Nalox-Comm: Naloxone Communication Training for Pharmacists

NCT04677387 | Completed Results DMC

• 2 other identifiers: 20-2192R34DA046598
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Naloxone

Keywords

community pharmacy; communication

Outcome Measures

Primary Outcomes (1)

• Change in Naloxone Dispensing Rate Over a 6-month Period

  Pharmacy records indicated the number of times each pharmacy dispensed naloxone and opioid prescriptions over the RCT period. These data were aggregated into the total number of naloxone and opioid prescriptions dispensed in the 3 months pre-intervention and the 3 months post-intervention. The change in naloxone dispensing rates was measured by comparing pharmacy records of the number of naloxone products dispensed in the three months prior to study participation to the number of naloxone products dispensed in the three months after study completion. The rate was defined as the number of naloxone products dispensed divided by the number of opioid prescriptions dispensed in each 3-month period.

  3-month period before intervention and 3-month follow-up dispensing data

Secondary Outcomes (3)

• Mean Willingness to Dispense Naloxone Score

  up to 3-month Follow-up Survey

• Mean Naloxone Counselling Self-Efficacy Score

  up to 3-month Follow-up Survey

• Mean Pharmacist Quality of Non-verbal Communication Score

  up to 1-month post-training

Study Arms (2)

Prescribe to Prevent Naloxone Training Module

PLACEBO COMPARATOR

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

Nalox-Comm

EXPERIMENTAL

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

Interventions

Nalox-comm Training Module BEHAVIORAL

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.

Nalox-Comm

Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists BEHAVIORAL

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.

Prescribe to Prevent Naloxone Training Module

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-staff pharmacists such as pharmacy "floaters" or fill-in pharmacists will not be eligible to participate.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill (Asheville campus)

Asheville, North Carolina, 28804, United States

Location

Related Publications (16)

• 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.

  PMID: 28163027 BACKGROUND

• 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.

  PMID: 23981913 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 26184098 BACKGROUND

• 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.

  PMID: 28139459 BACKGROUND

• 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.

  PMID: 27798775 BACKGROUND

• 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.

  PMID: 27367125 BACKGROUND

• 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.

  PMID: 24169022 BACKGROUND

• 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.

  PMID: 17519295 BACKGROUND

• 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.

  PMID: 20238164 BACKGROUND

• 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.

  PMID: 9351137 BACKGROUND

• 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.

  PMID: 31397533 BACKGROUND

• 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.

  PMID: 26820604 BACKGROUND

• 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.

  PMID: 23453260 BACKGROUND

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

  BACKGROUND

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

  BACKGROUND

Related Links

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

MeSH Terms

Conditions

Communication

Interventions

Pharmacists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Delesha Carpenter, PhD, MSPH
• Organization: University of North Carollina at Chapel Hill

dmcarpenter@unc.edu

828-250-3916

Study Officials

• Delesha Carpenter, PhD, MSPH

  UNC Eshelman School of Pharmacy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: July 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, 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.

Locations

US (1)