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Not yet recruiting NCT06526286

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

Observational Medication Abuse Harm Reduction Opioid Use Disorder Supportive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medications for Opioid Use Disorder Pathway Clinical Decision Support (CDS).
Who it may be relevant to
Registry conditions: Medication Abuse, Harm Reduction, Opioid Use Disorder, Supportive Care. Basic parameters: 12 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder [Time frame: 18 months]
Secondary outcome measures (3)
  • Clinical decision support (CDS) acceptance rate [Time frame: 18 months]
  • Subsequent opioid overdose/poisoning rates [Time frame: Six months after an encounter where the opioid use disorder is identified]
  • Buprenorphine initiation [Time frame: Six months after an encounter where the opioid use disorder is identified]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06526286 · 24-1188 · 24-1188 · R61DA057610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗