Clinical Decision Support for Safety of Opioid Transitions

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Harm Reduction; Medication Abuse
• Intervention / Treatment: Other: Opioid Transitions Clinical Decision Support (CDS)

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Heather Tolle, PhD; Phone Number: 303-724-9924; Email: heather.tolle@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth
      • Contact: Heather Tolle; Phone Number: 502-418-7065; Email: heather.tolle@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
pre-implementation period; Encounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. Usual care.
Clinical Decision Support (CDS): Opioid transition alert; Encounters where the opioid transition clinical decision support (CDS) alert fired. CDS logic is programmed to fire the alert when a provider places an order for an opioid that will transition the patient from acute to subacute opioid therapy (at 30 days) or from subacute to chronic opioid therapy (at 90 days).	Other: Opioid 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months
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	Six months after an encounter where the opioid use disorder is identified
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	18 months
Number of patients with long term opioid use	Count of patients receiving >90 day supply of opioids	Six months after an encounter where the opioid use disorder is identified

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jason Hoppe, DO, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): September 21, 2026
• Last Update Submitted That Met QC Criteria: September 16, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Behavior; Substance-Related Disorders; Harm Reduction
• Other Study ID Numbers: 24-1192; R61DA057610 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.

IPD Sharing Time Frame

Data will be provided to NAHDAP after study results are published in peer-reviewed journals.

IPD Sharing Access Criteria

Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No