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Clinical Decision Support for Safety of Opioid Transitions

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 2026 → Apr 2027
See other at-risk trials from University of Colorado, Denver

Record History

  1. Start date: Jun 2026 to Dec 2026 Primary completion pushed from Dec 2026 to Apr 2027 · Study sites: 0 to 1 · Secondary endpoints: details revised at 2 of 4 entries · 1 more Show 4 more changesShow less
    • Primary completion pushed from Dec 2026 to Apr 2027
    • Study sites: 0 to 1
    • Secondary endpoints: details revised at 2 of 4 entries
    • Eligibility criteria expanded, about 2 words
  2. Start date: Feb 2026 to Jun 2026v6
  3. Start date: Dec 2025 to Feb 2026v5
  4. Start date: Sep 2025 to Dec 2025 Primary completion date: Sep 2026 to Dec 2026 · Completion date: Mar 2027 to Jun 2027v4 Show 2 more changesShow less
    • Primary completion date: Sep 2026 to Dec 2026
    • Completion date: Mar 2027 to Jun 2027
  5. Start date: Mar 2025 to Sep 2025v3
  6. Start date: Oct 2024 to Mar 2025 Primary completion date: Apr 2026 to Sep 2026 · Completion date: Oct 2026 to Mar 2027v2 Show 2 more changesShow less
    • Primary completion date: Apr 2026 to Sep 2026
    • Completion date: Oct 2026 to Mar 2027
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06527040
Lead Sponsor University of Colorado, Denver
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Conditions Medication Abuse, Harm Reduction
Enrollment 200,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov