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Not yet recruiting NCT06527079

Evaluation of Clinical Decision Support in Opioid Tapering

Observational Medication Abuse Harm Reduction Opioid Use Disorder Opioid Prescribing

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Opioid Tapering Pathway Clinical Decision Support (CDS).
Who it may be relevant to
Registry conditions: Medication Abuse, Harm Reduction, Opioid Use Disorder, Opioid Prescribing. Basic parameters: 12 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Opioid Tapering Pathway Clinical Decision Support (CDS)
    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 outcome measures

  • Percentage of encounters tapering within CDC guidelines [Time frame: 18 months]
Secondary outcome measures (3)
  • Clinical decision support (CDS) acceptance rate [Time frame: 18 months]
  • Subsequent opioid overdose/poisoning rates [Time frame: 6 months after taper encounter]
  • Health care utilization [Time frame: 6 months after taper encounter]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06527079 · 24-1193 · 24-1193 · R61DA057610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗