Shared Decision Making for Prescription Opioids After Cesarean Delivery

Pregnancy Clinical Trial

Official title:

Shared Decision Making for Prescription Opioids After Cesarean Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770612
• Other study ID #: 2016P000251
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 2016

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesics, Opioid
• Cesarean Section
• Pregnancy
• Prescriptions

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Management and Opioid Usage Measured by Telephone Questionnaire	Outpatient opioid selection and use after discharge	Within 2 weeks postpartum