AzTrials
AzTrials

OverdoseNCT03337009

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

A study testing Naloxone Navigator (NN) in people with Overdose and Risk Behavior, run by Kaiser Permanente at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overdose, Risk Behavior
What is being tested?
Naloxone Navigator (NN)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,004 participants
Where
1 siteUnited States
Study dates
21 Dec 2017to 30 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Non-English speaking, hospice enrollment, do-not-resuscitate order, no internet access

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Kaiser Permanente Colorado

    Denver, Colorado, 80231

Other trials in United States

About this study

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.

Read the 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.

Being tested
Naloxone Navigator (NN)
Keywords
Opioid antagonist, Naloxone, Opioids, Web-based intervention
Medical subject headings
Drug Overdose, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naloxone Navigator (NN)Behavioural

    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.

Study groups in NCT03337009
Study groupRoleWhat they receive
Naloxone NavigatorExperimentalTargeted, 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.
Receives: Behavioral: Naloxone Navigator (NN)
Usual CareNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: Baseline to 12 months

  3. Patient reported naloxone pick-up

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2017
  2. Study start21 Dec 2017
  3. Primary completion30 Apr 2020
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,004 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03337009
Sponsor's protocol ID
CO-16-2405-01
Other IDs
1R01DA042059
Status last verified
May 2024
First submitted
16 Oct 2017
Last updated
20 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Glanz JM, Mueller SR, Narwaney KJ, Wagner N, Xu S, Kraus C, Wain K, Botts S, Binswanger IA. Effectiveness of direct patient outreach with a narrative naloxone and overdose prevention video to patients prescribed long-term opioid therapy in the USA: the Naloxone Navigator randomised clinical trial. BMJ Public Health. 2024 Jul;2(1):e000725. doi: 10.1136/bmjph-2023-000725. Epub 2024 Jul 8.

    PubMed 39421268

Questions about this trial

What is this clinical trial studying?

A study testing Naloxone Navigator (NN) in people with Overdose and Risk Behavior, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Opioid-Related Risk Behavior (time frame: Change from baseline to 4-6 months, and 8-12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03337009, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in