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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1004 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-21

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Overdose Risk Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Naloxone Navigator

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.

Group Type EXPERIMENTAL

Naloxone Navigator (NN)

Intervention Type BEHAVIORAL

Patients prescribed chronic opioid therapy will be identified and recruited to enroll in the study. Patients randomized to receive the web-based animated video (Naloxone Navigator) will be sent a link to the video after enrollment. The web-based, animated video provides education on what is an opioid overdose, how to prevent it, how to recognize an overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under a standing order.

Usual Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Naloxone Navigator (NN)

Patients prescribed chronic opioid therapy will be identified and recruited to enroll in the study. Patients randomized to receive the web-based animated video (Naloxone Navigator) will be sent a link to the video after enrollment. The web-based, animated video provides education on what is an opioid overdose, how to prevent it, how to recognize an overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under a standing order.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.