Discharge Opioid Education to Decrease Opioid Use After Cesarean

February 4, 2020 updated by: Sarah Osmundson, Vanderbilt University Medical Center

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

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

196

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Sarah Osmundson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sarah Osmundson, MD, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (ACTUAL)

September 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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