from Baseline in Willingness to Dispense Naloxone Score at 3 months	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.	Baseline, 3-months post-intervention
Secondary	Change from Baseline in Naloxone Counselling Self-Efficacy Score at 3 months	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.	Baseline, 3-months post-intervention
Secondary	Change from Baseline in Pharmacist Quality of Non-verbal Communication score up to 1 month post-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.	Baseline, 1-month period after pharmacist completes intervention training

External Links

•   Parker T. Rural-Urban Continuum Codes. 2013.