- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678870
Discharge Opioid Education to Decrease Opioid Use After Cesarean
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
Study Overview
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
- 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
- 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
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
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37215
- Sarah Osmundson
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women 18-45 years old
- Women undergoing cesarean delivery at VUMC
Exclusion Criteria:
- Major post-surgical complications:
- cesarean hysterectomy, bowel or bladder injury, reoperation, ICU admission, wound infection or separation
- Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for > 7 days during pregnancy.
- Women who do not speak English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Education
Opioid Education
|
a single page handout with information about how to use medications for pain after discharge.
|
NO_INTERVENTION: Control
standard discharge instructions, which lists medications prescribed at discharge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Use
Time Frame: 6 weeks postpartum
|
Median number of tablets of hydrocodone-acetaminophen used after hospital discharge
|
6 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disposed of Opioids Correctly
Time Frame: 6 weeks postpartum
|
Frequency of women reporting that they either returned their unused opioids to a pharmacy or flushed them down the toilet
|
6 weeks postpartum
|
Analgesic Quiz Score
Time Frame: 6 weeks postpartum
|
Median score on an assessment of characteristics of analgesics including side effects, risks, and benefits.
Score 1-10 for each question.
Higher score is better.
|
6 weeks postpartum
|
Additional Prescriptions
Time Frame: 6 weeks postpartum
|
Percentage of patients obtaining additional prescriptions for pain
|
6 weeks postpartum
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sarah Osmundson, MD, Vanderbilt University Medical Center
Publications and helpful links
General Publications
- Schirle LM, Dietrich MS, Lam L, Stone AL, Bruehl S, Osmundson SS. Accuracy of patient-reported versus real-time electronic postoperative opioid use outcomes. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100347. doi: 10.1016/j.ajogmf.2021.100347. Epub 2021 Mar 11. No abstract available.
- Lam L, Richardson MG, Zhao Z, Thampy M, Ha L, Osmundson SS. Enhanced discharge counseling to reduce outpatient opioid use after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100286. doi: 10.1016/j.ajogmf.2020.100286. Epub 2020 Dec 3.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 181190
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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