NCT06271668

Clinical Decision Support to Improve System Naloxone Co-prescribing

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 200,000 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 12 Years – 89 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Medication Abuse
• Harm Reduction
• Opioid Overdose
• Opioid Prescribing

Interventions

Type	Name	Description
OTHER	Naloxone Co-prescribing Clinical Decision Support (CDS)	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-10-31
• Completion: 2026-04-01
• First posted: 2024-02-22
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States