Evaluation of Clinical Decision Support in Opioid Tapering

NCT06527079 | Not Yet Recruiting

• 2 other identifiers: 24-1193R61DA057610
• Study Type: observational
• Target: 200,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Medication Abuse; Harm Reduction; Opioid Use Disorder; Opioid Prescribing; Opioid Overdose; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical decision support (CDS) acceptance rate

  18 months

• Subsequent opioid overdose/poisoning rates

  6 months after taper encounter

• Health care utilization

  6 months after taper encounter

Study Arms (2)

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)

Interventions

Opioid Tapering Pathway Clinical Decision Support (CDS) OTHER

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.

CDS Notification

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Substance-Related Disorders; Harm Reduction; Opioid-Related Disorders; Opiate Overdose

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior; Narcotic-Related Disorders; Drug Overdose; Prescription Drug Misuse; Drug Misuse

Study Officials

• Jason Hoppe, DO

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Tolle, PhD

CONTACT

303-724-9924; heather.tolle@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be provided to NAHDAP after study results are published in peer-reviewed journals.
• Access Criteria: Prior to downloading study data, the individual will have to register with the site and agree to a standard data use agreement.