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NCT Number: NCT06527079

Evaluation of Clinical Decision Support in Opioid Tapering

The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will evaluate a clinical decision support (CDS) tool in the form of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will have the clinical care pathway available, but will not be reminded of the pathway when tapering a patient. The intervention arm will receive a nudge when prescribing a tapering opioid strategy to a patient to use the clinical care pathway. The rate of opioid tapering in line with CDC guidelines will be examined as well as long-term patient outcomes of opioid overdose or poisoning using existing patient health records. The study period will be approximately 18 months.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Primary care patients being tapered from an opioid. Tapering patients:

  • Have an active opioid prescription for more than 3 months and
  • Prescribed more than 90 morphine milligram equivalents (MME) per day or
  • Co-prescribed an opioid and benzodiazepine or
  • Received a reduction in opioid dosage by more than 5% MME per day

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 Tapering Pathway Clinical Decision Support (CDS)

Other

Clinical decision support in the form of an electronic health record (EHR)-integrated, provider facing notification suggesting the provider utilize a clinical care pathway that provides resources and decision support in opioid tapering in line with CDC guidelines.

Primary outcomes

  1. Percentage of encounters tapering within CDC guidelines

    Time frame: 18 months

    The number of encounters where a provider's actions are in line with CDC tapering guidelines divided by the total number of opioid tapering 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 utilized the clinical care pathway

  2. Subsequent opioid overdose/poisoning rates

    Time frame: 6 months after taper encounter

    The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following an opioid tapering prescription

  3. Health care utilization

    Time frame: 6 months after taper encounter

    The number of emergency department and clinic visits

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 23, 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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