Clinical Decision Support to Improve System Naloxone Co-prescribing

NCT ID: NCT06271668

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Naloxone Co-prescribing Clinical Decision Support (CDS)

Intervention Type: 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.

Usual Care

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

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason A Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Countries

United States

Other Identifiers

R61DA057610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-2356

Identifier Type: -

Identifier Source: org_study_id