Clinical Decision Support for Safety of Opioid Transitions

April 20, 2026 updated by: University of Colorado, Denver
The objective of this study is to evaluate the impact of clinical decision support (CDS) alert to notify providers when the opioid prescription being written will result in the patient transitioning into a new phase of opioid therapy. The 2022 CDC clinical practice guideline for prescribing opioids for pain recommends providers reassess patient pain as well as the risks and benefits of opioid therapy before patients transition from acute to subacute treatment (1 month of opioid analgesics) and when patients transition from subacute to chronic opioid treatment (3 months). This study will evaluate a clinical decision support tool identifying patients who will be transitioning between phases as a result of an opioid prescription and suggest a review of patient pain and goals. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will not be notified that the prescription transitions the patient to a new phase but will have access to the same patient pain scales and information. The intervention arm will receive a notification of the transition and suggest review of patient needs and encourage documentation. Opioid transition orders and outcomes of patients will be examined based on medical records data collected during routine care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 and receive an opioid prescription.

Description

Inclusion Criteria: Any primary care encounter where an opioid is prescribed that transitions the patient to a different stage of opioid therapy (acute to subacute after 1 month of opioids; subacute to chronic after 3 months of an opioid)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Usual Care
Control group of contemporary encounters where clinical decision support alert is not active. Usual care.
Clinical Decision Support (CDS): Opioid transition alert
Encounters 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).
Other: Opioid Transitions Clinical Decision Support (CDS)
Clinical 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of encounters with an opioid transitioning prescription
Time Frame: 18 months
The number of primary care encounters where an opioid prescription transitions a patient to a different phase of care (by phase) divided by the total number of opioid prescriptions
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical decision support (CDS) acceptance rate
Time Frame: 18 months
The number of times providers accepted the Clinical decision support (CDS) tool and documented a review of patient pain and goals
18 months
Subsequent opioid overdose/poisoning rates
Time Frame: Six months after an encounter where the opioid use disorder is identified
The number of patients who reached the threshold of chronic opioid use, had a diagnosis of opioid overdose/poisoning or a new diagnosis of opioid use disorder
Six months after an encounter where the opioid use disorder is identified
Opioid prescription abandonment
Time Frame: 18 months
The proportion of opioid prescriptions initiated (triggering the CDS) and an opioid was not signed by the provider, indicating a change in clinical decision to prescribe an opioid
18 months
Number of patients with long term opioid use
Time Frame: Six months after an encounter where the opioid use disorder is identified
Count of patients receiving >90 day supply of opioids
Six months after an encounter where the opioid use disorder is identified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Hoppe, DO, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-1192
  • 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 quantitative EHR data utilized in this project will be housed on the National Addiction and HIV Data Archive Program (NAHDAP) website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings