Medication AbuseNCT06526286
Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
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 clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. 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 Use Disorder
- What is being tested?
- Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
- How many people
- 200,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to May 2027
- Phase
- Observational
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) primary care system.
Who may be able to join
- Primary care encounter AND
- Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
- Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
- Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
- Is taking >=90 morphine milligram equivalents (MME) per day OR
- Prior positive toxicology screen for illicit drugs OR
- Diagnosis of opioid use disorder
Who cannot join
- Active cancer diagnosis in the last 1 year
- Hospice care/palliative care order
- Sickle cell disease diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCHealth
Aurora, Colorado, 80045
Heather Tolle, 720-848-6777, heather.tolle@cuanschutz.edu
About this study
The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will implement a passive CDS alert when a provider prescribes an opioid to a patient who may be at risk of opioid use disorder. Providers will also have link access to a clinical care pathway providing support for OUD screening and treatment. Before and after comparisons of buprenorphine (a medication used to treat opioid use disorder) prescribing by providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.
- Conditions
- Medication Abuse, Harm Reduction, Opioid Use Disorder, Supportive Care
- Being tested
- Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)
- Medical subject headings
- Substance-Related Disorders, Harm Reduction, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)Other
Clinical decision support (CDS) in the form of an electronic health record (EHR)-integrated, provider-facing notification suggesting (a) the patient may be at risk for opioid use disorder and could benefit from screening, (b) patients with opioid use disorder would benefit from treatment with buprenorphine and (c) utilization of a clinical care pathway to help treat patients with opioid use disorder with buprenorphine as suggested by the Center for Disease Control and Prevention (CDC) guidelines.
| Study group | Role | What they receive |
|---|---|---|
| pre implementation period | Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. | |
| CDS Notification | Providers will see a clinical decision support tool within the electronic health record when treating a patient at risk for opioid use disorder to encourage the provider to use a clinical care pathway to assess for opioid use disorder and when applicable, treat opioid use disorder with buprenorphine. Smart text will also be available in the electronic health record so that the provider can easily document screening and treatment discussions with the patient. Receives: Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder
The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria
Measured: 18 months
Secondary outcomes (3)
Clinical decision support (CDS) acceptance rate
The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway in treating opioid use disorder.
Measured: 18 months
Subsequent opioid overdose/poisoning rates
The number of patients who had a diagnosis of opioid overdose or poisoning
Measured: Six months after an encounter where the opioid use disorder is identified
Buprenorphine initiation
Number of patients who filled a buprenorphine prescription after being identified at risk.
Measured: Six months after an encounter where the opioid use disorder is identified
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start7 Jul 2026
- Primary completionJan 2027 (estimated)
- Study completionMay 2027 (estimated)
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
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jason Hoppe, DO, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526286
- Sponsor's protocol ID
- 24-1188
- Other IDs
- 24-1188, R61DA057610
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) after results of the study are published.