NCT04918355

Brief Summary

This is a study comparing three clinical decision support (CDS) tools to enhance care by easing health care provider review of the Colorado prescription drug monitoring program (PDMP) prior to prescribing opioids (pain medications often called narcotics) or benzodiazepines (sedatives or muscle relaxants). The tools screen information from the PDMP (a statewide database of filled controlled medication) and a patient's medical record to identify high-risk factors for overdose. The tools only appear when relevant, are purely informational to facilitate an evidence-based practice (PDMP review) and do not dictate care or suggest changes in treatment. The study will track how each of the tools are used and if providers use the PDMP. Secondary outcomes include if a controlled medication prescription was written and future opioid use by patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,635

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 16, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

September 16, 2025

Completed
Last Updated

September 16, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

June 2, 2021

Results QC Date

May 3, 2024

Last Update Submit

August 27, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of PDMP Checks Conducted During High-risk Prescriptions

    Differences between groups in the percentage of opioid or benzodiazepine prescriptions with one or more high risk prescribing criteria for whom the health care provider consults the Prescription Drug Monitoring Program (PDMP) prior to signing, in line with prescribing best practices.

    Total over the course of one year

Secondary Outcomes (2)

  • Percentage of High-risk Controlled Medication Prescriptions Abandoned

    Total over the course of one year

  • Long Term Opioid Use

    Total over the course of one year

Study Arms (4)

Provider Group 1: no alert

Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.

Provider Group 2: Mandated alert

Control group where providers will see a generic pop-up alert within the Electronic Health Record (EHR) whenever they initiate an opioid or benzodiazepine prescription without recording use of the PDMP. Patient risk factors are not assessed or presented in the alert. Providers in ambulatory clinics will not be assigned to this group. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.

Other: Clinical Decision Support (CDS) alerts

Provider Group 3: PDMP 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 PDMP and patients have one or more positive risk factors based on past/current prescriptions received. Patient risk factors are assessed and presented in the alert. Risk factors included are numbers of active or recent opioid and benzodiazepine prescriptions, overlapping prescriptions, co-prescribing of benzodiazepines and opioids, and use of long-acting opioids in opioid naïve patients. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.

Other: Clinical Decision Support (CDS) alerts

Provider Group 4: PDMP + EHR 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 PDMP and patients have one or more positive risk factors based on both prescriptions and other factors recorded in the patient's EHR. Patient risk factors are assessed and presented in the alert. Risk factors included the risks described in Group 3, along with a history of accidental opioid overdose, diagnosis of Opioid Use Disorder, multiple recent acute care incidents with opioid use, or high-risk psychiatric diagnoses. Alerts do not appear with patients with oncology or sickle cell diagnoses, or hospice discharge orders. Clinical Decision Support (CDS) alerts: CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.

Other: Clinical Decision Support (CDS) alerts

Interventions

CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.

Provider Group 2: Mandated alertProvider Group 3: PDMP alertProvider Group 4: PDMP + EHR alert

Eligibility Criteria

Age12 Years - 89 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Provider population: Health care providers in Colorado who work in the University of Colorado Health (UCHealth) system. Patient population: Residents and visitors to the state of Colorado who seek healthcare within the UCHealth system.

You may qualify if:

  • Licensed health care providers within the UCHealth system with a history (previous year) of prescribing opioids and/or benzodiazepines.

You may not qualify if:

  • Majority of prescribing is done at a facility outside the state of Colorado
  • Provider specialty of oncology or pediatrics as recorded in the EHR
  • Provider in an ambulatory clinic where a total of \<50 opioid or benzodiazepine prescriptions were written in the year before study initiation
  • Patient seen by a randomized provider within the UCHealth system who may receive an opioid prescription
  • Less than 12 years of age or greater than 89 years of age at the time of the first study associated visit
  • Active oncology or sickle cell diagnosis
  • Active end of life care (defined as discharge to hospice or palliative care facility or specific palliative care orders in the medical record)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Compact DisksCaffeine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Videodisc RecordingOptical Storage DevicesAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Providers were randomized, health visits in which an opioid or benzodiazepine was prescribed were analyzed.

Results Point of Contact

Title
Heather Tolle
Organization
University of Colorado

Study Officials

  • Jason A Hoppe, DO

    University of Colorado School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

February 16, 2021

Primary Completion

May 30, 2023

Study Completion

November 30, 2023

Last Updated

September 16, 2025

Results First Posted

September 16, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations