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NCT Number: NCT06527040

Clinical Decision Support for Safety of Opioid Transitions

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.

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Key information

Age range

12 year–89 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of encounters with an opioid transitioning prescription

    Time frame: 18 months

    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

Secondary outcomes

  1. Clinical decision support (CDS) acceptance rate

    Time frame: 18 months

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

  2. Subsequent opioid overdose/poisoning rates

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

    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

  3. Opioid prescription abandonment

    Time frame: 18 months

    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

  4. Number of patients with long term opioid use

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

    Count of patients receiving >90 day supply of opioids

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Tolle, PhD

CONTACT

[email protected]

303-724-9924

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 30, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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