Clinical trial NCT06527040: Clinical Decision Support for Safety of Opioid Transitions
Official title: Clinical Decision Support for Safety of Opioid Transitions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Medication Abuse
Harm Reduction
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: 2024-07-30
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 and receive an opioid prescription.

Brief summary: The objective of this study is to evaluate the impact of clinical decision support (CDS) alert to notify providers when the opioid prescription being written will result in the patient transitioning into a new phase of opioid therapy. The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends providers reassess patient pain as well as the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and when patients transition from subacute to chronic opioid treatment (3 months). This study will evaluate a clinical decision support tool identifying patients who will be transitioning between phases as a result of an opioid prescription and suggest a review of patient pain and goals. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will not be notified that the prescription transitions the patient to a new phase but will have access to the same patient pain scales and information. The intervention arm will receive a notification of the transition and suggest review of patient needs and encourage documentation. Opioid transition orders and outcomes of patients will be examined based on medical records data collected during routine care.


Eligibility criteria: Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)

Exclusion Criteria:

* Patients \<12 and \>89
* Patients with active cancer diagnosis in last 1 year
* Patients with hospice care/palliative care order
* Patients with sickle cell disease diagnosis

Primary outcomes:
measure: Percentage of encounters with an opioid transitioning prescription
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: Opioid prescription abandonment
timeFrame: 18 months
measure: Number of patients with long term opioid use
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: