Shared Decision Making for Prescription Opioids After Cesarean Delivery

NCT02770612 | Completed Results

• 1 other identifier: 2016P000251
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Cesarean Section; Prescriptions; Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• Pain Management and Opioid Usage Measured by Telephone Questionnaire

  Outpatient opioid selection and use after discharge

  Within 2 weeks postpartum

Study Arms (1)

Post-cesarean delivery mothers

OTHER

1. Identify eligible women on post-operative day 3. A physician member of the study team will approach participants with study information and consent forms. 2. After informed consent is obtained, the participant will be taken through a 10 minute shared decision making session (intervention). The participant will then have the opportunity to ask questions, following which they will indicate the number of prescription opioid tablets to be discharged with (primary outcome) 3. The next contact will be at two weeks after discharge, at which time a member of the study team will contact the participant and administer a brief telephone survey with questions pertaining to perceived pain over time, pain management methods, opioid/pain medication consumption/disposal, and satisfaction with postoperative pain control. 4. A chart review will be performed by physicians in the research group on participants to gather information on demographics, indications for surgery, etc.

Other: Prescribed opioids

Interventions

Prescribed opioids OTHER

Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge

Post-cesarean delivery mothers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum women who underwent a cesarean delivery at MGH

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.

  PMID: 28594762 DERIVED

Results Point of Contact

• Title: Brian T Bateman
• Organization: Brigham and Women's Hospital

bbateman@partners.org

617-278-0930

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 7, 2019
• Results First Posted: March 7, 2019

Record last verified: 2019-03

Locations

US (1)