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Completed

NCT Number: NCT03241771

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

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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Key information

Conditions

Opioid Abuse Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Overdose Prescription Drug Misuse Risk Behavior Risk-Taking Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Denver Health

Denver, Colorado, 80204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naloxone Navigator 1.0

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.

Other names: Naloxone Navigator (NN)

Primary outcomes

  1. Risk Behavior

    Time frame: 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 outcomes

  1. Patient Knowledge

    Time frame: 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.

  2. Naloxone Dispensings

    Time frame: 4 months

    Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.

  3. Opioid dose

    Time frame: 4 months

    We will calculate changes in the milligrams morphine equivalent dose

  4. Drug Use Risk Behavior

    Time frame: 4 months

    Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.

  5. Alcohol Use Risk Behavior

    Time frame: 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

Other outcomes

  1. Pain Intensity

    Time frame: 4 months

    Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Pain Intensity - Short Form instrument measures pain intensity over time

  2. Overdose

    Time frame: 4 months

    Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Denver Health and Hospital Authority
  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2022
First posted
Aug 7, 2017
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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