NCT03678870

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 5, 2020

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

September 18, 2018

Results QC Date

January 27, 2020

Last Update Submit

February 4, 2020

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

  • Opioid Use

    Median number of tablets of hydrocodone-acetaminophen used after hospital discharge

    6 weeks postpartum

Secondary Outcomes (3)

  • Disposed of Opioids Correctly

    6 weeks postpartum

  • Analgesic Quiz Score

    6 weeks postpartum

  • Additional Prescriptions

    6 weeks postpartum

Study Arms (2)

Education

EXPERIMENTAL

Opioid Education

Other: Opioid Education Handout

Control

NO INTERVENTION

standard discharge instructions, which lists medications prescribed at discharge

Interventions

Opioid Education HandoutOTHER

a single page handout with information about how to use medications for pain after discharge.

Education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing cesarean delivery at VUMC
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women 18-45 years old
  • Women undergoing cesarean delivery at VUMC

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Osmundson

Nashville, Tennessee, 37215, United States

Location

Related Publications (2)

  • 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.

    PMID: 33716134DERIVED

  • 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.

    PMID: 33451618DERIVED

Results Point of Contact

Title
Sarah Osmundson, Assistant Professor of Obstetrics and Gynecology
Organization
Vanderbilt University Medical Center
sarah.osmundson@vumc.org
(615) 343-7869‬

Study Officials

  • Sarah Osmundson, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Ob/Gyn

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 20, 2018

Study Start

September 1, 2018

Primary Completion

February 1, 2019

Study Completion

November 1, 2019

Last Updated

February 17, 2020

Results First Posted

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)