Clinical trial NCT03337009: The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
Official title: The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overdose
Risk Behavior
Keywords: Opioid antagonist
Naloxone
Opioids
Web-based intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-11-08
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the setting of naloxone standing orders, this study will assess the impact of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. Outcomes are changes in opioid risk behaviors, naloxone uptake, and knowledge about overdose and naloxone.

Detailed description: This is a patient level randomized study of a targeted, web-based overdose prevention and naloxone intervention for patients prescribed chronic opioid therapy. This study will be conducted in a health system which has implemented naloxone standing orders. Adults prescribed chronic opioid therapy will be identified in the electronic health record, outreached, and recruited for participation. Once enrolled, participants will be randomized to usual care or the intervention. The web-based intervention is an animated video which provides education on what is an opioid overdose, how to prevent and recognize an opioid overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under standing orders. Participants will be given knowledge and risk surveys over the follow-up. The primary outcome is opioid risk behavior. Secondary outcomes include knowledge about overdose and naloxone, substance use, and pain intensity. Patients will also be followed in the electronic health record for naloxone dispensings, changes in opioid dose, aberrant urine toxicology results, and overdose events.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater
* Prescribed chronic opioid therapy
* Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.

Exclusion Criteria:

* Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access

Primary outcomes:
measure: Change in Opioid-Related Risk Behavior
timeFrame: Change from baseline to 4-6 months, and 8-12 months
Secondary outcomes:
measure: Overdose and Naloxone Knowledge
timeFrame: Baseline post-intervention and sustained effects at 4-6 and 8-12 months
measure: Rate of Naloxone Dispensings
timeFrame: Baseline to 12 months
measure: Patient reported naloxone pick-up
timeFrame: Baseline to 12 months
measure: Change in opioid dose
timeFrame: Baseline to 12 months
measure: Change in Drug Use Risk Behavior
timeFrame: Change from baseline to 4-6 months, and 8-12 months
measure: Change in Hazardous Drinking and Alcohol Use Disorders
timeFrame: Change from baseline to 4-6 months, and 8-12 months
Other outcomes:
measure: Change in Pain Intensity
timeFrame: Change from baseline to 4-6 months, and 8-12 months
measure: Rate of Opioid Overdose
timeFrame: Baseline to 12 months
measure: Rate of Aberrant Urine Toxicology Screens
timeFrame: Baseline to 12 months
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Ingrid Binswanger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Jason Glanz, PhD
role: PRINCIPAL_INVESTIGATOR
References: