Clinical Decision Support to Improve System Naloxone Co-prescribing

NCT06271668 | Enrolling By Invitation

• 2 other identifiers: 23-2356R61DA057610
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert to facilitate the co-prescribing of naloxone, an opioid overdose reversal agent, with high-risk opioid prescriptions. Prescribing naloxone with opioids is a best practice described in the 2022 US Center for Disease Control and Prevention (CDC) guidelines on opioid prescribing. The CDS can improve quality of care delivered by improving compliance with the guideline defined best practices. The project will compare CDS alert facilitated co-prescribing of naloxone with high-risk opioid prescriptions vs usual care to evaluate the effectiveness of the CDS alert for improving naloxone prescribing. The patients are not assigned to an intervention and will be receiving any changes in care as part of their routine medical care, rather than a specific intervention that is distinct from their usual medical care. The researchers hypothesize that the CDS alert will be acceptable to providers while increasing naloxone co-prescribing which will reduce the number of opioid overdoses in subsequent 6 months.

Conditions

Harm Reduction; Opioid Overdose; Medication Abuse; Opioid Prescribing

Outcome Measures

Primary Outcomes (1)

• Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone

  The number of high-risk opioid encounters where a naloxone prescription was written with the opioid divided by the total number of encounters where a high-risk opioid prescription was written.

  18 months

Secondary Outcomes (3)

• Clinical decision support (CDS) acceptance rate

  18 months

• Subsequent opioid overdose/poisonings rates

  Six months after an encounter where the naloxone clinical decision support fired for the provider

• Naloxone dispensed rate

  In the 3 days after the naloxone prescription is written

Study Arms (2)

Clinical Decision Support (CDS): Naloxone Alert

Encounters where the naloxone clinical decision support (CDS) alert fired. CDS logic is programmed to fire alert when a provider places and order for a high-risk opioid analgesic prescription to a patient without an active naloxone prescription. High-risk prescription logic to trigger the Naloxone CDS: \[(NOT 1 AND (2 AND AT LEAST 1 OF (3, 4, 5, 6))) AND 7 AND NOT 8\] 1. ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER 2. OPIOID SCRIPT BEING PLACED CRITERIA 3. DAILY Milligram Morphine Equivalent (MME) \>=90 UNSIGNED ORDER 4. DAILY MME \>=90 EXISTING 5. DIAGNOSIS OF OPIOID USE DISORDER 6. DIAGNOSIS HISTORY OF OPIOID OVERDOSE 7. PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS 8. DISCHARGE TO HOSPICE

Other: Naloxone Co-prescribing Clinical Decision Support (CDS)

Usual Care

Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care.

Interventions

Naloxone Co-prescribing Clinical Decision Support (CDS) OTHER

Clinical decision support in the form of an EHR-integrated, provider facing alert suggesting (a) the opioid medication order is considered high risk for overdose and (b) to nudge providers to add a naloxone prescription to the opioid prescription to mitigate risk in the event of an overdose.

Clinical Decision Support (CDS): Naloxone Alert

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.

You may qualify if:

• Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented

You may not qualify if:

• Patients \<12 and \>89 year of age
• Cancer diagnosis
• Hospice care/palliative care
• Sickle cell disease diagnosis
• Patients who arrived in error
• Patients who were triaged to obstetrics

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction; Opiate Overdose

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Drug Overdose; Prescription Drug Misuse; Drug Misuse; Opioid-Related Disorders; Narcotic-Related Disorders

Study Officials

• Jason A Hoppe, DO

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: April 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
• Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.

Locations

US (1)