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Clinical Trials/NCT06271668
NCT06271668
Enrolling By Invitation
Not Applicable

Clinical Decision Support to Improve System Naloxone Co-prescribing

University of Colorado, Denver1 site in 1 country200,000 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Medication Abuse
Sponsor
University of Colorado, Denver
Enrollment
200000
Locations
1
Primary Endpoint
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
Status
Enrolling By Invitation
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
April 1, 2026
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

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

  • Naloxone dispensed rate(In the 3 days after the naloxone prescription is written)
  • 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)

Study Sites (1)

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