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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA042059-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Denver Health and Hospital Authority | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient 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. | Within 1 month of study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | 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 | 4 months |
| Overdose |
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 |
|---|---|---|---|---|---|---|
| Denver Health | Denver | Colorado | 80204 | United States |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D062787 | Drug Overdose |
| D012309 | Risk-Taking |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Naloxone Dispensings |
Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting. |
| 4 months |
| Opioid dose | We will calculate changes in the milligrams morphine equivalent dose | 4 months |
| Drug Use Risk Behavior | Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale. | 4 months |
| Alcohol Use Risk Behavior | 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 | 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.
| 4 months |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D001519 | Behavior |