Clinical Decision Support to Improve System Naloxone Co-prescribing

Harm Reduction Clinical Trial

Official title:

Clinical Decision Support to Improve System Naloxone Co-prescribing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271668
• Other study ID #: 23-2356
• Secondary ID: R61DA057610
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: Heather Tolle, PhD
• Phone: 303-724-9924
• Email: heather.tolle[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200000
• Est. completion date: September 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Harm Reduction

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Aurora	Colorado

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone	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.	18 months
Secondary	Clinical decision support (CDS) acceptance rate	The 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.	18 months
Secondary	Subsequent opioid overdose/poisonings rates	The 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.	Six months after an encounter where the naloxone clinical decision support fired for the provider
Secondary	Naloxone dispensed rate	The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.	In the 3 days after the naloxone prescription is written