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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

325 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2022-08-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Opioid Abuse Overdose Risk Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Naloxone Navigator 1.0

Intervention Type BEHAVIORAL

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.

Usual Care

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Naloxone Navigator 1.0

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Naloxone Navigator (NN)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No