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OpenTrials
Completed

NCT Number: NCT04446975

Best Practice Alert for Opioid Prescribing

The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial.

Preliminary data indicate that current opioid prescription practice after surgery follows a "one size fits all" pattern. In-hospital opioid use prior to discharge serves as a reliable indicator to estimate needs for analgesic medications at home. The investigators will test the hypothesis that the existing tool will enable providers to write need-based prescriptions based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The investigators will test this tool prospectively in a cohort of ~1,000 providers (primary subjects) and ~39,000 surgical patients (secondary subjects) in four University of Colorado Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the intervention).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this aim is to prescribe pain medications after surgery in a patient-centered fashion. The investigators have used the average amount of opioid medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated "prior to discharge daily MME dose" will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be displayed when the electronic order entry for the post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In addition, the provider will be prompted to also prescribe non-opioid analgesic medications. This BPA was developed by the Principal Investigator under guidance of the UCHealth System Multidisciplinary Opioid/Pain Management Committee as well as published guidelines.

Based on the relationship between opioids taken prior to discharge and post-discharge opioid intake described above as well as published guidelines for post-discharge prescriptions after surgery will use a tiered approach towards determining the total amount of opioids to be prescribed. Accordingly, the investigators have integrated an algorithm into the BPA such that opioid intake from the EHR only triggers the BPA if the total amount of prescribed opioids exceeds the predicted thresholds.

The opioid prescribing BPA will be assessed over a 44-week period in all eligible patients. At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider and will be tracked. The investigators will use an all "On" vs. all "Off" configuration to answer the questions if the average amount of total opioids per post-discharge prescription is lower with the BPA active. The investigation will commence with two "Off" periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two "On" periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Primary subjects:

  • Credentialed providers (attending, fellow, and resident physicians, advanced practice providers including nurse practitioners and physician assistants) at each UCH (UC Health) site writing a discharge opioid prescription are eligible to receive the intervention.

Secondary subjects:

  • Adult surgical inpatients age 18 and older within the UCHealth system at 4 different hospitals including UCH Metro, UCH Memorial Central, Medical Center of the Rockies, and Poudre Valley Hospital.

Exclusion criteria

Primary subjects:

  • None

Secondary subjects:

  • Less than 18 years of age.

Treatment and study plan

BPA

Other

At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.

Primary outcomes

  1. Opioids Prescribed at Discharge

    Time frame: 1 day, on discharge date from hospital

    Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record

Secondary outcomes

  1. Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge

    Time frame: 1 day, on discharge date from hospital

    Number of Participants prescribed discharge non-opioid analgesic medications (opioid/non-opioid combination formulations) as recorded in the electronic health record

  2. Number of Participants With Opioid Prescriptions After Discharge

    Time frame: "Day of discharge +1" until 28 days after discharge

    Number of participants with opioid prescriptions after discharge as recorded in the electronic health record

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • University of Nebraska

Registry information

Official study title

Best Practice Alert for Post-Surgical Opioid Prescribing At Discharge

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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