Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder

The objective of this study is to evaluate the impact of clinical decision support (CDS) in the form of an alert to identify patients who may be at risk of opioid use disorder (OUD) and a clinical care pathway helping providers treating patients with opioid use disorder. The pathway provides health care providers with information and suggestions for screening and treatment of opioid use disorder, including treatment with medications. The 2022 Centers for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends providers asses for and treat opioid use disorder using approved medications for opioid use disorder (MOUD). This project will randomize primary care providers at the clinic level to a control arm or intervention arm. The control arm will have access to the clinical care pathway, but will not be reminded to utilize the pathway when treating a patient with opioid use disorder. The intervention arm will receive a reminder nudge about the pathway. Buprenorphine (a medication used to treat opioid use disorder) prescribing behavior of providers and outcomes of patients will be examined based on medical records data collected during routine care. The study period will be approximately 18 months.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder; Harm Reduction; Supportive Care; Medication Abuse
• Intervention / Treatment: Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Heather Tolle, PhD; Phone Number: 303-724-9924; Email: heather.tolle@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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) primary care system.

Description

Inclusion Criteria:

• Primary care encounter AND
• Current opioid prescription (not buprenorphine) and Active opioid medications over the last 90 days OR
• Documented as on local Pain Registry "Does the patient fit the criteria to be included on the Pain Registry?" OR
• Has active problem list diagnosis of long-term (current) use of opiate analgesic OR
• Is taking >=90 morphine milligram equivalents (MME) per day OR
• Prior positive toxicology screen for illicit drugs OR
• Diagnosis of opioid use disorder

Exclusion Criteria:

• Active cancer diagnosis in the last 1 year
• Hospice care/palliative care order
• Sickle cell disease diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Usual Care; Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.
CDS Notification; Providers will see a clinical decision support tool within the electronic health record when treating a patient at risk for opioid use disorder to encourage the provider to use a clinical care pathway to assess for opioid use disorder and when applicable, treat opioid use disorder with buprenorphine. Smart text will also be available in the electronic health record so that the provider can easily document screening and treatment discussions with the patient.	Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS); Clinical decision support (CDS) in the form of an electronic health record (EHR)-integrated, provider-facing notification suggesting (a) the patient may be at risk for opioid use disorder and could benefit from screening, (b) patients with opioid use disorder would benefit from treatment with buprenorphine and (c) utilization of a clinical care pathway to help treat patients with opioid use disorder with buprenorphine as suggested by the Center for Disease Control and Prevention (CDC) guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder	The number of primary care patients identified to be at risk for opioid use disorder treatment with buprenorphine for treatment divided by the total number of patients meeting opioid use disorder criteria	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subsequent opioid overdose/poisoning rates	The number of patients who had a diagnosis of opioid overdose or poisoning	Six months after an encounter where the opioid use disorder is identified
Buprenorphine initiation	Number of patients who filled a buprenorphine prescription after being identified at risk.	Six months after an encounter where the opioid use disorder is identified
Clinical decision support (CDS) acceptance rate	The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway in treating opioid use disorder.	18 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jason Hoppe, DO, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Chemically-Induced Disorders; Behavior; Opioid-Related Disorders; Substance-Related Disorders; Harm Reduction; Pharmaceutical Preparations; Investigative Techniques; Technology, Pharmaceutical; Dosage Forms
• Other Study ID Numbers: 24-1188 (Other Identifier: IRB protocol); R61DA057610 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) after results of the study are published.
• IPD Sharing Time Frame: Data will be provided to National Addiction and HIV Data Archive Program (NAHDAP) after study results are published in peer-reviewed journals.
• IPD Sharing Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No