Shared Decision Making for Prescription Opioids After Cesarean Delivery

NCT ID: NCT02770612

Last Updated: 2019-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Post-cesarean delivery mothers

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.

Group Type: OTHER

Prescribed opioids

Intervention Type: OTHER

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

Interventions

Prescribed opioids

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brian Bateman

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28594762 (View on PubMed)

Other Identifiers

2016P000251

Identifier Type: -

Identifier Source: org_study_id