Evaluation of Clinical Decision Support in Opioid Tapering

Not yet recruiting

• Conditions: Medication Abuse; Harm Reduction; Opioid Use Disorder; Opioid Prescribing; Opioid Overdose; Prevention
• Interventions: Other: Opioid Tapering Pathway Clinical Decision Support (CDS)

• Registration Number: NCT06527079
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Study First Posted: 2024-07-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-05
• Primary Completion: 2026-11
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CDS Notification	Opioid Tapering Pathway Clinical Decision Support (CDS)	Providers will see a clinical decision support tool within the electronic health record when treating a patient who may benefit from or is currently tapering opioid medications to encourage the provider to use a clinical care pathway that provides resources and decision support in tapering.

Primary Outcome Measures

Name	Time	Method
Percentage of encounters tapering within CDC guidelines	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 Outcome Measures

Name	Time	Method
Subsequent opioid overdose/poisoning rates	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
Health care utilization	6 months after taper encounter	The number of emergency department and clinic visits
Clinical decision support (CDS) acceptance rate	18 months	The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway