Clinical trial NCT03337100: The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy
Official title: The Impact of Co-Dispensing Naloxone to Patients Prescribed Chronic Opioid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overdose
Risk Behavior
Keywords: Opioids
Naloxone
Co-dispensing
Cluster randomized trial
Opioid antagonist
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Denver Health and Hospital Authority
name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Opioid-Related Risk Behavior
timeFrame: Change from baseline to 4-6 months and 8-10 months
Secondary outcomes:
measure: Overdose and Naloxone Knowledge
timeFrame: Change from baseline to 4-6 months, and 8-10 months
measure: Rate of Naloxone Dispensings
timeFrame: Baseline up to 2.5 years
measure: Patient reported naloxone pick-up
timeFrame: Baseline up to 10 months
measure: Changes in opioid dose
timeFrame: Baseline up to 2.5 years
measure: Change in Drug Use Risk Behavior
timeFrame: Change from baseline to 4-6 months and 8-10 months
measure: Change in Hazardous Drinking or Alcohol Use Disorders
timeFrame: Change from baseline to 4-6 months and 8-10 months
Other outcomes:
measure: Change in Pain Intensity
timeFrame: Change from baseline to 4-6 months and 8-10 months
measure: Rate of Opioid Overdose
timeFrame: Baseline up to 2.5 years
measure: Rate of Aberrant Urine Toxicology Screens
timeFrame: Baseline up to 2.5 years
Locations:
city: Denver
country: United States
facility: Denver Health
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Jason Glanz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Ingrid Binswanger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Binswanger IA, Rinehart D, Mueller SR, Narwaney KJ, Stowell M, Wagner N, Xu S, Hanratty R, Blum J, McVaney K, Glanz JM. Naloxone Co-Dispensing with Opioids: a Cluster Randomized Pragmatic Trial. J Gen Intern Med. 2022 Aug;37(11):2624-2633. doi: 10.1007/s11606-021-07356-6. Epub 2022 Feb 7.