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

Not Applicable

Active, not recruiting

• Conditions: Risk Behavior; Overdose
• Interventions: Behavioral: Naloxone Navigator (NN)

• Registration Number: NCT03337009
• Lead Sponsor: Kaiser Permanente

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-16
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Study Start: 2017-12-21
• Primary Completion: 2020-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1004

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Naloxone Navigator	Naloxone Navigator (NN)	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.

Primary Outcome Measures

Name	Time	Method
Change in Opioid-Related Risk Behavior	Change from baseline to 4-6 months, and 8-12 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient reported naloxone pick-up	Baseline to 12 months	Patient surveys will be used to identify naloxone dispensings in the outpatient setting.
Overdose and Naloxone Knowledge	Baseline post-intervention and sustained effects at 4-6 and 8-12 months	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.
Change in Hazardous Drinking and Alcohol Use Disorders	Change from baseline to 4-6 months, and 8-12 months	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.
Rate of Naloxone Dispensings	Baseline to 12 months	Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting.
Change in opioid dose	Baseline to 12 months	Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose.
Change in Drug Use Risk Behavior	Change from baseline to 4-6 months, and 8-12 months	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.

Trial Locations

Locations (1)

Kaiser Permanente Colorado; 🇺🇸 Denver, Colorado, United States