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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-cesarean delivery mothers | Other |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescribed opioids | Other | Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain Management and Opioid Usage Measured by Telephone Questionnaire | Outpatient opioid selection and use after discharge | Within 2 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28594762 | Derived | 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. |
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1 individual met exclusion criteria after agreeing to participate, due to postoperative length of stay > 7 days, and was not consented
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| ID | Title | Description |
|---|---|---|
| FG000 | Post-cesarean Delivery Mothers | Intervention: 10-minute shared decision making session via tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Massachusetts General Hospital | Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Management and Opioid Usage Measured by Telephone Questionnaire | Outpatient opioid selection and use after discharge | Posted | Median | Inter-Quartile Range | number of oxycodone 5mg tablets | Within 2 weeks postpartum |
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|
2 weeks for each participant, as this was the timing of the post-discharge phone call
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Post-cesarean Delivery Mothers | Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian T Bateman | Brigham and Women's Hospital | 617-278-0930 | bbateman@partners.org |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type of cesarean delivery | Count of Participants | Participants |
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| Timing of cesarean delivery | Count of Participants | Participants |
|
| Postoperative length of stay | Median | Inter-Quartile Range | days |
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| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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