Clinical trial NCT06526286: Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
Official title: Clinical Decision Support to Increase Use of Medications for Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Medication Abuse
Harm Reduction
Opioid Use Disorder
Supportive Care
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-07-29
Enrollment: 200000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percentage of patients at risk for opioid use disorder receiving medications for opioid use disorder
timeFrame: 18 months
Secondary outcomes:
measure: Clinical decision support (CDS) acceptance rate
timeFrame: 18 months
measure: Subsequent opioid overdose/poisoning rates
timeFrame: Six months after an encounter where the opioid use disorder is identified
measure: Buprenorphine initiation
timeFrame: Six months after an encounter where the opioid use disorder is identified
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Jason Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References: