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NCT Number: NCT06526286

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder

    Time frame: 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 outcomes

  1. Clinical decision support (CDS) acceptance rate

    Time frame: 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.

  2. Subsequent opioid overdose/poisoning rates

    Time frame: 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

  3. Buprenorphine initiation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Tolle, PhD

CONTACT

[email protected]

303-724-9924

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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