Medication AbuseNCT06271668
Clinical Decision Support to Improve System Naloxone Co-prescribing
An observational study of Medication Abuse and Harm Reduction, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Abuse, Harm Reduction, Opioid Overdose
- What is being tested?
- Naloxone Co-prescribing Clinical Decision Support (CDS)
- How many people
- 114,272 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.
Who may be able to join
- Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
- Being tested
- Naloxone Co-prescribing Clinical Decision Support (CDS)
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Opiate Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naloxone Co-prescribing Clinical Decision Support (CDS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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]
1. ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER
2. OPIOID SCRIPT BEING PLACED CRITERIA
3. DAILY Milligram Morphine Equivalent (MME) >=90 UNSIGNED ORDER
4. DAILY MME >=90 EXISTING
5. DIAGNOSIS OF OPIOID USE DISORDER
6. DIAGNOSIS HISTORY OF OPIOID OVERDOSE
7. PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS
8. DISCHARGE TO HOSPICE Receives: Other: Naloxone Co-prescribing Clinical Decision Support (CDS) | |
| Usual Care | Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: Six months after an encounter where the naloxone clinical decision support fired for the provider
Naloxone dispensed rate
The number of patients who were dispensed a naloxone prescription divided by the number of naloxone prescriptions written.
Measured: In the 3 days after the naloxone prescription is written
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2025
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AbuseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114,272 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jason A Hoppe, DO, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271668
- Sponsor's protocol ID
- 23-2356
- Other IDs
- R61DA057610
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support to Improve System Naloxone Co-prescribing
- ClinicalTrials.gov ID
- NCT06271668
- Acronym / sponsor ID
- 23-2356
- Conditions
- Medication Abuse, Harm Reduction, Opioid Overdose, Opioid Prescribing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114,272 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support (CDS): Naloxone Alert | – | Other: Naloxone Co-prescribing Clinical Decision Support (CDS)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] 1. ACTIVE OR PENDED NALOXONE PRESCRIPTION ORDER 2. OPIOID SCRIPT BEING PLACED CRITERIA 3. DAILY Milligram Morphine Equivalent (MME) >=90 UNSIGNED ORDER 4. DAILY MME >=90 EXISTING 5. DIAGNOSIS OF OPIOID USE DISORDER 6. DIAGNOSIS HISTORY OF OPIOID OVERDOSE 7. PROVIDER LOGGED INTO ELLIGIBLE DEPARTMENTS 8. DISCHARGE TO HOSPICE |
| Usual Care | – | –Control group of contemporary encounters where clinical decision support (CDS) is not active. Usual care. |
Who may qualify
- Ages
- 12 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.
Key inclusion criteria (1 listed)
- Patients receiving an opioid prescription at discharge from inpatient/ED or close visit in outpatient settings where the clinical decision support (CDS) is implemented
Key exclusion criteria (6 listed)
- Patients <12 and >89 year of age
- Cancer diagnosis
- Hospice care/palliative care
- Sickle cell disease diagnosis
- Patients who arrived in error
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Clinical Decision Support (CDS): Naloxone Alert |
Primary outcome
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.
3 secondary outcomes
Clinical decision support (CDS) acceptance rate
Time frame: 18 months
Subsequent opioid overdose/poisonings rates
Time frame: Six months after an encounter where the naloxone clinical decision support fired for the provider
Naloxone dispensed rate
Time frame: In the 3 days after the naloxone prescription is written
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason A Hoppe, DO principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Abuse and Harm Reduction, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of a high-risk opioid analgesic prescriptions receiving a co-prescription of naloxone (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.