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.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use Disorder; Harm Reduction; Prevention; Opioid Overdose; Opioid Prescribing; Medication Abuse
• Intervention / Treatment: Other: Opioid Tapering Pathway Clinical Decision Support (CDS)

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Heather Tolle, PhD; Phone Number: 303-724-9924; Email: heather.tolle@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system receiving long-term opioid treatment.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Usual Care; Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.
CDS Notification; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of encounters tapering within CDC guidelines	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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical decision support (CDS) acceptance rate	The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway	18 months
Subsequent opioid overdose/poisoning rates	The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following an opioid tapering prescription	6 months after taper encounter
Health care utilization	The number of emergency department and clinic visits	6 months after taper encounter

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jason Hoppe, DO, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 24, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Chemically-Induced Disorders; Drug Overdose; Prescription Drug Misuse; Behavior; Opiate Overdose; Opioid-Related Disorders; Substance-Related Disorders; Harm Reduction; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 24-1193 (Other Identifier: COMIRB); R61DA057610 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) repository after final study results have been published.
• IPD Sharing Time Frame: Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
• IPD Sharing Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No