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

NCT06526286 | Not Yet Recruiting

• 2 other identifiers: 24-1188R61DA057610
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical decision support (CDS) acceptance rate

  18 months

• Subsequent opioid overdose/poisoning rates

  Six months after an encounter where the opioid use disorder is identified

• Buprenorphine initiation

  Six months after an encounter where the opioid use disorder is identified

Study Arms (2)

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)

Interventions

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

CDS Notification

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) primary care system.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction; Opioid-Related Disorders

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Narcotic-Related Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Jason Hoppe, DO

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Tolle, PhD

CONTACT

303-724-9924; heather.tolle@cuanschutz.edu

Study Design

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

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be provided to National Addiction and HIV Data Archive Program (NAHDAP) after study results are published in peer-reviewed journals.
• Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement