Clinical Decision Support for Safety of Opioid Transitions

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-89
SponsorUniversity of Colorado, Denver

About this trial

The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert designed to notify providers when an opioid prescription will result in a patient transitioning into a new phase of opioid therapy. The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain recommends that providers reassess patient pain, treatment goals, and the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and from subacute to chronic opioid treatment (3 months). This study will evaluate a CDS tool that identifies patients who will be transitioning between phases of opioid therapy as a result of a prescribed opioid medication and prompts providers to review patient needs and goals of care. A pre-post study design will be used to compare provider prescribing practices and patient outcomes before and after implementation of the CDS alert. During the pre-implementation period, providers will continue routine care and will have access to existing patient pain assessments and clinical information, but no transition alert will be displayed. During the post-implementation period, providers will receive a notification when an opioid prescription results in a transition to a new phase of therapy and will be encouraged to review patient needs, reassess pain and treatment goals, and document their clinical decision-making. Opioid transition orders, provider documentation, and patient outcomes will be evaluated using medical record data collected during routine clinical care and compared between the pre-implementation and post-implementation periods.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Opioid Transitions Clinical Decision Support (CDS)

    Other intervention

    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.

Treatment groups

200,000 Participants
are divided into 2 treatment groups
Group A: pre-implementation period0 interventions
Group B: Clinical Decision Support (CDS): Opioid transition alert1 intervention

Trial outcomes

Primary outcomes

1

Percentage of encounters with an opioid transitioning prescription

The 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

Time frame
18 months

Secondary outcomes

1

Clinical decision support (CDS) acceptance rate

The number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals

Time frame
18 months
2

Subsequent opioid overdose/poisoning rates

The 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

Time frame
Six months after an encounter where the opioid use disorder is identified
3

Opioid prescription abandonment

The 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

Time frame
18 months
4

Number of patients with long term opioid use

Count of patients receiving \>90 day supply of opioids

Time frame
Six months after an encounter where the opioid use disorder is identified

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: