Clinical trial NCT02770612: Shared Decision Making for Prescription Opioids After Cesarean Delivery
Official title: Shared Decision Making for Prescription Opioids After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Cesarean Section
Prescriptions
Analgesics, Opioid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-05-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Management and Opioid Usage Measured by Telephone Questionnaire
timeFrame: Within 2 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.