Clinical Decision Support to Improve System Naloxone Co-prescribing

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Medication Abuse Behavior Chemically-Induced Disorders Drug Misuse Drug Overdose Harm Reduction Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid Overdose Opioid Prescribing Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

12 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

About this study

Clinical decision support tools help clinicians make treatment decisions based on routinely collected data and offer a promising strategy to implement evidence-based practices for safe and effective pain management. This project will use clinical decision support tools embedded into electronic health records to help healthcare providers make treatment decisions that align with opioid prescribing guidelines from the Centers for Disease Control and Prevention (CDC). The project will also use information from prescription drug monitoring programs, insurance claims, and mortality data to evaluate patient outcomes. This research will evaluate how prescribing practices that align with CDC guidelines affect patient outcomes and whether clinical decision support tools provide an advantage over standard care practices for pain management.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 18 months

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.

Secondary outcomes

Clinical decision support (CDS) acceptance rate

Time frame: 18 months

The number of times providers accepted the Clinical decision support (CDS) suggestion and co-prescribed naloxone with a high-risk opioid divided by the total number of times a high-risk opioid prescription triggered the CDS alert.
Subsequent opioid overdose/poisonings rates

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

The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following the index visit with a high-risk opioid prescribed.
Naloxone dispensed rate

Time frame: In the 3 days after the naloxone prescription is written

The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Feb 22, 2024
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting