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

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ClinicalTrials.gov Identifier: NCT03241771
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kaiser Permanente

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

Condition or disease Intervention/treatment Phase
Opioid Abuse Overdose Risk Behavior Behavioral: Naloxone Navigator 1.0 Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : July 31, 2018
Estimated Study Completion Date : July 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Naloxone Navigator 1.0
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
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.
Other Name: Naloxone Navigator (NN)

No Intervention: Usual Care
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).



Primary Outcome Measures :
  1. Risk Behavior [ Time Frame: 4 months ]
    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.


Secondary Outcome Measures :
  1. Patient Knowledge [ Time Frame: Within 1 month of study enrollment ]
    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.

  2. Naloxone Dispensings [ Time Frame: 4 months ]
    Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.

  3. Opioid dose [ Time Frame: 4 months ]
    We will calculate changes in the milligrams morphine equivalent dose

  4. Drug Use Risk Behavior [ Time Frame: 4 months ]
    Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.

  5. Alcohol Use Risk Behavior [ Time Frame: 4 months ]
    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


Other Outcome Measures:
  1. Pain Intensity [ Time Frame: 4 months ]
    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

  2. Overdose [ Time Frame: 4 months ]
    Fatal and nonfatal overdoses will be assessed using International Classification of Disease (ICD)-10 codes in the electronic health record data and death records.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241771


Locations
United States, Colorado
Denver Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Kaiser Permanente
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Ingrid Binswanger, MD Kaiser Permanente
Principal Investigator: Jason Glanz, PhD Kaiser Permanente

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03241771     History of Changes
Other Study ID Numbers: CO-16-2405
1R01DA042059-01 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents