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 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
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
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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?
Design Details
- Observational Models: COHORT
- Time Perspectives: RETROSPECTIVE
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. |
observational study without a prospective intervention |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of potential taper-benefit patients
Time Frame: 8 months
|
The percentage of chronic opioid primary care patients for which EHR risk indicates tapering may be beneficial |
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Observed tapering
Time Frame: 8 months
|
The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly as an indication of tapering |
8 months
|
|
Taper magnitude
Time Frame: 8 months
|
The percentage of primary care patients with sustained opioid morphine milligram equivalence (MME) rates declining monthly at a rate in line with guideline recommendations |
8 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason Hoppe, DO, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-1193
- R61DA057610 (U.S. NIH Grant/Contract)
- 24-1193 (Other Identifier: COMIRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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
Studies a U.S. FDA-regulated device product
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