Overdose, Risk Behavior
Conditions
Keywords
Opioid antagonist, Naloxone, Opioids, Web-based intervention
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALNaloxone Navigator (NN)
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.
Sponsors
National Institute on Drug Abuse (NIDA)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
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 * Have a health plan which covers the formulation of naloxone available at the pharmacy they received their opioid prescriptions from.
Exclusion criteria
* Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Opioid-Related Risk Behavior | Change from baseline to 4-6 months, and 8-12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported naloxone pick-up | Baseline to 12 months | Patient surveys will be used to identify naloxone dispensings in the outpatient setting. |
| Change in opioid dose | Baseline to 12 months | Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose. |
| Change in Drug Use Risk Behavior | Change from baseline to 4-6 months, and 8-12 months | 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 in Hazardous Drinking and Alcohol Use Disorders | Change from baseline to 4-6 months, and 8-12 months | 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. |
| Overdose and Naloxone Knowledge | Baseline post-intervention and sustained effects at 4-6 and 8-12 months | 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. |
| Rate of Naloxone Dispensings | Baseline to 12 months | Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Aberrant Urine Toxicology Screens | Baseline to 12 months | Urine toxicology screen results found in laboratory databases will be used to measure opioid medication diversion and drug use. |
| Change in Pain Intensity | Change from baseline to 4-6 months, and 8-12 months | 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. |
| Rate of Opioid Overdose | Baseline to 12 months | Overdoses will be assessed using self-report, electronic health record data and death records. |
Countries
United States
Outcome results
None listed