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

NCT03241771 | Completed DMC

• 2 other identifiers: CO-16-24051R01DA042059-01
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Opioid Abuse; Overdose; Risk Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Knowledge

  Within 1 month of study enrollment

• Naloxone Dispensings

  4 months

• Opioid dose

  4 months

• Drug Use Risk Behavior

  4 months

• Alcohol Use Risk Behavior

  4 months

Other Outcomes (2)

• Pain Intensity

  4 months

• Overdose

  4 months

Study Arms (2)

Naloxone Navigator 1.0

EXPERIMENTAL

Participants randomized to the Naloxone Navigator 1.0 arm will receive a link to the web-based resource. They will also receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).

Behavioral: Naloxone Navigator 1.0

Usual Care

NO INTERVENTION

Participants in the usual care arm will receive usual care from their health plan, pharmacy and physicians. As part of usual care, participants will have access to naloxone through standing orders (i.e., they can request it without a prescription under their usual pharmacy benefit).

Interventions

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.

Also known as: Naloxone Navigator (NN)

Naloxone Navigator 1.0

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Denver Health and Hospital Authority: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Denver Health

Denver, Colorado, 80204, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Drug Overdose; Risk-Taking

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Prescription Drug Misuse; Drug Misuse; 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: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: August 14, 2017
• Primary Completion: August 14, 2018
• Study Completion: August 31, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

US (1)