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Clinical Decision Support to Improve System Naloxone Co-prescribing

Clinical Decision Support to Improve System Naloxone Co-prescribing

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06271668
Enrollment
200000
Registered
2024-02-22
Start date
2024-07-01
Completion date
2026-10-01
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Harm Reduction, Medication Abuse, Opioid Overdose, Opioid Prescribing

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.

Interventions

OTHERNaloxone 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone18 monthsThe 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

MeasureTime frameDescription
Clinical decision support (CDS) acceptance rate18 monthsThe 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 ratesSix months after an encounter where the naloxone clinical decision support fired for the providerThe 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 rateIn the 3 days after the naloxone prescription is writtenThe number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJason A Hoppe, DO

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026