Opioid Abuse, Overdose, Risk Behavior
Conditions
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
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.
Interventions
BEHAVIORALNaloxone 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.
Sponsors
Denver Health and Hospital Authority
National Institute on Drug Abuse (NIDA)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Outcome results
None listed