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Shared Decision Making for Prescription Opioids After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT02770612
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Brian Bateman, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Pregnancy Cesarean Section Prescriptions Analgesics, Opioid Other: Prescribed opioids Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Shared Decision Making for Prescription Opioids After Cesarean Delivery
Study Start Date : April 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770612


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Bateman, MD, MSc, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02770612     History of Changes
Other Study ID Numbers: 2016P000251
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016

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