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Clinical Trials/NCT06527079
NCT06527079
Not yet recruiting
Not Applicable

Evaluation of Clinical Decision Support in Opioid Tapering

University of Colorado, Denver0 sites200,000 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
200,000
Primary Endpoint
Percentage of encounters tapering within CDC guidelines

Overview

Brief 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 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Years to 89 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

  • Subsequent opioid overdose/poisoning rates(6 months after taper encounter)
  • Health care utilization(6 months after taper encounter)
  • Clinical decision support (CDS) acceptance rate(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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