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

NCT ID: NCT06526286

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-05-31

Brief Summary

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.

Conditions

Medication Abuse; Harm Reduction; Opioid Use Disorder; Supportive Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Usual Care

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

No interventions assigned to this group

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.

Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Central Contacts

Heather Tolle, PhD

Role: CONTACT

heather.tolle@cuanschutz.edu

303-724-9924

Other Identifiers

24-1188

Identifier Type: OTHER

Identifier Source: secondary_id

R61DA057610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1188

Identifier Type: -

Identifier Source: org_study_id