Medication AbuseNCT06215560
A Prospective Evaluation of Colorado's New Statutory PDMP Mandates: Compliance and Patient Outcomes
An observational study of Medication Abuse, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… 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
- What is being tested?
- PDMP Check CDS
- How many people
- 89,871 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 10 Jan 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
- 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:
- Patients seen in the UCHealth Emergency Department, outpatient clinic/office or inpatient setting during the intervention period
- Provider initiates a prescription for an opioid or benzodiazepine
- patient is between 12-89 years of age, inclusive
Who cannot join
- Health care providers:
- Providers primarily practicing in dentistry, veterinary medicine, oncology, pediatrics, palliative, or hospice practices.
- Providers in ambulatory practices (primary care and specialty clinics) which write a total of less than 52 opioids and benzodiazepine prescriptions in the year prior to study initiation.
- Patient encounters:
- Encounters in dentistry, veterinary medicine, oncology practices, pediatrics practices, palliative care or hospice practices
- Prisoners or wards of the state
- Age <12 or >89 YOA
- Active diagnosis of sickle cell, cancer, or in hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
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:
- Address inefficiencies of collecting PDMP use data. Improved collection of PDMP data at the patient visit level will allow for rapid analysis of PDMP use and interventions.
- Implement effective PDMP interventions. PDMP CDS tools can accelerate the uptake of mandated PDMP actions while routine data collection can be used to assess outcomes.
- Address sustainability. Health system wide implementation will strengthen capacity to rapidly evaluate the effectiveness of multiple new PDMP policy interventions.
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.
- Conditions
- Medication Abuse
- Being tested
- PDMP Check CDS
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDMP Check CDSOther
Clinical decision support in the form of a EHR-integrated, provider facing alert suggesting providers consult the patient PDMP in line with State legislation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. | |
| CDS 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. Receives: Other: PDMP Check CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Initiated controlled medication prescription
The number of encounters in the observation window where an opioid or benzodiazepine prescription is signed
Measured: 18 months
Secondary outcomes (3)
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.
Measured: 18 months
Number of patients with long term opioid use
Count of patients filling >90 day supply of opioids
Measured: 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.
Measured: 6 months after index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start9 Jan 2025
- Primary completion30 Jul 2025
- Study completion10 Jan 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
- 89,871 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Jason A Hoppe, DO, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215560
- Sponsor's protocol ID
- 23-0885
- Other IDs
- 15PBJA-22-GK-03114-PDMP
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not expected to shared publicly but can be requested of the PI
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Colorado's New Statutory PDMP Mandates: Compliance and Patient Outcomes
- ClinicalTrials.gov ID
- NCT06215560
- Acronym / sponsor ID
- 23-0885
- Conditions
- Medication Abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89,871 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 22 Jan 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 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.
Detailed description
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:
- Address inefficiencies of collecting PDMP use data. Improved collection of PDMP data at the patient visit level will allow for rapid analysis of PDMP use and interventions.
- Implement effective PDMP interventions. PDMP CDS tools can accelerate the uptake of mandated PDMP actions while routine data collection can be used to assess outcomes.
- Address sustainability. Health system wide implementation will strengthen capacity to rapidly evaluate the effectiveness of multiple new PDMP policy interventions.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | – | –Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert. |
| CDS Alert | – | Other: PDMP Check CDSProviders 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. |
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 (6 listed)
- 1. Health care providers licensed to prescribe opioids, employed at UCHealth Emergency department, ambulatory care practices or inpatient settings within the UCHealth system.
- Patients seen in the UCHealth Emergency Department, outpatient clinic/office or inpatient setting during the intervention period
- Provider initiates a prescription for an opioid or benzodiazepine
- patient is between 12-89 years of age, inclusive
Key exclusion criteria (8 listed)
- Providers primarily practicing in dentistry, veterinary medicine, oncology, pediatrics, palliative, or hospice practices.
- Providers in ambulatory practices (primary care and specialty clinics) which write a total of less than 52 opioids and benzodiazepine prescriptions in the year prior to study initiation.
- Encounters in dentistry, veterinary medicine, oncology practices, pediatrics practices, palliative care or hospice practices
- Prisoners or wards of the state
- Age <12 or >89 YOA
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 |
|---|---|---|
| PDMP Check CDSClinical decision support in the form of a EHR-integrated, provider facing alert suggesting providers consult the patient PDMP in line with State legislation. | Other | CDS Alert |
Primary outcome
Number of PDMP check encounters
Time frame: 18 months
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.
Initiated controlled medication prescription
Time frame: 18 months
The number of encounters in the observation window where an opioid or benzodiazepine prescription is signed
3 secondary outcomes
Number of high-risk opioid prescriptions
Time frame: 18 months
Number of patients with long term opioid use
Time frame: 6 months after index visit
Number of patients with aberrant opioid use
Time frame: 6 months after index visit
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 23 Apr 2026.
- Individual participant dataSharing planned: No. IPD is not expected to shared publicly but can be requested of the PI
Related trials for Medication Abuse
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Active, not recruiting
Implementing PrEP for Women Who Inject Drugs
HIV, Intravenous Substance Abuse
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, 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 6 inclusion and 8 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 23 Apr 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?
Number of PDMP check encounters (time frame: 18 months). The study lists 2 primary outcomes in all. 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 23 Apr 2026.