24-hour Oral Morphine Equivalent Based Opioid Prescribing After Surgery
Condition: Opioid Use
Study type: Interventional

Summary: 
      The investigators will utilize the electronic health record to individualize pain therapy in
      surgical patients after hospital discharge using last 24-hour opioid intake as the decision
      variable for the amount of opioid pain pills prescribed. The preliminary data indicate that
      current opioid prescription practice after surgery follows a "one size fits all" pattern.
      In-hospital opioid use 24 hours prior to discharge serves as a strong indicator to correctly
      estimate needs for analgesic medications at home. The investigators will test the hypothesis
      that this prescription estimation tool will enable providers to write need-based
      prescriptions based on each patient's' 24-hour prior-to-discharge opioid use. The
      investigators will test this tool prospectively for patients after Cesarean section who are
      anticipated to use about half or less of the usually prescribed amount of opioid pain pills
      after discharge randomized equally to prescription tool intervention or no intervention
      (prescription as usual).
    

Detailed description: 
      Prescription opioid overdose has emerged as a leading cause of death in the general
      population. Opioid-based therapy represents a corner-stone of post-operative pain management.
      With increasing emphasis on robust pain therapy, sales of opioid medications have increased
      four-fold in the last decade. Parallel to this rise, opioid-associated deaths have also
      quadrupled. The investigators have shown that long-term opioid use occurs in up to 22% of
      patients following surgery. Over-prescribed opioids after surgery can create a reservoir of
      opioids that become available for non-medical use. Effective strategies to maximize
      non-opioid pain therapy and to limit such a reservoir are lacking. Thus, there is an urgent
      need to individualize post-operative pain therapy and reduce reliance on opioids.

      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 study is to prescribe pain medications after surgery in a
      patient-centered fashion. The investigators will use the average amount of opioid medications
      (in oral morphine equivalents - OME) taken in the last 24 hours prior to discharge to inform
      and design a clinical decision support tool. This tool will reduce the amount of opioid
      medications prescribed while maintaining patient post-operative pain control. The calculated
      "last 24 hour OME dose" will be applied to generate a recommendation for the prescription of
      a cumulative opioid dose that will be shared with the provider when the post-discharge pain
      medication is made, e.g. via displaying the last 24-hour opioid use in the electronic health
      record (EHR). The rationale is that testing of such a decision-making tool will lay the
      groundwork to translate the findings of this project into more secure and efficient opioid
      prescribing practices to a system-wide level. Upon completion, the investigators expect to
      have developed an effective decision-making tool to help providers estimate required pain
      medication following patient discharge.

      The investigators will perform a randomized clinical trial (RCT) of an Electronic Health
      Record (EHR)-based recommendation to prescribe opioids at discharge according to the recorded
      last 24-hour inpatient use according to current recommendations and evaluate its effect on
      the amount of opioids prescribed as well as pain control after discharge.

      Using the University of Colorado Hospital Epic/Clarity database, the investigators will
      continuously identify all patients who underwent Cesarean section surgery at University
      Hospital. Patients will be approached regarding interest in the study prior to hospital
      discharge.A trained Professional Research Assistant or other provider will explain the study
      and obtain informed consent from prospective participants. After consent, demographics and
      the best contact information will be collected from those enrolled patients who indicate they
      are interested in completing the surveys after their hospital discharge.

      The investigators expect 44 patients to complete all four weekly surveys and define the
      intent-to-treat sample as patients who complete one or more surveys (providing at least one
      observation to be used in analyses). To conservatively allow for increased variability due to
      attrition, 54 patients will be randomized equally electronically to intervention
      (prescription tool) or no intervention (prescription as usual). The investigators will use an
      electronic randomization scheme created so that the principal investigator and statistician
      can remain blind to assignment.

      In the intervention group (Arm 2), at the time of writing the prescription for a patient, the
      provider will be informed that a patient may be considered for a lower post-discharge opioid
      dose (No opioids for patients who did not take any opioids in the last 24 hours, and 10
      oxycodone 5mg tablets, for patients having taken equal or less than 22.5 MME (morphine
      milligram equivalent), e.g. 1-3 oxycodone 5mg tablets in the last 24 hours.) In the control
      group (Arm 1), providers will receive a message to consider prescribing the usual medications
      for pain management after discharge. Final dosing decisions and drug choices will remain at
      the discretion of the treating provider and decisions will be tracked. For this pilot study,
      the provider information (best practice alert - BPA) will be operationalized via a written
      recommendation on paper handed to the provider by study staff in a sealed envelope that the
      provider will be asked to open and read. Alternatively the BPA may be presented
      electronically using a screen. Providers will be asked to acknowledge that they read the BPA
      by closing the window or opening the envelope.

      One week after hospital discharge interested patients will be contacted and asked to complete
      the first of four surveys. All communication will be available in English. Patients will be
      paid with a $10 gift card or money order equivalent to complete the study assessments using
      REDCap at each of the four weekly follow-up time points ($40 total). All enrolled patients
      will complete the weekly post-discharge surveys within REDCap or hard copy if they do not
      have internet access.

      The study team will contact all subjects ~2 weeks after discharge to ask about pain
      management and monitor the need for secondary prescriptions from providers to ensure that no
      significant under-prescription of opioid medications after surgery occurs.

      The investigators will seek follow-up with providers about the usefulness and acceptability
      of the EHR-based intervention. Providers will be surveyed with a REDCap survey using a
      modified version of the GUIDES checklist, which provides a tool to improve the successful use
      of guideline-based computerized clinical decision support.
    

Intervention name(s): Arm 1 Prescription As Usual; Arm 2 Prescription Tool Intervention
Intervention type(s): Other; Other
Intervention description(s): At the time of writing the discharge prescription for a patient the provider will receive a best practice alert (BPA) to consider prescribing the usual medications for pain management after discharge.; The best practice alert (BPA) Prescription Tool will only make a suggestion to the provider if the patient may be considered for a lower post-discharge opioid dose. Providers may still choose to prescribe a higher dose as clinically indicated.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigators will test this tool prospectively for Cesarean section patients anticipated to use about half or less of the usually prescribed amount of opioid pain pills randomized equally to prescription tool intervention or no intervention (prescription as usual).
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: opioids