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

Primary Purpose

Overdose, Risk Behavior

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Naloxone Navigator (NN)
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overdose focused on measuring Opioid antagonist, Naloxone, Opioids, Web-based intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Naloxone Navigator

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Rate of Naloxone Dispensings
Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting.
Patient reported naloxone pick-up
Patient surveys will be used to identify naloxone dispensings in the outpatient setting.
Change in opioid dose
Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose.
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.
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.

Full Information

First Posted
October 16, 2017
Last Updated
August 23, 2023
Sponsor
Kaiser Permanente
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03337009
Brief Title
The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
Official Title
The Impact of a Web-Based Naloxone Intervention Under Standing Orders to Patients Prescribed Chronic Opioid Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overdose, Risk Behavior
Keywords
Opioid antagonist, Naloxone, Opioids, Web-based intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naloxone Navigator
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Naloxone Navigator (NN)
Intervention Description
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 Outcome Measure Information:
Title
Change in Opioid-Related Risk Behavior
Description
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 Outcome Measure Information:
Title
Overdose and Naloxone Knowledge
Description
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
Title
Rate of Naloxone Dispensings
Description
Pharmacy or insurance claims databases will be used to identify naloxone dispensings in the outpatient setting.
Time Frame
Baseline to 12 months
Title
Patient reported naloxone pick-up
Description
Patient surveys will be used to identify naloxone dispensings in the outpatient setting.
Time Frame
Baseline to 12 months
Title
Change in opioid dose
Description
Using pharmacy or insurance claims data, the investigators will calculate changes in the milligrams morphine equivalent dose.
Time Frame
Baseline to 12 months
Title
Change in Drug Use Risk Behavior
Description
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
Title
Change in Hazardous Drinking and Alcohol Use Disorders
Description
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 Pre-specified Outcome Measures:
Title
Change in Pain Intensity
Description
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
Title
Rate of Opioid Overdose
Description
Overdoses will be assessed using self-report, electronic health record data and death records.
Time Frame
Baseline to 12 months
Title
Rate of Aberrant Urine Toxicology Screens
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingrid Binswanger, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Glanz, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80231
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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