The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy

Browse trials for

• Drug Overdose 104
• Risk-Taking 136

Keywords

• Opioid antagonist
• Naloxone
• Opioids
• Web-based intervention

Drug Overdose

104 studies on the registry are indexed under Drug Overdose; 22 are open to participants now.

This study's enrollment of 1,004 is above the median of 124 across 76 interventional studies indexed under Drug Overdose.

Lead sponsor

Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Study arms

• Experimental
  Naloxone Navigator

  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.

  Behavioral: Naloxone Navigator (NN)

• No intervention
  Usual Care

  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.

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.

Primary outcomes

1. 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.

   Time frame: Change from baseline to 4-6 months, and 8-12 months

Secondary outcomes

1. 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.

   Time frame: Baseline post-intervention and sustained effects at 4-6 and 8-12 months

2. Rate of Naloxone Dispensings

   Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting.

   Time frame: Baseline to 12 months

3. Patient reported naloxone pick-up

   Patient surveys will be used to identify naloxone dispensings in the outpatient setting.

   Time frame: Baseline to 12 months

4. Change in opioid dose

   Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose.

   Time frame: Baseline to 12 months

5. 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.

   Time frame: Change from baseline to 4-6 months, and 8-12 months

6. 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.

   Time frame: Change from baseline to 4-6 months, and 8-12 months

Other outcomes

1. 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.

   Time frame: Change from baseline to 4-6 months, and 8-12 months

2. Rate of Opioid Overdose

   Overdoses will be assessed using self-report, electronic health record data and death records.

   Time frame: Baseline to 12 months

3. 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.

   Time frame: Baseline to 12 months

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

Time frame: 3 years following the publication of the primary study

Access criteria: See plan description