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

Risk Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241771
• Other study ID #: CO-16-2405
• Secondary ID: 1R01DA042059-01
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: August 31, 2022
• Est. primary completion date: August 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid-Related Disorders
• Overdose
• Risk Behavior

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Denver Health	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Denver Health and Hospital Authority, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Intensity	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	4 months
Other	Overdose	Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.	4 months
Primary	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	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
Secondary	Naloxone Dispensings	Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.	4 months
Secondary	Opioid dose	We will calculate changes in the milligrams morphine equivalent dose	4 months
Secondary	Drug Use Risk Behavior	Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.	4 months
Secondary	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