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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
Full 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
Randomization
Study Procedures
Enrollment
Postoperative Day 0-1: Survey 1 through RedCap (takes ~10 minutes)
Randomization education versus usual care
Control = Standard discharge instructions, which list medications prescribed at discharge
Intervention = a single page handout (see attachment) with information about how to use medications for pain after discharge. This handout contains the following instructions
At discharge all patients will receive the follow medications using PillsyCaps. These are standard medications given at discharge at our institution
Postoperative day 14: All participants will be contacted to complete Survey 2 (Takes ~ 15 minutes
Primary Outcome Median number of tablets of hydrocodone-acetaminophen used after hospital discharge
Secondary Outcomes:
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.
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Masking
196 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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