Evaluation of Clinical Decision Support in Opioid Tapering

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-89
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Opioid Tapering Pathway Clinical Decision Support (CDS)

    Other intervention

    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.

Treatment groups

200,000 Participants
are divided into 2 treatment groups
Group A: Usual Care0 interventions
Group B: CDS Notification1 intervention

Trial outcomes

Primary outcomes

1

Percentage of encounters tapering within CDC guidelines

The number of encounters where a provider's actions are in line with CDC tapering guidelines divided by the total number of opioid tapering prescriptions

Time frame
18 months

Secondary outcomes

1

Clinical decision support (CDS) acceptance rate

The number of times providers accepted the clinical decision support (CDS) tool and utilized the clinical care pathway

Time frame
18 months
2

Subsequent opioid overdose/poisoning rates

The number of patients who had a diagnosis of opioid overdose or poisoning in the six months following an opioid tapering prescription

Time frame
6 months after taper encounter
3

Health care utilization

The number of emergency department and clinic visits

Time frame
6 months after taper encounter

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

National Institutes of Health (NIH)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: