The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy

Kaiser Permanente

Status: Active, not recruiting

Conditions: Risk Behavior; Overdose

Treatments: Behavioral: Naloxone Navigator (NN)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03337009

1R01DA042059 (U.S. NIH Grant/Contract)

CO-16-2405-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,004 participants in 2 patient groups

Naloxone Navigator

Experimental group

Description:

Targeted, web-based animated video (Naloxone Navigator \[NN\]): This arm is a web-based intervention targeted to patients receiving chronic opioid therapy identified in the electronic health record. Participants in this arm have access to naloxone under standing orders from the pharmacy or with a prescription from their providers.

Treatment:

Behavioral: Naloxone Navigator (NN)

Usual Care

No Intervention group

Description:

Participants in the usual care arm will receive usual care from their health plan, pharmacy and clinicians. As part of usual care, participants can access naloxone through physician prescription or standing orders.