Clinical trial NCT06271668: Clinical Decision Support to Improve System Naloxone Co-prescribing
Official title: Clinical Decision Support to Improve System Naloxone Co-prescribing
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Medication Abuse
Harm Reduction
Opioid Overdose
Opioid Prescribing
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-02-22
Enrollment: 200000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.

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.

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

Primary outcomes:
measure: Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone
timeFrame: 18 months
Secondary outcomes:
measure: Clinical decision support (CDS) acceptance rate
timeFrame: 18 months
measure: Subsequent opioid overdose/poisonings rates
timeFrame: Six months after an encounter where the naloxone clinical decision support fired for the provider
measure: Naloxone dispensed rate
timeFrame: In the 3 days after the naloxone prescription is written
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jason A Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References: