Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders

Not Applicable

Completed

• Conditions: Overdose; Opioid Abuse; Risk Behavior
• Interventions: Behavioral: Naloxone Navigator 1.0

• Registration Number: NCT03241771
• Lead Sponsor: Kaiser Permanente

Brief Summary

In the setting of naloxone standing orders, this study will assess if direct outreach with a web-based "Naloxone Navigator 1.0" to patients prescribed chronic opioid therapy (COT) changes opioid risk behaviors, increases naloxone uptake, and increases knowledge about overdose and naloxone

Detailed Description

This is a randomized study of a web-based naloxone educational resource (Naloxone Navigator 1.0) for adults prescribed chronic opioid therapy. This study will be conducted under new naloxone standing order legislation passed in Colorado. The Naloxone Navigator 1.0 will provide online training on how to recognize an opioid overdose and respond using naloxone. There will be two arms: one will receive a link to the Naloxone Navigator 1.0 and the other will receive usual care (no link). Outcomes will include opioid risk behavior, overdose and naloxone knowledge, naloxone dispensings, and overdose rates.

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-07
• Study Start: 2017-08-14
• Primary Completion: 2018-08-14
• Study Completion: 2022-08-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• 18 years of age or greater prescribed chronic opioid therapy

Exclusion Criteria

• Non-English speaking, hospice enrollment, do-not-resuscitate order, receipt of naloxone in the last 12 months, no internet access, not planning to continue to receive care in the same setting for the next 4 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naloxone Navigator 1.0	Naloxone Navigator 1.0	Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).

Primary Outcome Measures

Name	Time	Method
Risk Behavior	4 months	Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a brief scale used to identify recent risk behavior among patients receiving chronic opioid therapy.

Secondary Outcome Measures

Name	Time	Method
Patient Knowledge	Within 1 month of study enrollment	Patient knowledge of overdose and naloxone will be measured using survey items adapted from the Opioid Overdose Knowledge Scale (OOKS). The OOKS is a scale measuring knowledge of overdose risks, warning signs, steps to address the overdose and appropriate use of naloxone.
Naloxone Dispensings	4 months	Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.
Drug Use Risk Behavior	4 months	Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.
Alcohol Use Risk Behavior	4 months	Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C Lite) scale. AUDIT-C Lite is a brief screener used to identify patients with alcohol use disorders or hazardous drinking behavior
Opioid dose	4 months	We will calculate changes in the milligrams morphine equivalent dose

Trial Locations

Locations (1)

Denver Health; 🇺🇸 Denver, Colorado, United States