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 examine the state of tapering in primary care across the system as well as conduct stakeholder interviews to understand the resources available across the system to support providers in tapering and identify opportunities for clinical decision support to be implemented to support guideline concordant tapering. Utilization of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering will be examined. The rate of opioid tapering in line with CDC guidelines will be examined as well as long term patient outcomes of opioid overdose of poisoning using existing patient health records. The study period will be approximately 8 months.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of potential taper-benefit patients

  The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial

  8 months

Secondary Outcomes (2)

• Observed tapering

  8 months

• Taper magnitude

  8 months

Study Arms (1)

Usual Care

Control group to enable tracking of temporal changes in prescribing. Providers will not see any alert.

Other: Observational study without a prospective intervention

Interventions

Observational study without a prospective intervention OTHER

observational study without a prospective intervention

Usual Care

Eligibility Criteria

• Age: 12 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• 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

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

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.