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

Study Overview
=================
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.

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

Conditions
-----------------
Opioid Abuse, Overdose, Risk Behavior

Intervention / Treatment
-----------------
* Behavioral: Naloxone Navigator 1.0


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naloxone Navigator 1.0<br>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). | Behavioral: Naloxone Navigator 1.0<br>* Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.<br>* Other names: Naloxone Navigator (NN);|
| No Intervention: Usual Care<br>Participants in the usual care arm will 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). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk Behavior | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Knowledge | 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. | Within 1 month of study enrollment | 
| Naloxone Dispensings | Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting. | 4 months | 
| Opioid dose | We will calculate changes in the milligrams morphine equivalent dose | 4 months | 
| Drug Use Risk Behavior | Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale. | 4 months | 
| Alcohol Use Risk Behavior | 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 | 4 months |