Shared Decision Making for Prescription Opioids After Cesarean Delivery

Not Applicable

Completed

• Conditions: Pregnancy; Analgesics, Opioid; Prescriptions; Cesarean Section

• Registration Number: NCT02770612
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2017-06-19
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-05
• Last Update Submitted: 2019-03-05
• Results First Posted: 2019-03-07
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Postpartum women who underwent a cesarean delivery at MGH

Exclusion Criteria

• Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
• Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
• Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
• Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
• Women with impaired decision-making abilities
• Women hospitalized for > 7 days related to CD
• Minors (<18 years old)
• Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
• Women with contraindications to taking acetaminophen or NSAIDs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain Management and Opioid Usage Measured by Telephone Questionnaire	Within 2 weeks postpartum	Outpatient opioid selection and use after discharge

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States