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Shared Decision Making for Prescription Opioids After Cesarean Delivery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Bateman, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02770612
First received: May 9, 2016
Last updated: October 12, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Pregnancy Cesarean Section Prescriptions Analgesics, Opioid Other: Prescribed opioids

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Shared Decision Making for Prescription Opioids After Cesarean Delivery

Resource links provided by NLM:


Further study details as provided by Brian Bateman, Massachusetts General Hospital:

Primary Outcome Measures:
  • Pain management and opioid usage measured by telephone questionnaire [ Time Frame: Within 2 weeks postpartum ]
    Pain management and opioid usage measured by telephone questionnaires completed 2 weeks after discharge


Enrollment: 50
Study Start Date: April 2016
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Massachusetts General Hospital
  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. 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.
  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 additional information on demographics, indications for surgery, and other relevant variables.
Other: Prescribed opioids
Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02770612

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

Responsible Party: Brian Bateman, MD, MSc, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02770612     History of Changes
Other Study ID Numbers: 2016P000251
Study First Received: May 9, 2016
Last Updated: October 12, 2016

Additional relevant MeSH terms:
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 23, 2017