A Prospective Evaluation of Colorado's New Statutory PDMP Mandates: Compliance and Patient Outcomes

NCT06215560 | Completed

• 2 other identifiers: 23-088515PBJA-22-GK-03114-PDMP
• Study Type: observational
• Target: 89,871
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Medication Abuse

Outcome Measures

Primary Outcomes (2)

• 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.

  18 months

• Initiated controlled medication prescription

  The number of encounters in the observation window where an opioid or benzodiazepine prescription is signed

  18 months

Secondary Outcomes (3)

• Number of high-risk opioid prescriptions

  18 months

• Number of patients with long term opioid use

  6 months after index visit

• Number of patients with aberrant opioid use

  6 months after index visit

Study Arms (2)

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.

Other: PDMP Check CDS

Interventions

PDMP Check CDS OTHER

Clinical decision support in the form of a EHR-integrated, provider facing alert suggesting providers consult the patient PDMP in line with State legislation.

CDS Alert

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) system.

You may qualify if:

• Health care providers:
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• U.S. Department of Justice: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jason A Hoppe, DO

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: January 9, 2025
• Primary Completion: July 30, 2025
• Study Completion: January 10, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)