Discharge Opioid Education to Decrease Opioid Use After Cesarean
Condition: Opioid Use
Study type: Interventional

Summary: 
      Background: The number of opioid overdose deaths in the United States has quadrupled in 15
      years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a
      sharp increase in the amount of legal prescription opioids dispensed. The abundance of
      prescription opioids available is a primary pathway for opioid abuse and diversion and higher
      opioid use after surgery has been associated with an increased risk of chronic opioid use.
      Reducing the amount of opioid used after cesarean delivery may decrease the risk of chronic
      opioid use and will help towards better estimating and reducing the amount of opioids
      prescribed at discharge.

      Objective: To to compare discharge opioid education to standard care to ascertain whether
      opioid education reduces opioid use after hospital discharge
    

Detailed description: 
      Background: The number of opioid overdose deaths in the United States has quadrupled in 15
      years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a
      sharp increase in the amount of legal prescription opioids dispensed. The abundance of
      prescription opioids available is a primary pathway for opioid abuse and diversion and higher
      opioid use after surgery has been associated with an increased risk of chronic opioid use.
      Reducing the amount of opioid used after cesarean delivery may decrease the risk of chronic
      opioid use and will help towards better estimating and reducing the amount of opioids
      prescribed at discharge.

      Objective: To to compare discharge opioid education to standard care to ascertain whether
      opioid education reduces opioid use after hospital discharge

      Preliminary Data: Our soon to be published study (Obstetrics & Gynecology Journal) found that
      30% of women used all their opioids after discharge for cesarean delivery because they "were
      following directions" and not because they had pain.

      Enrollment & Randomization

      Enrollment

        -  Participants will be approached after their cesarean delivery either in the recovery
           room or in their private postpartum room

        -  Informed written consent will be obtained by a trained research assistant (i.e. medical
           student) or by the study researchers (Attendings, fellows)

        -  After enrollment, participants will be asked to complete Survey 1 either in person or by
           giving sending them the web link with RedCap

      Randomization

        -  Enrolled patients will be randomized in a 1:1 ratio using permuted blocks of 6

        -  Randomization sequence will be developed through sealed envelope.com

        -  Randomization and allocation will be done through RedCap

      Study Procedures

        1. Enrollment

        2. Postoperative Day 0-1: Survey 1 through RedCap (takes ~10 minutes)

        3. Randomization education versus usual care

             1. Control = Standard discharge instructions, which list medications prescribed at
                discharge

             2. Intervention = a single page handout (see attachment) with information about how to
                use medications for pain after discharge. This handout contains the following
                instructions

                  -  Get baseline pain control with ibuprofen

                  -  Use your opioid prescription only if your pain is very bad

                  -  Taper your medications

                  -  Get rid of leftover opioid tablets

        4. At discharge all patients will receive the follow medications using PillsyCaps. These
           are standard medications given at discharge at our institution

             -  Ibuprofen 600mg: 30 tablets

             -  Hydrocodone 5mg -acetaminophen 325mg: 30 tablets

        5. Postoperative day 14: All participants will be contacted to complete Survey 2 (Takes ~
           15 minutes

             -  Attempts to contact each participant will be done 3 times before they are
                designated as "lost to follow up"

             -  If a participant is still using opioids on postoperative day 14, they should be
                contacted weekly until they are no longer taking opioids

      Primary Outcome Median number of tablets of hydrocodone-acetaminophen used after hospital
      discharge

      Secondary Outcomes:

        -  Visual Analog Scale pain score (median)

        -  Percentage of patients reporting pain since discharge as worse than expected

        -  Percentage of patients obtaining additional prescriptions for pain

        -  Percentage of patients with unscheduled visits for pain

        -  Mean ibuprofen milligrams used hours 24-47 after cesarean

        -  Mean acetaminophen milligrams used hours 24-47 after cesarean

        -  Total Morphine Milligram Equivalents (MME) used per hour of inpatient stay

      Risks

      o Breach of confidentiality of protected health information

      Reporting Adverse Events Any adverse events or unanticipated problems involving risk to
      participants or others will be reported to the Institutional Review Board and the Vanderbilt
      University Medical Center (VUMC) privacy office within 7 days of discovery.

      Study Withdrawal/discontinuation Participants may withdraw at any time by providing written
      intent to the Primary Investigator. Participants may be removed from the study if they
      develop a major surgical complication after their cesarean.

      Statistical Considerations

      Using prior data, the average opioid MME used per person was 130 MME (SD 90) in the "average
      use" group. With an alpha of 5% and a beta of 80%, we estimate that 160 total participants
      are required to show a 30% reduction in opioid used. Assuming a lost to follow up rate of
      20%, we plan to enroll 200 women.

      Follow-up and Record Retention On average 100 cesareans are performed per month. With a 50%
      enrollment rate, we anticipate this study will take 4 months to complete

      The patient list will be destroyed upon data analysis and publication. Redcap will be
      archived upon publication.
    

Intervention name(s): Opioid Education Handout
Intervention type(s): Other
Intervention description(s): a single page handout with information about how to use medications for pain after discharge.
Intervention MeSH terms: Analgesics, Opioid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment