Clinical Decision Support for Safety of Opioid Transitions
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT06527040
- Status
- Not Yet Recruiting
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Conditions
- Harm Reduction
- Medication Abuse
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 89 Years
- Healthy Volunteers
- Accepted
Interventions
- Opioid Transitions Clinical Decision Support (CDS) — OTHERClinical decision support in the form of an electronic health record (EHR) integrated, provider-facing alert suggesting (a) the patient is transitioning to a new phase of opioid therapy and (b) the provider should review patient pain data and pain management goals as suggested by Center for Disease Control and Prevention (CDC) guidelines.
Study Details
The objective of this study is to evaluate the impact of a clinical decision support (CDS) alert designed to notify providers when an opioid prescription will result in a patient transitioning into a new phase of opioid therapy. The 2022 CDC Clinical Practice Guideline for Prescribing Opioids for Pain recommends that providers reassess patient pain, treatment goals, and the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and from subacute to chronic opioid treatment (3 months). This study will evaluate a CDS tool that identifies patients who will be transitioning between phases of opioid therapy as a result of a prescribed opioid medication and prompts providers to review patient needs and goals of care. A pre-post study design will be used to compare provider prescribing practices and patient outcomes before and after implementation of the CDS alert. During the pre-implementation period, providers will continue routine care and will have access to existing patient pain assessments and clinical information, but no transition alert will be displayed. During the post-implementation period, providers will receive a notification when an opioid prescription results in a transition to a new phase of therapy and will be encouraged to review patient needs, reassess pain and treatment goals, and document their clinical decision-making. Opioid transition orders, provider documentation, and patient outcomes will be evaluated using medical record data collected during routine clinical care and compared between the pre-implementation and post-implementation periods.
Key Dates
- First listed
- Jul 30, 2024
- Start date
- Dec 31, 2026
- Status verified
- Sep 2026
- Primary completion
- Apr 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 200,000 participants (estimated)
Arms
- Arm: pre-implementation periodEncounters with a high risk opioid prescription prior to intervention implementation. Providers will not see any alert. Usual care.
- Arm: Clinical Decision Support (CDS): Opioid transition alertEncounters where the opioid transition clinical decision support (CDS) alert fired. CDS logic is programmed to fire the alert when a provider places an order for an opioid that will transition the patient from acute to subacute opioid therapy (at 30 days) or from subacute to chronic opioid therapy (at 90 days).
Primary Outcome Measure
Percentage of encounters with an opioid transitioning prescription [ Time Frame: 18 months ]
Central Contacts
- Heather Tolle, PhD303-724-9924
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCHealth | Aurora | Colorado | 80045 |
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