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

NCT03337009 | Active Not Recruiting DMC

• 2 other identifiers: CO-16-2405-011R01DA042059
• Study Type: interventional
• Target: 1,004
• Locations: 1 country
• Sites: 1

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.

Conditions

Overdose; Risk Behavior

Keywords

Opioid antagonist; Naloxone; Opioids; Web-based intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overdose and Naloxone Knowledge

  Baseline post-intervention and sustained effects at 4-6 and 8-12 months

• Rate of Naloxone Dispensings

  Baseline to 12 months

• Patient reported naloxone pick-up

  Baseline to 12 months

• Change in opioid dose

  Baseline to 12 months

• Change in Drug Use Risk Behavior

  Change from baseline to 4-6 months, and 8-12 months

Other Outcomes (3)

• Change in Pain Intensity

  Change from baseline to 4-6 months, and 8-12 months

• Rate of Opioid Overdose

  Baseline to 12 months

• Rate of Aberrant Urine Toxicology Screens

  Baseline to 12 months

Study Arms (2)

Naloxone Navigator

EXPERIMENTAL

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)

Usual Care

NO INTERVENTION

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.

Interventions

Naloxone Navigator (NN) 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.

Naloxone Navigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Kaiser Permanente Colorado

Denver, Colorado, 80231, United States

Location

Related Publications (1)

• Glanz JM, Mueller SR, Narwaney KJ, Wagner N, Xu S, Kraus C, Wain K, Botts S, Binswanger IA. Effectiveness of direct patient outreach with a narrative naloxone and overdose prevention video to patients prescribed long-term opioid therapy in the USA: the Naloxone Navigator randomised clinical trial. BMJ Public Health. 2024 Jul;2(1):e000725. doi: 10.1136/bmjph-2023-000725. Epub 2024 Jul 8.

  PMID: 39421268 DERIVED

MeSH Terms

Conditions

Drug Overdose; Risk-Taking

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Ingrid Binswanger, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Jason Glanz, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 8, 2017
• Study Start: December 21, 2017
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 3 years following the publication of the primary study
• Access Criteria: See plan description

Locations

US (1)