An observational study in Medication Abuse and Harm Reduction, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Colorado, Denver · Observational
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert designed to notify providers when an opioid prescription will result in a patient transitioning into a new phase of opioid therapy. The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain recommends that providers reassess patient pain, treatment goals, and the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and from subacute to chronic opioid treatment (3 months). This study will evaluate a CDS tool that identifies patients who will be transitioning between phases of opioid therapy as a result of a prescribed opioid medication and prompts providers to review patient needs and goals of care. A pre-post study design will be used to compare provider prescribing practices and patient outcomes before and after implementation of the CDS alert. During the pre-implementation period, providers will continue routine care and will have access to existing patient pain assessments and clinical information, but no transition alert will be displayed. During the post-implementation period, providers will receive a notification when an opioid prescription results in a transition to a new phase of therapy and will be encouraged to review patient needs, reassess pain and treatment goals, and document their clinical decision-making. Opioid transition orders, provider documentation, and patient outcomes will be evaluated using medical record data collected during routine clinical care and compared between the pre-implementation and post-implementation periods.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 200,000 is above the median of 251 across 299 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system and receive an opioid prescription.
Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)
Exclusion Criteria:
Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. Usual care.
Encounters where the opioid transition clinical decision support (CDS) alert fired. CDS logic is programmed to fire the alert when a provider places an order for an opioid that will transition the patient from acute to subacute opioid therapy (at 30 days) or from subacute to chronic opioid therapy (at 90 days).
Other: Opioid Transitions Clinical Decision Support (CDS)
Clinical decision support in the form of an electronic health record (EHR) integrated, provider-facing alert suggesting (a) the patient is transitioning to a new phase of opioid therapy and (b) the provider should review patient pain data and pain management goals as suggested by Center for Disease Control and Prevention (CDC) guidelines.
Percentage of encounters with an opioid transitioning prescription
The number of primary care encounters where an opioid prescription transitions a patient to a different phase of care (by phase) divided by the total number of opioid prescriptions
Time frame: 18 months
Clinical decision support (CDS) acceptance rate
The number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals
Time frame: 18 months
Subsequent opioid overdose/poisoning rates
The number of patients who reached the threshold of chronic opioid use, had a diagnosis of opioid overdose/poisoning or a new diagnosis of opioid use disorder
Time frame: Six months after an encounter where the opioid use disorder is identified
Opioid prescription abandonment
The proportion of opioid prescriptions initiated (triggering the CDS) and an opioid was not signed by the provider, indicating a change in clinical decision to prescribe an opioid
Time frame: 18 months
Number of patients with long term opioid use
Count of patients receiving \>90 day supply of opioids
Time frame: Six months after an encounter where the opioid use disorder is identified
Plan to share: Yes — De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.
Supporting information: Study protocol
Time frame: Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
Access criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
Data sharing details ↗ · www.icpsr.umich.edu
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
Of 122 non-industry observational studies under Substance-Related Disorders, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 56. This study's planned 4 months is below that.
Counting every sponsor, half of 133 studies reached it within 36 months; a quarter within 18 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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