Clinical Decision Support for Safety of Opioid Transitions

NCT06527040 | Not Yet Recruiting

• 2 other identifiers: 24-1192R61DA057610
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Harm Reduction; Medication Abuse

Outcome Measures

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

  18 months

Secondary Outcomes (4)

• Clinical decision support (CDS) acceptance rate

  18 months

• Subsequent opioid overdose/poisoning rates

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

• Opioid prescription abandonment

  18 months

• Number of patients with long term opioid use

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

Study Arms (2)

Usual Care

Control group of contemporary encounters where clinical decision support alert is not active. 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)

Interventions

Opioid Transitions Clinical Decision Support (CDS) OTHER

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.

Clinical Decision Support (CDS): Opioid transition alert

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Officials

• Jason Hoppe, DO

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Tolle, PhD

CONTACT

303-724-9924; heather.tolle@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
• Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.