Naloxone
Conditions
Keywords
community pharmacy, communication
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.
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).
Interventions
BEHAVIORALNalox-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.
BEHAVIORALPrescribe 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.
Sponsors
National Institute on Drug Abuse (NIDA)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Naloxone Dispensing Rate Over a 6-month Period | 3-month period before intervention and 3-month follow-up dispensing data | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Willingness to Dispense Naloxone Score | up to 3-month Follow-up Survey | An online survey including 6 self-reported Likert-scale items will assess pharmacists' willingness to dispense naloxone. 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 were averaged to create a mean willingness score (range = 1-4), with higher scores indicating more willingness to dispense naloxone. |
| Mean Naloxone Counselling Self-Efficacy Score | up to 3-month Follow-up Survey | An online survey including 6 self-reported Likert-scale items assessed pharmacists' self-efficacy to counsel about naloxone. Pharmacists rated 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 ranged from 1= not at all confident to 4= very confident. Items were averaged to create a mean self-efficacy score (range = 1-4), with higher scores indicating greater self-efficacy to dispense naloxone. |
| Mean Pharmacist Quality of Non-verbal Communication Score | up to 1-month post-training | Simulated patients (SPs) called pharmacists and used a validated observation guide that has been adapted for use for telephone interactions to rate the pharmacists' quality of non-verbal communication. The guide included 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prescribe to Prevent Naloxone Training Module This is a 55-minute online module that covers basic information about naloxone that is relevant to community pharmacists.
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. | 25 |
| Nalox-Comm This is a newly developed 30-60 minute online module focused on teaching pharmacists how to overcome naloxone communication barriers.
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. | 23 |
| Total | 48 |
Baseline characteristics
| Characteristic | Prescribe to Prevent Naloxone Training Module | Nalox-Comm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 22 Participants | 46 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 23 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 21 Participants | 43 Participants |
| Region of Enrollment United States | 25 Participants | 23 Participants | 48 Participants |
| Sex/Gender, Customized Sex/Gender Female | 16 Participants | 11 Participants | 27 Participants |
| Sex/Gender, Customized Sex/Gender Male | 8 Participants | 12 Participants | 20 Participants |
| Sex/Gender, Customized Sex/Gender Prefer not to answer | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 0 / 25 | 0 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 |
Outcome results
Primary
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.
Time frame: 3-month period before intervention and 3-month follow-up dispensing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prescribe to Prevent Naloxone Training Module | Change in Naloxone Dispensing Rate Over a 6-month Period | .0073 number of naloxone products dispensed | Standard Deviation 0.015 |
| Nalox-Comm | Change in Naloxone Dispensing Rate Over a 6-month Period | .0041 number of naloxone products dispensed | Standard Deviation 0.0139 |
p-value: 0.473Regression, Linear
Secondary
Mean Naloxone Counselling Self-Efficacy Score
An online survey including 6 self-reported Likert-scale items assessed pharmacists' self-efficacy to counsel about naloxone. Pharmacists rated 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 ranged from 1= not at all confident to 4= very confident. Items were averaged to create a mean self-efficacy score (range = 1-4), with higher scores indicating greater self-efficacy to dispense naloxone.
Time frame: up to 3-month Follow-up Survey
Population: Only participants who completed Baseline and 3-month Follow-up Survey were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prescribe to Prevent Naloxone Training Module | Mean Naloxone Counselling Self-Efficacy Score | Baseline Survey | 3.08 score on a scale | Standard Error 0.012 |
| Prescribe to Prevent Naloxone Training Module | Mean Naloxone Counselling Self-Efficacy Score | Immediate Post-training Survey | 3.19 score on a scale | Standard Error 0.116 |
| Prescribe to Prevent Naloxone Training Module | Mean Naloxone Counselling Self-Efficacy Score | 3-month Follow-up Survey | 3.28 score on a scale | Standard Error 0.105 |
| Nalox-Comm | Mean Naloxone Counselling Self-Efficacy Score | Baseline Survey | 2.74 score on a scale | Standard Error 0.112 |
| Nalox-Comm | Mean Naloxone Counselling Self-Efficacy Score | Immediate Post-training Survey | 3.4 score on a scale | Standard Error 0.107 |
| Nalox-Comm | Mean Naloxone Counselling Self-Efficacy Score | 3-month Follow-up Survey | 3.51 score on a scale | Standard Error 0.098 |
p-value: 0.002Regression, Linear
Secondary
Mean Pharmacist Quality of Non-verbal Communication Score
Simulated patients (SPs) called pharmacists and used a validated observation guide that has been adapted for use for telephone interactions to rate the pharmacists' quality of non-verbal communication. The guide included 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.
Time frame: up to 1-month post-training
Population: All available data are reported and include pharmacists whose communication behavior was possible to be observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prescribe to Prevent Naloxone Training Module | Mean Pharmacist Quality of Non-verbal Communication Score | baseline | 3.31 score on a scale | Standard Error 0.141 |
| Prescribe to Prevent Naloxone Training Module | Mean Pharmacist Quality of Non-verbal Communication Score | 1-month follow-up | 3.62 score on a scale | Standard Error 0.182 |
| Nalox-Comm | Mean Pharmacist Quality of Non-verbal Communication Score | baseline | 3.5 score on a scale | Standard Error 0.149 |
| Nalox-Comm | Mean Pharmacist Quality of Non-verbal Communication Score | 1-month follow-up | 4.11 score on a scale | Standard Error 0.123 |
p-value: 0.169Regression, Linear
Secondary
Mean Willingness to Dispense Naloxone Score
An online survey including 6 self-reported Likert-scale items will assess pharmacists' willingness to dispense naloxone. 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 were averaged to create a mean willingness score (range = 1-4), with higher scores indicating more willingness to dispense naloxone.
Time frame: up to 3-month Follow-up Survey
Population: Only participants who completed Baseline and 3-month Follow-up Survey were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prescribe to Prevent Naloxone Training Module | Mean Willingness to Dispense Naloxone Score | Baseline Survey | 3.72 score on a scale | Standard Error 0.07 |
| Prescribe to Prevent Naloxone Training Module | Mean Willingness to Dispense Naloxone Score | Immediate Post-training Survey | 3.64 score on a scale | Standard Error 0.096 |
| Prescribe to Prevent Naloxone Training Module | Mean Willingness to Dispense Naloxone Score | 3-month Follow-up Survey | 3.47 score on a scale | Standard Error 0.14 |
| Nalox-Comm | Mean Willingness to Dispense Naloxone Score | Baseline Survey | 3.57 score on a scale | Standard Error 0.117 |
| Nalox-Comm | Mean Willingness to Dispense Naloxone Score | Immediate Post-training Survey | 3.84 score on a scale | Standard Error 0.07 |
| Nalox-Comm | Mean Willingness to Dispense Naloxone Score | 3-month Follow-up Survey | 3.69 score on a scale | Standard Error 0.107 |
p-value: 0.007Regression, Linear