Evaluation of Clinical Decision Support in Opioid Tapering

NCT ID: NCT06527079

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Usual Care

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

No interventions assigned to this group

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.

Opioid Tapering Pathway Clinical Decision Support (CDS)

Intervention Type: 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.

Interventions

Opioid Tapering Pathway Clinical Decision Support (CDS)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason Hoppe, DO

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Central Contacts

Heather Tolle, PhD

Role: CONTACT

heather.tolle@cuanschutz.edu

303-724-9924

Other Identifiers

24-1193

Identifier Type: OTHER

Identifier Source: secondary_id

R61DA057610

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-1193

Identifier Type: -

Identifier Source: org_study_id