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

Not yet recruiting

• Conditions: Medication Abuse; Harm Reduction; Opioid Use Disorder; Supportive Care
• Interventions: Other: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)

• Registration Number: NCT06526286
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-29
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-03
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200000

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDS Notification	Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS)	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder	18 months	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

Secondary Outcome Measures

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