Clinical Decision Support to Improve System Naloxone Co-prescribing

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Harm Reduction; Medication Abuse
• Intervention / Treatment: Other: Naloxone Co-prescribing Clinical Decision Support (CDS)

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.

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Heather Tolle, PhD; Phone Number: 303-724-9924; Email: heather.tolle@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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]; ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER; OPIOID SCRIPT BEING PLACED CRITERIA; DAILY Milligram Morphine Equivalent (MME) >=90 UNSIGNED ORDER; DAILY MME >=90 EXISTING; DIAGNOSIS OF OPIOID USE DISORDER; DIAGNOSIS HISTORY OF OPIOID OVERDOSE; PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS; DISCHARGE TO HOSPICE	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.
Usual Care; Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jason A Hoppe, DO, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: 23-2356; R61DA057610 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data utilized in this project will be housed on the National Institute on Drug Abuse (NIDA) Data Share Website.
• IPD Sharing Time Frame: Data will be posted to the data share site after study results are published in peer-reviewed journals.
• IPD Sharing Access Criteria: Prior to downloading study data the individual will have to register with the site and agree to a standard data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No