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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA042059 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ingrid Binswanger, MD | Kaiser Permanente | Principal Investigator |
| Jason Glanz, PhD | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Colorado | Denver | Colorado | 80231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39421268 | Derived | 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. |
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Investigators interested in using the data from this study must submit a written request. Requests must address regulatory and compliance requirements for data usage. Investigators must outline the necessary resources required to support their data request, including personnel and infrastructure. The original study team will evaluate each request based on scientific merit, ethical considerations, and alignment with the original study's objectives.
Deidentified survey and electronic health record (EHR) data will be shared with investigators upon approval of written request. Investigators are responsible for obtaining necessary approvals and adhering to relevant laws and regulations and will be required to sign a Data Use Agreement (DUA) outlining the terms and conditions of data usage. The data sharing period is limited to three years following the publication of the primary study. The Naloxone Navigator video is available upon request; please send an email to: jason.m.glanz@kp.org.
3 years following the publication of the primary study
See plan description
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 29, 2025 | |
| Reset | Sep 17, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 29, 2025 | Sep 17, 2025 |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| 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 |
| 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 |
| D001523 | Mental Disorders |
| D001519 | Behavior |