An observational study in Medication Abuse, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 12 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by University of Colorado, Denver · Observational
The goal of this study is to test the impact of a clinical decision support (CDS) tool to improve health care provider practices in line with state law requiring review of the Colorado prescription drug monitoring program (PDMP) before prescribing an opioid analgesic (pain medications often called narcotics) or benzodiazepine (sedatives or muscle relaxants). The PDMP is a statewide database of filled controlled medication, allowing health care providers to review medications ordered by other health care providers in the state and identify high-risk factors for overdose.
The CDS tool only appears when a relevant prescription is being written by a health care provider and is purely informational, not dictating care or changes in treatment.
The study will track how the tool is used by health care providers, if an opioid or benzodiazepine prescription is signed, and future opioid use by patients.
Improving prescription drug monitoring (PDMP) use and the safety of controlled medication prescribing is a pillar of the national response to the worsening opioid crisis. The evidence base for PDMPs would benefit greatly from research producing high quality, actionable data linking and measuring PDMP use and important patient outcomes. Data silos commonly limit the measurement of PDMP utilization and the linkage of PDMP use to provider prescribing actions. Best practice data linkage strategies can facilitate a robust evaluation of PDMP effectiveness and, specifically, the impact of Colorado's new PDMP regulations which mandate PDMP checks prior to opioid and benzodiazepine prescriptions with certain exceptions.
The objective of this project is to improve data architecture across Colorado's largest hospital system to effectively measure clinician PDMP use to address gaps in data, compliance with statutes, and important outcomes associated with new PDMP regulations. By facilitating robust evaluations of process (e.g., PDMP use, opioid prescribing) and patient outcomes (e.g., future opioid use, co-prescribing, death), this data system will expedite the measurement of PDMP effectiveness on changing opioid prescribing. Further, evaluation of clinical decision support (CDS) to promote compliance with regulation can determine if mandates result in increased PDMP use, decreased opioid exposures, high-risk prescriptions, morbidity, and mortality. This project will enhance the PDMP in three key ways:
The proposed project will achieve this using a single system, pragmatic, cluster randomized trial of CDS to deliver new state mandated PDMP regulations compared to usual care to evaluate: PDMP use, regulatory compliance, and associated patient outcomes. This will be performed across the UCHealth system in collaboration with Colorado Department of Regulatory Agencies (DORA) to maximize the quality and impact of the work and generate novel, generalizable knowledge to support the progress of PDMPs.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 89,871 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) 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) system.
Health care providers:
1. Health care providers licensed to prescribe opioids, employed at UCHealth Emergency department, ambulatory care practices or inpatient settings within the UCHealth system.
Patient encounters:
Exclusion:
Health care providers:
Patient encounters:
Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.
Providers will see a pop-up alert within the electronic health record (EHR) when they initiate an opioid or benzodiazepine prescription without recording use of the prescription drug monitoring program (PDMP) database. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders.
Other: PDMP Check CDS
Clinical decision support in the form of a EHR-integrated, provider facing alert suggesting providers consult the patient PDMP in line with State legislation.
Number of PDMP check encounters
The number of encounters where the state prescription drug monitoring program (PDMP) database is reviewed by a provider before signing an opioid or benzodiazepine prescription.
Time frame: 18 months
Initiated controlled medication prescription
The number of encounters in the observation window where an opioid or benzodiazepine prescription is signed
Time frame: 18 months
Number of high-risk opioid prescriptions
Count of opioid prescriptions with one or more active existing opioid prescriptions, an existing benzodiazepine prescription, use of long-acting opioids in an opioid naïve patient, a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high risk psychiatric diagnoses.
Time frame: 18 months
Number of patients with long term opioid use
Count of patients filling \>90 day supply of opioids
Time frame: 6 months after index visit
Number of patients with aberrant opioid use
Count of patients with opioid prescriptions filled from five or more prescribers OR five or more pharmacies.
Time frame: 6 months after index visit
Plan to share: No — IPD is not expected to shared publicly but can be requested of the PI
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver