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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Risk Behavior; Overdose
• Intervention / Treatment: Behavioral: Naloxone Navigator (NN)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1004
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80231
      • Kaiser Permanente Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Exclusion Criteria:

• Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Opioid-Related Risk Behavior	Risk behavior will be assessed using the Opioid-Related Behaviors in Treatment (ORBIT) scale. The ORBIT is a scale used to identify recent risk behavior among patients receiving chronic opioid therapy. Scores on the single scale range from 0-40, with lower values representing less risk behavior.	Change from baseline to 4-6 months, and 8-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overdose and Naloxone 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. The investigators have adapted it to be specific to prescription opioids. The modified-OOKS is scored on a scale of 0-28, with higher values representing greater knowledge about overdose and naloxone.	Baseline post-intervention and sustained effects at 4-6 and 8-12 months
Rate of Naloxone Dispensings	Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting.	Baseline to 12 months
Patient reported naloxone pick-up	Patient surveys will be used to identify naloxone dispensings in the outpatient setting.	Baseline to 12 months
Change in opioid dose	Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose.	Baseline to 12 months
Change in Drug Use Risk Behavior	Drug Use Risk Behavior will be assessed using question 2 of the validated National Institutes on Drug Abuse-Modified Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scale version 2.0. Scores on the single scale range from 0-60, with lower values representing less drug use risk behavior.	Change from baseline to 4-6 months, and 8-12 months
Change in Hazardous Drinking and Alcohol Use Disorders	Alcohol Use Risk Behavior will be assessed using the validated Alcohol Use Disorders Identification Test--Consumption (AUDIT-C) scale. AUDIT-C is a screener used to identify patients with alcohol use disorders or hazardous drinking behavior. The AUDIT-C is scored on a scale of 0-12. The higher the score, the more likely it is that the patient's drinking is affecting his or her safety.	Change from baseline to 4-6 months, and 8-12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Pain intensity will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS Scale v1.0 - Pain Intensity 3a. The PROMIS Pain Intensity instrument is scored on a scale of 3-15. A higher score represents greater pain intensity.	Change from baseline to 4-6 months, and 8-12 months
Rate of Opioid Overdose	Overdoses will be assessed using self-report, electronic health record data and death records.	Baseline to 12 months
Rate of Aberrant Urine Toxicology Screens	Urine toxicology screen results found in laboratory databases will be used to measure opioid medication diversion and drug use.	Baseline to 12 months

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ingrid Binswanger, MD, Kaiser Permanente; Principal Investigator: Jason Glanz, PhD, Kaiser Permanente

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Web-based intervention; Opioids; Naloxone; Opioid antagonist
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Substance-Related Disorders; Drug Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: CO-16-2405-01; 1R01DA042059 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No