Impact of Direct Outreach to Expand Access to Naloxone in the Context of Standing Orders
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 Names:
|
| 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). |
Outcome Measures
Primary Outcome Measures
- Risk Behavior [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
- Patient Knowledge [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.
- Naloxone Dispensings [4 months]
Electronic health records and pharmacy databases will be used to identify naloxone dispensings in the outpatient setting.
- Opioid dose [4 months]
We will calculate changes in the milligrams morphine equivalent dose
- Drug Use Risk Behavior [4 months]
Drug Use Risk Behavior will be assessed using the validated National Institutes on Drug Abuse-Modified (ASSIST) scale.
- Alcohol Use Risk Behavior [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
- Pain Intensity [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
- Overdose [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CO-16-2405
- 1R01DA042059-01