The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2018 |
| Start Date: | November 27, 2017 |
| End Date: | April 30, 2022 |
| Contact: | Shane R Mueller, MSW |
| Email: | shane.mueller@kp.org |
| Phone: | 303-614-1360 |
In the setting of naloxone standing orders, this study will assess if co-dispensing naloxone
with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors,
increases naloxone uptake, and increases knowledge about overdose and naloxone.
with opioids to patients prescribed chronic opioid therapy changes opioid risk behaviors,
increases naloxone uptake, and increases knowledge about overdose and naloxone.
This is a pragmatic, pharmacy-based, cluster randomized controlled trial of a naloxone
co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6)
will be randomized to the order in which they are encouraged to implement a naloxone
co-dispensing program for patients prescribed chronic opioid therapy. The intent of this
program is to provide patients prescribed chronic opioid therapy naloxone for potential
opioid overdose reversal under the terms of a standing order. Participants prescribed chronic
opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk
surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors
(target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and
naloxone, substance use, and pain intensity. Patients who use randomized pharmacies
(anticipated n=550 patients) will also be followed in the electronic health record for
secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology
results, and overdose events.
co-dispensing program for adults prescribed chronic opioid therapy. Pharmacies (target N=6)
will be randomized to the order in which they are encouraged to implement a naloxone
co-dispensing program for patients prescribed chronic opioid therapy. The intent of this
program is to provide patients prescribed chronic opioid therapy naloxone for potential
opioid overdose reversal under the terms of a standing order. Participants prescribed chronic
opioid therapy who use randomized pharmacies will be recruited to receive knowledge and risk
surveys at baseline and over the follow-up. The primary outcome is opioid risk behaviors
(target enrollment is 200 patients). Secondary outcomes include knowledge about overdose and
naloxone, substance use, and pain intensity. Patients who use randomized pharmacies
(anticipated n=550 patients) will also be followed in the electronic health record for
secondary outcomes: naloxone dispensings, changes in opioid dose, aberrant urine toxicology
results, and overdose events.
Study Population:
- Eligible pharmacies
- Patients prescribed chronic opioid therapy
Inclusion Criteria for pharmacies:
- Stock naloxone for outpatient dispensing.
- Pharmacy leadership willing to provide naloxone under a co-dispensing protocol.
- Pharmacy leadership willing to be randomized to order of implementation.
- Have or can implement a naloxone standing order.
Exclusion Criteria for pharmacies:
• None
Inclusion Criteria for patients:
- Prescribed chronic opioid therapy and meet criteria for the pharmacy co-dispensing
protocol
- Receive medications at participating pharmacies
- Have a health plan which covers the formulation of naloxone available at the pharmacy
they received their opioid prescriptions from.
- (for surveys)18 years of age or greater
Exclusion Criteria:
• (for surveys) Non-English speaking, hospice enrollment, do-not-resuscitate order
We found this trial at
1
site
Denver, Colorado 80204
Principal Investigator: Deborah Rinehart, PhD
Phone: 303-602-2743
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