Evaluation of Clinical Decision Support in Opioid Tapering

NCT06527079 — Not yet recruiting, 200000 participants, University of Colorado, Denver
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RegistryNCT06527079
StatusNot yet recruiting
Study typeObservational
Enrollment200000 (Estimated)
SponsorUniversity of Colorado, Denver (Other); collaborators: National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)
ConditionsMedication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing, Opioid Overdose, Prevention
InterventionsObservational study without a prospective intervention (Other)
Datesstart 2026-11-01 (estimated), primary completion 2027-03-01 (estimated), completion 2027-06-01 (estimated), first posted 2024-07-30, last updated 2026-09-30

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-Summary

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 examine the state of tapering in primary care across the system as well as conduct stakeholder interviews to understand the resources available across the system to support providers in tapering and identify opportunities for clinical decision support to be implemented to support guideline concordant tapering. Utilization of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering will be examined. The rate of opioid tapering in line with CDC guidelines will be examined as well as long term patient outcomes of opioid overdose of poisoning using existing patient health records. The study period will be approximately 8 months.

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+Arms and interventions

ArmTypeInterventionsDescription
Usual CareOther: Observational study without a prospective interventionControl group to enable tracking of temporal changes in prescribing. Providers will not see any alert.
  • Observational study without a prospective intervention (Other): observational study without a prospective intervention

+Outcome measures

Primary outcomes

  • Percentage of potential taper-benefit patients [8 months]: The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial

Secondary outcomes

  • Observed tapering [8 months]: The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly as an indication of tapering
  • Taper magnitude [8 months]: The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly at a rate in line with guideline recommendations

+Eligibility

Sex: All, ages: 12 Years to 89 Years

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

+Investigators

+Funding

NIH grants: R61DA057610