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Clinical Decision Support for Safety of Opioid Transitions

Clinical Decision Support for Safety of Opioid Transitions

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06527040
Enrollment
200000
Registered
2024-07-30
Start date
2026-06-01
Completion date
2027-06-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Harm Reduction, Medication Abuse

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.

Interventions

OTHEROpioid Transitions Clinical Decision Support (CDS)

Clinical decision support in the form of an electronic health record (EHR) integrated, provider-facing alert suggesting (a) the patient is transitioning to a new phase of opioid therapy and (b) the provider should review patient pain data and pain management goals as suggested by Center for Disease Control and Prevention (CDC) guidelines.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of encounters with an opioid transitioning prescription18 monthsThe number of primary care encounters where an opioid prescription transitions a patient to a different phase of care (by phase) divided by the total number of opioid prescriptions

Secondary

MeasureTime frameDescription
Clinical decision support (CDS) acceptance rate18 monthsThe number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals
Subsequent opioid overdose/poisoning ratesSix months after an encounter where the opioid use disorder is identifiedThe number of patients who reached the threshold of chronic opioid use, had a diagnosis of opioid overdose/poisoning or a new diagnosis of opioid use disorder
Opioid prescription abandonment18 monthsThe proportion of opioid prescriptions initiated (triggering the CDS) and an opioid was not signed by the provider, indicating a change in clinical decision to prescribe an opioid
Number of patients with long term opioid useSix months after an encounter where the opioid use disorder is identifiedCount of patients receiving \>90 day supply of opioids

Contacts

CONTACTHeather Tolle, PhD
heather.tolle@cuanschutz.edu303-724-9924
PRINCIPAL_INVESTIGATORJason Hoppe, DO

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026